Attachment H - Down Selection Evaluation Criteria (REVISED) - Amendment 0002 (showing changes).pdf

Attachment H – Down Selection Evaluation Criteria

The ultrasound system will be evaluated and down selected based on the following evaluation criteria:

For down select purposes, system attributes that are weighted as “high” are more important than system attributes weighted as “medium” and “low,” during environmental and operational testing. Additionally, systems attributes that meet the objective will be evaluated “higher,” in comparison to system attributes only meeting the threshold.

Price and overall usability will also be considered. Down selection will be based on a comprehensive review and assessment against the evaluation factors below.

Evaluation Factors:

Environmental testing Operational Assessment/Usability Pricing Reasonableness

‐ Environmental Testing The Ultrasound SField Portable (USFP) system will undergo environmental testing. The system will be rated according to the data received and how the system performed in each attribute below.

according to the below attributes.

‐ Operational Assessment/Usability o The Operational Assessment will contain scenarios in a simulated operational environment where military end-users will use the USFP system and then will provide feedback. The system will be rated according to the information received in the feedback and how the system performed according to the below attributes during the Operational Assessment.

o Overall usability of the entire USFP system (including accessories) will be considered and rated, which may include other attributes in the MIL-STD-810. “Usability” is defined as the effectiveness, efficiency, ease of use and user satisfaction while an end-user interacts with the USFP system in a simulated operational environment.

‐ Price Reasonableness o Price reasonableness of the 3,5001,137 USFP systems (Deliverable 123). For a price to be reasonable, it must, in its nature and amount, represent a price to the Government that a prudent person would pay in the conduct of competitive business. Normally, price reasonableness is established through price analysis.

Ratings

Ratings for Environmental

Testing attributes Description EXCEPTIONAL The USFP system attributes performed well under military environmental conditions, received no concerns from testing AND MEETS one or more OBJECTIVE attributes. Risk of unsuccessful performance is very low.

GOOD The USFP system attributes performed well under military environmental conditions and received no concerns from testing. Risk of unsuccessful performance is very low.

ACCEPTABLE The USFP system attributes performed well under military environmental conditions and received some minor concerns from testing AND meets the threshold. Risk of unsuccessful performance is low.

UNACCEPTABLE The USFP system attributes received one or more notable concern(s) from testing. USFP systems is not acceptable.

Ratings for Operational Assessment/

Usability Description EXCEPTIONAL The USFP system attributes performed well during operational assessment and received no concerns from military test users. Risk of unsuccessful performance is very low.

GOOD The USFP system attributes performed well during operational assessment and received some minor concerns from military test users. Risk of unsuccessful performance is low.

ACCEPTABLE The USFP system attributes received one or more notable concern(s) from military test users. There is risk of unsuccessful performance.

UNACCEPTABLE The USFP system was unable to perform the operational assessment and/or the end user was unable to use the system. USFP system is not acceptable and/or has critical failures.

Ratings for Price reasonableness Description ACCEPTABLE Pricing for the USFP system (including logistical support and all associated accessories) is fair, reasonable, and is competitively priced. The written price narrative reflects sound, rational judgment in deriving and applying historical data and pricing methodologies.

UNACCEPTABLE Pricing for the USFP system (including logistical support and all associated accessories) is not fair, reasonable, and/or competitively priced. The written price narrative does not reflect sound, rational judgment in deriving and applying historical data and pricing methodologies.

Attribute: Evaluation Weight:

Threshold: Objective:

U.S. FDA Clearance High Shall have U.S.

FDA Clearance

Shall have U.S. FDA Clearance

Power Source - High Shall have a rechargeable power source

Shall have a rechargeable and interchangeable power source

Focused Assessment with Sonography for Trauma (FAST) Capable

High

Shall be FDA Cleared for use in the abdomen and capable of performing FAST exams

Shall be FDA Cleared for use in the abdomen and capable of performing FAST examsShall be FDA cleared for performing FAST exams

Extended Focused Assessment with Sonography for Trauma (e-FAST) Capable

High

Shall be FDA Cleared for us e in the abdomen and for cardiac use, and capable of performing e- FAST exams

Shall be FDA Cleared for us e in the abdomen and for cardiac use, and capable of performing eFAST examsShall be FDA cleared for performing e-FAST exams

Musculoskeletal (MSK) Capable

High

Shall be FDA Cleared for musculoskeletal use and capable of performing

MSK/MSKI

exams

Shall be FDA Cleared for musculoskeletal use and capable of performing

MSK/MSKI

examsShall be FDA cleared for performing MSK exams

Reliability Medium The USFP system should have a 95% probability of completing 24 total run time hours within a 3-day timespan without a System Abort (SA), which equates to 468 hours Mean Time Between System Abort (MTBSA).

The USFP system should have a 95% probability of completing 24 total run time hours within a 3-day timespan without a System Abort (SA), which equates to 468 hours Mean Time Between System Abort (MTBSA).

Power Source Duration Low The power source should last for two hours at the highest setting

The power source should last for five hours or more at the highest setting

Power Source - low

Should have a rechargeable power source

Should have a rechargeable and interchangeable power source

Weight Low The complete USFP system (screen & transducer(s)) should not weight more than three pounds

The complete USFP system (screen & transducer(s)) should not weight more than

0.5 pounds

Size Low The complete USFP system (screen & transducer(s)) should be a cube of no more than 280 cubic inches

The complete USFP system (screen & transducer(s)) should be a cube of no more than 160 cubic inches

High Temperature Low The fully functional USFP system should be operational at all settings at 49°C

The fully functional USFP system should be operational at all settings at 60°C

Low Temperature Low The fully functional USFP system should be

The fully functional USFP system should be operational at all settings at -26°C operational at all settings at -1°C

Transducer(s) Low The USFP system should have transducers to perform FAST, e- FAST and MSK exams

The USFP system should have one transducer to perform FAST, e- FAST and MSK exams (can have multiple heads on transducer)

Storage Low The USFP system should have at least 8 GB of storage space

The USFP system should have at least 16 GB of storage space

(end of down selection evaluation criteria)