SOW- CDRH-2026-133563- Final Version.docx

SOW

1. Statement of Work (SOW) Updated two force plates and platform for gait analysis. SOW Format

· Background

· Objectives/Scope

· Tasks

· Delivery

· Place of performance

· Period of performance

2. Background In collaboration with the Human-Device Interaction lab within the Office of Science and Engineering Labs (OSEL), the Division of Biomedical Physics (DBP) seeks to order a portable force plate system for gait and balance assessment. The Human-Device Interaction lab within OSEL addresses regulatory science research questions related to diagnostic, therapeutic, and assistive medical devices. Understanding human interaction with these medical devices requires biomechanics equipment that quantifies human movement. Force plate analysis is a common method by which human gait and balance can be accurately quantified.

For this acquisition, a portable force plate system is needed to collect more robust, high-quality signals of human gait and balance. The system will allow for accurate quantification of subject movement. The services requested below are for the operations of the Center for Devices and Radiological Health (CDRH).

3. Objectives/Scope

For this acquisition, a portable force plate system is needed to collect more robust, high-quality signals of human gait and balance. The system will allow for accurate quantification of subject movement. The delivery of the portable force plate system requested are for the operations of the Center for Devices and Radiological Health (CDRH).

4. Tasks

The portable force plate system ordered must have the following salient characteristics:

· A minimum of two (2) force plates capable of exporting data from at least six (6) measurement channels including force in the X, Y, and Z axes and moment in the X, Y, and Z axes. The following horizontal and vertical force and moment capacities must be met:

· Force X, Y capacity must be greater than 430 Newtons.

· Force Z capacity must be greater than 1300 Newtons.

· Moment X, Y capacity must be greater than 225 Newton-meters.

· Moment Z capacity must be greater than 80 Newton-meters.

· Uses a plug & play Universal Serial Bus (USB) (2.0 or greater) interface capable of connecting and synchronizing up to 12 force plates. All cables and accessories required for synchronization should be included.

· Generates digital output of at least six measurement channels (described above) that uses a single USB cable to connect with an acquisition computer running Windows 10 and is easily integrated in Vicon Nexus 2.X software.

· Compatible with Vicon Nexus software versions 2.6 through 2.19 (or latest available version)

· Includes necessary drivers, plugins, or SDK components for integration

· Real-time data streaming capability to Vicon Nexus environment

· Includes at least 15-foot USB cable for power and data transfer

· Force plates allow for user selectable digital data rates between 10-1000 datasets per second.

· Force plates do not require an external amplifier. Amplifier must be bult into the force plate.

· Force plate dimensions are no greater than 51 x 51 x 4.6 centimeters with a 300-pound (or greater) vertical force capacity.

· Force plate is portable such that it does not require any mounting and weighs less than 12 kilograms.

· Hardware solutions are provided to recess the force plates into raised flooring such that data accuracy and integrity are not compromised.

· The Contractor shall provide a minimum one (1) year hardware warranty from date of Government acceptance. The Contractor shall guarantee full device replacement at no additional cost to the Government for any manufacturing defects or operational failures during normal use as defined in the user manual. Warranty coverage shall include all associated shipping costs for replacement units.

5. Delivery

Hardware associated with the portable force plate system to be delivered no later than 60 days after award.

SHIP TO:

Attn: Kimberly Kontson 10903 New Hampshire Ave Building 62-1105 Silver Spring, MD 21140

Point of contact:

Kimberly Kontson Kimberly.Kontson@fda.hhs.gov Office phone: (301) 798-4990

6. Place of Performance One time purchase of equipment.

7. Period of Performance One time purchase of equipment. One (1) year hardware warranty.