Wire navigation system

This is a Request for Information (RFI) – Sought Notice Only. This notice is issued solely for information and planning purposes only.

1. The US Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder; not responding to this notice does not preclude participation in any further RFQ; IFB or RFP if issued.
 

2. The associated North American Industry Classification System (NAICS) is 334510. The business size standard is 1250 Employees. All contractors doing business with the Department of Defense shall be registered and approved through the System for Award Management (SAM). This is the Official U.S. Government system that consolidates the capabilities of CCR/FedReg, and EPLS. There is no fee to register for this site. Entities may register at no cost directly from this page. The proposed performance start date will be on or about 1 July 2026. The Solicitation number is W81K0426QA055.
 

3. Note – Prior to award your company shall reflect the NAICS Code 334510 identified on your SAM. If your company is interested in competing on this project, and have services, please submit the following documentation no later than  12 May 2026, 10:00 AM EST, to Cynthia A. Richardson-Rhone and Jason Holck at cynthia.a.richardson-rhone.civ@health.mil.  All questions need to be submitted NLT 8 May 2026 by 9:00 AM EST.

Your email response shall provide the following:

Can you provide the following:

The required system is a hybrid-reality simulator for orthopedic surgical training, specifically for procedures involving guidewire navigation under simulated fluoroscopy. The system must provide a radiation-free environment that combines physical models with real-time, computer-generated imaging to teach and assess surgical skills. 

SalientCharacteristics:

Minimum Clinical Performance Requirements

•  Radiation-Free Fluoroscopy: The system must simulate C-arm fluoroscopic imaging (both Anterior-Posterior and Lateral views) without the use of ionizing radiation, ensuring trainee safety.
• Real-Time Instrument Tracking: Must utilize a camera-based optical tracking system to continuously determine the three-dimensional position and orientation of a surgical instrument.
•  Proprietary Bar-Coded Guidewire: The system must use a proprietary, laser-etched, bar-coded guidewire that is recognized by the camera system to calculate its precise trajectory and depth. The system software must project the virtual representation of this wire onto the simulated fluoroscopic images.
•  Computer-Generated Imaging: The included laptop and software must generate realistic, real-time simulated X-ray images that accurately reflect the interaction between the tracked guidewire and the anatomical model.

Physical and Haptic Feedback

•  Physical Anatomical Models: The system must use physical, replaceable anatomical models (e.g., surrogate bones) that allow the trainee to perform the physical act of drilling.
• Realistic Haptic Sensation: The bone models must be constructed from materials of varying densities (e.g., dense foam) to provide realistic haptic feedback that distinguishes between drilling through cortical bone and cancellous bone.

Soft-Tissue Simulation: Must include a synthetic soft-tissue envelope that covers the bone model to simulate the tactile experience of passing the guidewire through tissue layers before engaging the bone.

System Components and Interface

•  Hardware Platform: Must include a main simulator unit that securely houses the tracking cameras and the anatomical training models.
•  Control Interface: Must include a foot pedal that allows the user to acquire and switch between simulated AP and lateral fluoroscopic images, mimicking the functionality of a real C-arm.
• Pre-configured Laptop: The system must be delivered with a laptop computer that has all necessary simulation and control software pre-installed and configured.

Training, Assessment, and Validation

•  Objective Performance Metrics: The software must be capable of capturing and reporting on objective performance metrics for trainee assessment. Required metrics include, but are not limited to:
  • Total procedure time.
  • Total simulated fluoroscopy time/number of images acquired.
  • Number of wire redirections.
  • Final wire placement accuracy (e.g., Tip-Apex Distance).
•  Validated Training Efficacy: The simulator must be supported by peer-reviewed research studies demonstrating its effectiveness in distinguishing between novice and expert users and proving that skills acquired on the system transfer to a clinical or mock-clinical environment.

Modularity and Extensibility

•  Modular Design: The system must be designed to be modular, allowing for the use of different training modules for various orthopedic procedures on the same base hardware platform. Compatible modules must include, at a minimum, Hip Navigation, Pediatric Elbow Pinning, and Sacroiliac (SI) Screw placement.

Please ensure to address the below:

Name of Company
Point of contact
Phone number
Email address
Identify Your Small Business Socio-Economic Group
DUNS number and CAGE Code

4. This requirement No telephonic inquiries will be responded to. A solicitation will be posted within 2-3 weeks www.Sam.gov.