Spectroradiometer With Specialized Lens for Characterizing Head Mounted Displays

Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. Background: The procurement is to support regulatory science tools development for the Interventional, Radiological Imaging and Visualization program. Developing measurement methodologies for technical performance is critical for consistent evaluation of image visualization on head mounted displays. Specifically, the procurement is for a spectroradiometer to precisely measure and evaluate the spectrum and color performance of image quality of augmented and virtual reality head mounted displays that are increasingly being incorporated in medical devices across the Office of Product Evaluation and Quality (OPEQ). The quantitative measurements from the spectroradiometer will allow for developing image quality regulatory science tools for a wider range image quality parameters across the full range of device types, opposed to only measuring luminance values. The specialized lens assembly on the spectroradiometer mimics the human visual system, which is critical for determining the image quality seen by the user. This will align the Office of Science and Engineering Laboratories (OSEL) instrumentation with FDA recognized standards, such as the International Electrotechnical Commission (IEC), for head mounted displays, which is essential for the OSEL mission of developing regulatory science tools. Minimum Performance Requirements: Item 1: Spectroradiometer Optical Specifications: • Wavelength range: at least 380-780 nm • Sensor size: at least 512 elements • Detector type for spectroradiometer: back-thinned and cooled CCD • Spectral resolution/Spectral bandwidth: < 5 nm, option for variable resolution preferable • Datapoint interval/Spectral reporting: 1 nm or less • Digital resolution: 16 bits Performance Specifications: • Wavelength accuracy: < 0.5 nm • Luminance accuracy: < +/- 3% • Integration time range: minimum 10 ms to 60 seconds • Stray light: less than 0.06% • Polarization error: less than 2% • Sensitivity: at least 5*10^-5 cd/m2 with a 2 degrees internal aperture measuring Illuminant A • Color accuracy (x,y): less than +/- 0.002 • Color repeatability (x,y): less than +/- 0.0005 Hardware Features • Variable internal aperture diameters: 2 degrees, 1 degree, and 0.1-0.25 degrees • Integrated neutral density filter: ND1 or ND2 • Communication: USB • Physical dimension: less than 20 cm x 36 cm x 36 cm • Weight: < 10 kg Item 2: Specialized lens for measuring near eye displays, including augmented and virtual reality displays The contractor shall provide a specialized lens optimized for measuring augmented reality (AR) and virtual reality (VR) displays with the following specifications: • Focal length: 30-50 mm • Front entrance pupil design with a fixed pupil with a diameter between 3 mm and 5 mm • Adjustable focus range: at least 300 mm to infinity • Luminance accuracy: < +/- 3% Item 3: Software The contractor shall provide software with the following capabilities: Core Functions: • Control spectroradiometer operations • Acquire measurements • Display spectrum and color measurements • Analyze measurement data Data Export: • Export raw data in Excel, ASCII, or equivalent formats Integration: • Software Development Kits (SDKs) or command line support for third-party software control • Compatible with Python and MATLAB • Compatible with Windows 10 Operating System or later versions • Compatible with Windows 10, Windows 11, or Linux Operating System Deliverables: The Contractor shall deliver the item and quantities ordered within 60 days of award. The Contractor shall deliver the following items and quantities ordered, all, or none: • Spectroradiometer system (Item 1) - fully calibrated and tested • Specialized lens for near-eye displays (Item 2) • Control and analysis software (Item 3) with installation media and documentation • Calibration certificate(s) or test report(s) • User manuals and technical documentation for all equipment • Software documentation including SDK/API documentation Place of Supply Delivery and Place of Performance: The equipment should be complete with all accessories and software necessary to work and to be delivered to: Attention: Yasaman Ardeshirpour U.S. Food and Drug Administration White Oak Building 62 Room 1112 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 Period of Performance: 12-month Base Year and Four, 12-month Option Years commencing upon date of award. Please see the attached Statement of Work and corresponding ancillary documents for review and consideration. Quotes are due by email on or before September 14, 2026, by 4:00 P.M. (Eastern Standard Time) and should be sent to brandon.rafus@fda.hhs.gov.

• NAICS334516
• PSC6640

• CDRH-2026-133605- SOW.pdf

  .pdf194 KBNot yet available
• Combined Synopsis Solicitation- CDRH-2026-133605- Final.pdf

  .pdf325 KBNot yet available

• Brandon Rafus
  brandon.rafus@fda.hhs.gov