Requirements Document SAM.docx

SOW

Statement of Work (SOW)

Imagine Eyes Deformable Mirror

Background The Government requires a deformable mirror (DM) that will be used in an adaptive optics (AO) system located in the Division of Biomedical Physics (DBP) AO laboratories under the Office of Science and Engineering Laboratories (OSEL) Ophthalmic Devices Program Charter. The requested optical component will support research aims that fulfill CDRH Strategic Priorities. The AO system provides a platform for developing and testing new regulatory science tools (methods, algorithms, biomarkers, phantoms, etc.) to achieve microscopic (cellular level) visualization of human retinal cells and structures during human subject and phantom investigations. In collaboration with leading academic institutions, these studies represent cutting-edge ophthalmic research focused on developing new performance assessment measures for medical devices. The required DM has a new design and performance measures that should further enhance the capabilities of the AO system.

Objectives The overall goal of the requirement is to obtain a DM with the minimum requirements listed under Requirements. The DM will be integrated as an optical component into the existing Government owned AO system.

Tasks The Contractor shall:

1. Manufacture and test the deformable mirror system per specifications

2. Provide factory calibration and quality assurance documentation

3. Deliver complete system with user documentation

4. Provide technical support and warranty services as specified

Requirements The Government requires a DM for use as an active optical component in an adaptive optics retinal imaging system with the following minimum requirements:

· Number of actuators (>90)

· Actuator layout (circular)

· Zernike orders corrected (up to 10)

· Coating and reflectivity (silver, >95%)

· Effective diameter (15 mm)

· Surface quality (<10 nm RMS)

· Stroke (±50 µm)

· AR coated window in front of mirror for protection

· Driver electronics and computer interface (no external hardware required, prefer USB3 interface)

Additional Requirements User manual: The Contractor shall provide a comprehensive user manual that includes detailed instructions for device operation, maintenance procedures, troubleshooting guidance, safety warnings, and complete performance specifications with operating parameters.

Warranty: The Contractor shall provide a minimum one (1) year warranty from date of Government acceptance of the DM. 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.

Shipping: All proposed prices must include shipping, handling, insurance, and customs clearance costs. The contractor is responsible for all costs associated with delivery to the specified destination and shall handle all customs documentation and clearance procedures for international shipments.

Acceptance/Testing: The Government will visually inspect the DM to verify it meets all structural requirements. Other dynamic requirements (stroke, Zernike orders corrected) will be tested in the government laboratory using a commercial wavefront sensor. Reflectivity at certain wavelengths will also be tested with optical sources and detectors. All acceptance testing will be performed by Government personal.

Deliverables The Contractor shall provide the following items within 30 days of contract award:

1. DM System: Complete device as specified, factory-tested and calibrated, with all necessary components for immediate operation

2. User Manual: Comprehensive documentation including installation procedures, operating instructions, maintenance guidelines, troubleshooting protocols, safety warnings, and complete performance specifications

3. Technical Support: One (1) year of technical support from delivery date, including phone and email assistance during normal business hours (8:00 AM - 5:00 PM ET, Monday-Friday, excluding federal holidays)

4. Warranty: One (1) year manufacturer warranty covering full replacement at no cost for manufacturing defects or operational failures during normal use

Delivery Requirements All shipping, handling, insurance, and customs clearance costs are the Contractor's responsibility. The Contractor shall handle all documentation and procedures for US customs clearance. The Contractor shall deliver the DM within 30 days of contract award. The Contractor shall provide tracking information and delivery confirmation.

Delivery Address:

TBD

FDA

Silver Spring, MD 20993

Place of Performance Manufacturing and testing may be performed at the Contractor's facility. Delivery must be made to address specified in the Delivery Requirements section.

Period of Performance Period of performance shall be 30 days from contract award through completion of delivery and acceptance by the Government. The Contractor shall provide one (1) year manufacturer warranty.

BASIS FOR EVALUATION: Lowest price technically acceptable