Statement of Need.docx

STATEMENT OF NEED

1. GENERAL: The Dermatology Laser Department at James A. Haley Veterans’ Hospital, 12210 Bruce B. Downs Blvd, Tampa, FL 33612, has the need for a DAMAE Medical Video Dermoscope.

2. BACKGROUND: The Dermatology Laser Department at James A. Haley Veterans’ Hospital, 12210 Bruce B. Downs Blvd, Tampa, FL 33612 treats various skin disorders with lights, lasers, and energy-based devices. We currently own and use the DAMAE Medical Deep Live Imaging Medical Device that uses LC-OCT (Line-field Confocal Optical Coherence Tomography) for 3D imaging. The DAMAE Medical Video Dermoscope is a highly specialized addition to this imaging system that provides a unique 3D modality that allows histology-like vertical mode to a confocal-like horizontal mode, and to record a 3D stack of tissue volumes that provides medical specialists an unmatched visual representation of the scanned tissues distinctly representative of its whole origin. This technology will allow for better care of Veterans, expanding services offered here at the clinic to include managing and monitoring multiple skin conditions to include early detection of various skin cancers.

3. PURPOSE: The Damae Medical Video Dermoscope with AI assistant will improve patient experience by affording a versatile device with customizable assessments. This Video Dermoscope Imaging Medical Device will equip the dermatology clinic with advanced, specialized technology that enhances patient care by enabling high‑quality imaging of multiple skin conditions and supporting efficient, reassuring, and noninvasive patient management. This equipment and technology will significantly improve the clinic's ability to provide comprehensive, state-of-the-art dermatological care for veterans. The digital imaging and diagnostic support system will allow for more accurate diagnosis and monitoring of skin conditions. Implementation of the DAMAE Medical Video Dermoscope at James Haley Veterans’ Hospital will provide workflow efficiency as the time will be drastically decreased with the ability to use the best-in-class solution pairing penetration and resolution in 3D. The Dermatology department will realize improved patient care through the most advanced diagnostic equipment which can be lifesaving and life changing in the earlier identification of conditions that could otherwise be fatal. The advancements in diagnosis will also ultimately lead to improved scheduling capability/flexibility creating a safer, more reliable and more productive healthcare experience which is paramount in such an extremely specialized field of limited personnel.

4. SCOPE: James a Haley is requesting to procure one (1) DAMAE Medical Video Dermoscope for the Dermatology Laser Clinic.

5. SALIENT CHARCTERISTICS: DAMAE Medical Video Dermoscope + AI-Assistant software

a. Functional Characteristics: Device must integrate and work with the DAMAE Medical Deep Live Imaging Medical Device that uses LC-OCT (Line-field Confocal Optical Coherence Tomography) for 3D imaging. It must completely integrate with the AI diagnostic and differential diagnosis support as part of the entire DeepLive system.

b. DMS IMAGING CHARACTERISTICS

i. Intergated DMS Light: White emissions LEDs- Risk group 0 according to EN 62471 standard

ii. Optical Resolution: < 4um

iii. Field of view: 1.4 x 0.9cm2

iv. Frame rate: 10FPS

c. DMS PROBE

i. Hand held Device

ii. Ability to capture and switch polarization mode

iii. Plastic casing that protects technical component system

iv. Unambiguous grip compatible with right and left handed

6. INSTALLATION: The Dermoscope to be received at the Dermatology Laser Clinic for installation. Installation will occur during normal business hours. Installation must be coordinated with VA point of contact prior to beginning. Installation will be an accessory component to the DAMAE Medical Deep Live Imaging Medical Device that is currently in use. No Electrical or Data Modifications will be needed. This device does not connect to the VA connections.

7. DELIVERY SCHEDULE: Product to be delivered within 30 calendar days after receipt of order (ARO). Implementation Training to be conducted following product delivery.

8. PLACE OF DELIVERY: James A. Haley Veterans Hospital Dermatology Clinic 12210 Bruce B. Downs Blvd, Tampa, FL 33612.