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The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).

Kodak's Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).

This document, a 510(k) summary for the KODAK Digital Science Film Digitizer L7501/L7506, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert involvement, or sample sizes typically found in performance studies for diagnostic algorithms.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, expert involvement, ground truth, and sample sizes based solely on the provided text.

The document discusses:

• Device Name: KODAK Digital Science Film Digitizer L7501 / L7506
• Intended Use: Converting X-ray films into digital images for display, transmission, and/or archiving within a PACS, facilitating remote consultations and faster image recall.
• Predicate Device: KODAK Film Digitizer ("FD")
• Substantial Equivalence: Claimed based on similar purpose, functionality, and image clarity/definition compared to the predicate device (Vortech (Kodak) FD system K915362). The main difference mentioned is hardware choice and some updates in patient information entry and networking standards (DICOM for KDS FD vs. ACR-NEMA 2.0 for FD).

To fulfill the request, a different type of document (e.g., a detailed performance study report or clinical validation report) would be needed.

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