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Intended uses in the dental industry include the following:

• Radiograph viewing and manipulation for insurance claims adjudication. .
• Radiograph viewing and manipulation for diagnostic purposes ●
• Radiograph viewing for patient education and consultation. .

When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.

The KODAK DIGITAL SCIENCE™ Dental Image Viewer is a software package designed to provide full resolution digitized images of a dental x-ray film for diagnostic review, insurance adjudication and patient consultation. The KODAK DIGITAL SCIENCE™ Dental Image Viewer is designed to operate on a standard PC-compatible computer.

KODAK DIGITAL SCIENCE™ Dental Image Viewer features the display of full-mouth sets and other mounts, high-resolution image display and manipulation, and interfaces with practice management systems.

The provided text is a 510(k) summary for the KODAK DIGITAL SCIENCE™ Dental Image Viewer. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, or clinical validations.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and the reported device performance: This information is not present in the document. The submission focuses on substantial equivalence based on functional and technical specifications, not performance against specific acceptance criteria.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned.
• Adjudication method for the test set: No test set or adjudication is mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study is described. The device is an image viewer and manipulation tool, not primarily an AI-assisted diagnostic tool in the modern sense.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is mentioned.
• The type of ground truth used: No specific ground truth is mentioned in relation to performance studies.
• The sample size for the training set: No training set is mentioned as this device predates widespread machine learning applications in medical imaging.
• How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TAU Corporation TigerScan/TigerView) by comparing technical and functional specifications. It does not include data from performance studies or clinical trials that would typically establish acceptance criteria and verify device performance against them.

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