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The Kodak 1500 Intraoral Camera is intended for chairside use by dentists and dental sub-specialists during oral health examinations. It provides magnified digital color images of intraoral or extraoral anatomy via a video monitor or Personal Computer (PC). Both still and video images can be captured and stored. The device allows practitioners to view the interior of the oral cavity and assist in the assessment of the overall oral health of the patient. The Kodak 1500 also provides a tool for communicating treatment requirements or results by allowing practitioner and patient to view areas of concern together, before and after procedures.

The Kodak 1500 Intraoral Camera is indicated for use by health professionals in viewing and capturing intraoral or extraoral color video images for the purposes of:

1. Allowing practitioners to view and magnify regions of the oral cavity

2. Assisting communications with the patient by providing a view of treatment areas before and after a procedure

3. Providing images for documentation in patient records.

The Kodak 1500 includes a camera/handpiece assembly, docking station, and embedded acquisition software. It is available in two versions: Kodak 1500 Intraoral Camera – wired and Kodak 1500 Intraoral Camera – wireless. The wireless version, in which the handpiece transmits the acquired image data to the docking station via Wi-Fi, also includes a charging station. Users may use the system with only a chairside video monitor, or may connect it to a PC. The camera/handpiece includes illumination via eight white-light LEDs.

The Kodak 1500 Intraoral Camera 510(k) summary does not include specific acceptance criteria or an explicit study proving performance against such criteria. The document focuses on establishing substantial equivalence to predicate devices and detailing non-clinical testing.

Here's an analysis of what information is present and what is missing based on your requested format:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The document states "Bench top performance testing... was performed on Hardware sub-systems, Software sub-systems, and on the complete assembled device" and "The system also has undergone laboratory testing for mechanical, electrical, and EMC/EMI." However, no details on test sample sizes (e.g., number of images, number of test cases, duration of tests) or data provenance are mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not provided. The document does not describe any human-observer-based ground truth establishment for performance testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. No human-observer studies or ground truthing methods involving adjudication are described.

4. 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, an MRMC study was not done/reported. The device is an intraoral camera, not an AI-powered diagnostic tool, so this type of study would not be expected in this context.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable/Not explicitly stated. The device is a camera. Its "performance" would relate to image quality, functionality (wired/wireless), and other technical specifications, not an "algorithm only" diagnostic output. The non-clinical testing likely evaluated these aspects in a standalone manner (e.g., camera's image capture capabilities, wireless transmission reliability).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated for image-related performance. For the non-clinical testing mentioned (hardware, software, mechanical, electrical, EMC/EMI), the "ground truth" would be engineering specifications and regulatory standards. For image quality, it would likely involve objective metrics or comparison to established reference images, but this is not detailed.

7. The sample size for the training set:

   • Not applicable. This device is a camera, not an AI model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This device is a camera, not an AI model.

Summary of Device and Approval:

The Kodak 1500 Intraoral Camera's 510(k) summary focuses on establishing substantial equivalence to existing predicate devices (Gendex AcuCam Concept IV and STV Pro 2) based on intended use, technological characteristics, principles of operation, intended users, energy use, materials, biocompatibility, labeling, workflow, and other relevant characteristics.

The "Non-clinical Testing" section states that "Bench top performance testing of the Kodak 1500 was performed on Hardware sub-systems, Software sub-systems, and on the complete assembled device. The system also has undergone laboratory testing for mechanical, electrical, and EMC/EMI." The conclusion drawn from this testing is that "Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use." This is a general statement of compliance, not a detailed presentation of specific performance metrics against an acceptance criterion.

This type of submission is common for Class I devices like intraoral cameras, where the primary concern is safety and effectiveness based on established technology and substantial equivalence to legally marketed devices, rather than novel diagnostic performance.

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