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The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.

The Progeny, Inc. Vivid Intraoral Video Camera is a state-of-the-art dental video camera. When used with a compatible software application, the operator will be able to capture and store video images into a patient's file.

The provided text describes the Progeny Inc. Vivid Intraoral Camera System and its 510(k) submission (K090079) but does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Gendex EZ CAM and Schick USB CAM) by comparing characteristics and stating that "Performance testing and verification to meet product specifications" was performed. There's no detailed study report or specific performance metrics mentioned that would constitute "acceptance criteria."

However, I can extract the available information and present it in the requested format, highlighting what is implicitly or explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not defined with numerical targets in the provided document, I will infer the implicitly accepted performance based on the comparison to predicate devices, which serves as the basis for substantial equivalence. The "Reported Device Performance" for the Progeny Vivid Camera is its ability to match or be within the range of the predicate devices' characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify any sample size for a test set used to evaluate the device. The evaluation appears to be based on "Performance testing and verification to meet product specifications" and comparison of technical characteristics, rather than a clinical or user study with a defined test set. Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The submission focuses on technical specifications and substantial equivalence, not on expert-adjudicated ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided as no specific test set or associated adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or described in the provided text. The document does not mention any studies involving human readers or AI assistance, nor does it discuss an effect size for human improvement with AI.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on an algorithm's performance without human-in-the-loop was not conducted or described. The device is an intraoral video camera, not an AI algorithm, and its performance is evaluated based on its functional characteristics.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/performance studies (e.g., expert consensus, pathology, outcome data) is not applicable or mentioned in this submission. The evaluation is based on verifying that the camera's technical specifications and functional features are comparable to the predicate devices.

8. Sample Size for the Training Set

The document does not mention a training set. This device is an imaging hardware component, not an AI/machine learning algorithm that would typically require a training set.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, there is no information on how its ground truth would have been established.

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