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The SpectraVu Family of Intracral Cameras are intended for use in dentistry to provide a view of the oral cavity and contents as an aid in explaining and demonstrating conditions to patients. These also provide an enlarged view of areas for the dentist to better identify defects. Images can be stored for future reference.

These cameras are not intended for use as an operative device. The camera and components are not manufactured to be sterile, however the metallic sleeve tip with the glass optical window is designed to be sterilized between uses, and/or may be protected by commercially available plastic disposable sleeves,

The SpectraVu Family of Intraoral Camera Systems . consist of a power supply, digital camera processor, circuit boards, a light source, optical and electronic cables, and an ergonomic hand piece with an autoclavable sleeve containing an optical system. The components are capable of capturing images over a wide focal range. The images can be displayed on a television monitor, in a computer or may be printed out.

The provided text is a 510(k) summary for the SpectraVu Family of Intraoral Camera Systems. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria and detailed quantitative metrics.

Here's an analysis based on the provided text, focusing on the requested information where available, and noting what is not explicitly stated in this document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define explicit quantitative acceptance criteria or report specific performance metrics from a dedicated study. Instead, it relies on demonstrating technological similarities and intended use equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

Not mentioned. The document does not describe a test set or clinical study with a specified sample size. The 510(k) focuses on a comparison of technical features rather than a performance study involving a subject cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not mentioned. Since no explicit test set or ground truth establishment is described for a performance study, this information is not available.

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

Not mentioned. No adjudication method is described as there is no mention of a performance study requiring ground truth adjudication.

5. 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

Not applicable. This device (an intraoral camera) is not an AI-powered device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed. The submission focuses on the camera's ability to capture and display images for patient education and defect identification.

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

Not applicable. This device is a hardware imaging system, not an algorithm. Its function inherently involves a human operator (the dentist) to capture and interpret images. There is no standalone "algorithm only" performance to be evaluated.

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

Not explicitly described in the context of a performance study. The "ground truth" for this device, based on its intended use, would implicitly be the actual oral cavity conditions that the camera is intended to visualize and aid in identifying. The submission demonstrates that the camera's technical specifications and features (like high-resolution and accurate color imaging) are suitable for this purpose, but it doesn't detail a formal process for establishing a "ground truth" for a study.

8. The sample size for the training set

Not applicable/Not mentioned. This is a hardware device; there is no "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established

Not applicable/Not mentioned. As there's no training set, this information is irrelevant.

In summary:

This 510(k) submission primarily relies on a comparison of technological features and intended use to demonstrate substantial equivalence to a legally marketed predicate device (UltraCam II). It does not describe a clinical performance study with predefined acceptance criteria, test sets, ground truth establishment, or expert evaluations in the manner typically seen for more complex diagnostic or AI-driven devices. The "reported device performance" is mainly a qualitative assertion of its capabilities as they match the predicate, such as "High resolution image" and "Accurate color image".

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