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Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the detection and diagnosis of dental caries.

The Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain any explicit acceptance criteria or reported device performance metrics from a clinical study. It only states that "Clinical testing was performed and established the effectiveness of the device to its claims."

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not specified in the provided document.

4. Adjudication Method:

Not specified in the provided document.

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

Not mentioned or described in the provided document. Therefore, no effect size of human reader improvement with AI assistance can be reported.

6. Standalone Performance Study:

A standalone performance study of the algorithm (without human-in-the-loop performance) is not explicitly mentioned or described. The document refers to "the effectiveness of the device," which, given the device description as an "aid," implies human involvement.

7. Type of Ground Truth Used:

Not specified in the provided document.

8. Sample Size for the Training Set:

Not specified in the provided document.

9. How the Ground Truth for the Training Set Was Established:

Not specified in the provided document.

Summary of what is available in the document:

The provided 510(k) summary (K090169) for the Spectra Fluorescence Caries Detection Aid System focuses primarily on regulatory compliance and substantial equivalence to a predicate device (Inspektor Pro K040063). While it states that clinical testing was performed to establish effectiveness, it lacks any detailed information about the methodology, results, acceptance criteria, or specific performance metrics of that study. This means that nearly all the specific information requested in your prompt regarding acceptance criteria and study details is not present in the provided text.

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