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The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam.

INDICATIONS FOR USE: The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

The provided document, K080043, is a 510(k) summary for ViziLite Eyewear, indicating FDA clearance based on substantial equivalence to a predicate device. This type of submission focuses on demonstrating equivalence rather than comprehensive clinical efficacy studies with predefined acceptance criteria. Therefore, the document does NOT contain the detailed information requested in the prompt regarding acceptance criteria, extensive clinical trial data, or detailed ground truth methodologies that would typically be found in a PMA (Premarket Approval) submission or a more rigorous clinical study report.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly define quantitative acceptance criteria or report specific device performance metrics in the format of a table as typically seen in efficacy studies. The "performance" described is in the context of its intended use to reduce ambient light effects.

The eyewear is designed to "allow transmission of 430-580nm light," which aligns with the chemiluminescent light source (ViziLite) it's designed to be used with. The functional performance is that it enables the procedure to be performed effectively without a darkened room. |
| Secondary: Not altering safety and efficacy of the ViziLite Plus with TBlue procedure. | "without altering safety and efficacy." |
| Functional: Allows transmission of light in the 430-580nm range. | "The ViziLite Eyewear has been designed to allow transmission of 430-580nm light." |

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

• The document explicitly mentions "clinical testing" in the "Instructions for Use" section but does not provide details about the sample size (number of patients or cases) of the test set.
• Data provenance (e.g., country of origin, retrospective or prospective) is not specified.

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

• The document does not provide any information on the number of experts used or their qualifications to establish ground truth for any test set. The phrase "trained health care professional" is used in the instructions for use, implying clinical judgment, but no details on expert panels for ground truth determination are given.

4. Adjudication method for the test set

• The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

• No MRMC comparative effectiveness study is mentioned. The device is an optical filter (eyewear), not an AI-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The comparison is between performing the ViziLite procedure with the eyewear vs. requiring a darkened room, and maintaining diagnostic performance.

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

• This question is not applicable as the ViziLite Eyewear is a passive optical filter designed for human use, not a standalone algorithm.

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

• The document does not explicitly state the type of ground truth used for its "clinical testing." Given the context of oral lesion identification, clinical assessment and possibly biopsy/histopathology would be the typical ground truth in such evaluations, but this is not detailed.

8. The sample size for the training set

• The document does not mention a training set sample size. As this is a 510(k) for an optical accessory, a "training set" in the machine learning sense is not applicable. If "training set" refers to data used to initially establish the eyewear's specifications or demonstrate its function, those details are not provided.

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

• This question is also not applicable for the same reasons as point 8.

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