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VELscope is to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities by exciting the tissue with blue light and allowing the direct visualization of the resulting natural tissue fluorescence. VELscope is complimentary to and is intended to be used in combination with a traditional oral mucosal examination with white light.

VELscope is intended to be used by a dentist or heatth-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities.

VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.

The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.

It appears that the provided text is a 510(k) summary for the VELscope device, which focuses on demonstrating substantial equivalence to a predicate device (Vizilite) rather than a direct study proving specific acceptance criteria for the new device. As such, many of the requested data points for a clinical or performance study proving acceptance criteria are not present in this document.

However, I can extract the information that is available and highlight what is not provided based on the context of a 510(k) summary.

Analysis of the Provided Text for Acceptance Criteria and Study Details:

The 510(k) summary for VELscope (K060920) explicitly states that the device is "substantially equivalent to Vizilite" and details the similarities and minor differences. It does not provide a standalone study with defined acceptance criteria for the VELscope itself. Instead, it relies on the predicate device's existing market clearance.

The document mentions: "NIH funded scientific studies provide evidence to support that VELscope is effective in enhancing the visualization of oral mucosal abnormalities." However, it does not provide details about these studies, their design, or their specific findings in the context of acceptance criteria for the VELscope device.

Therefore, for many of your specific requests (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details for training/test sets), the information is not available in this 510(k) summary. These details would typically be found in a separate clinical study report or a more detailed performance evaluation document that a 510(k) summary often references but doesn't fully reproduce.

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

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information from the Provided Text:

2. 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 mentions "NIH funded scientific studies" but doesn't detail their methodology, sample size, or data provenance.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 provided. This device is an adjunctive light system, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. VELscope is a direct visualization system intended to be used by a human practitioner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device with a distinct "training set" in that sense. The efficacy relies on bio-fluorescence properties of tissue.
9. How the ground truth for the training set was established: Not applicable.

Summary of Study (as per the 510(k) document):

The 510(k) for VELscope relies on establishing substantial equivalence to the predicate device, Vizilite, and general statements about "NIH funded scientific studies" supporting its effectiveness. It does not present a detailed, standalone clinical study with specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies for the VELscope device itself within this document. The FDA's letter confirms substantial equivalence based on the provided information, allowing it to market the device.

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