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• Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects)
• Restorations in deciduous teeth
• Intermediary restorations
• Anterior Class III restorations

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental material called "Compoglass Flow." This type of document does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

510(k) clearances establish substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. They typically rely on a comparison of characteristics and, sometimes, limited performance testing results to demonstrate that equivalence. They do not generally include comprehensive clinical trial data, detailed acceptance criteria for performance metrics, or information about ground truth establishment, sample sizes for training/test sets, or detailed expert qualifications that would be present in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot provide the requested information based on the given text.

To answer your request, I would need a detailed study report or a PMA application for the device, which would typically include:

• A clinical study protocol: Outlining the study design, endpoints, statistical analysis plan, and acceptance criteria.
• Clinical study report: Presenting the results of the study against the established acceptance criteria.
• Bench testing data: For certain performance characteristics.
• Ground truth establishment details: How the "truth" was determined for the performance evaluation.

Based on the available information, I can only state the following:

• Device Name: Compoglass Flow
• Indications for Use:
  • Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects)
  • Restorations in deciduous teeth
  • Intermediary restorations
  • Anterior Class III restorations
• Regulatory Class: II

The document essentially states that the FDA has determined the device is "substantially equivalent" to predicate devices for these indications, implying that its performance is considered acceptable relative to legally marketed devices. However, the specific performance metrics and their acceptance criteria are not detailed in this clearance letter.

Ask a specific question about this device