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TN-Brush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets acceptance criteria for the "TN-Brush." The document is an FDA 510(k) clearance letter for the device, which primarily addresses its substantial equivalence to a predicate device and general regulatory compliance.

The document does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for any studies.
• The number or qualifications of experts used for ground truth.
• Adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for a training set.
• How ground truth for a training set was established.

The provided text focuses on the regulatory clearance process for a dental device (TN-Brush) and its indicated use for debridement of titanium dental implants. It does not delve into the specifics of performance studies or acceptance criteria that would fall under the scope of AI/ML device validation.

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