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Korlex-GRTM is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures when sulcus widening is needed.

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The provided text is a 510(k) premarket notification letter from the FDA to Biotech One, Incorporated, regarding their device Korlex-GR™. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for the detailed table and study information based on this input. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also outlines general regulatory compliance requirements.

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The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

BONAMATES® Series

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the BONAMATES® Series, which are bone plates. It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

The document includes:

• The device name: BONAMATES® Series.
• The regulation number and name: 872.4760, Bone Plate.
• The product code: JEY.
• Indications for Use: Trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance).
• Information on how ground truth was established for training or testing sets.

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

Ask a specific question about this device