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The 5.0 x 6.0mm locking-taper Bicon dental implant is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore the patient's chewing function.

The 5.0 x 6.0mm Dental Implant

I am sorry, but the provided text is a 510(k) clearance letter for a dental implant and does not contain the information requested regarding acceptance criteria, device performance studies, or details about AI algorithms. This document is a regulatory approval letter, not a technical study report.

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The 5.0 x 6.0mm Bicon dental implant is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore the patient's chewing function.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for a dental implant.

It informs Dr. Vincent Morgan that their device, "The 5.0 x 6.0mm Dental Implant," has been found substantially equivalent to a legally marketed predicate device. This letter approves the marketing of the device, but it does not include the underlying study data, acceptance criteria, or performance metrics.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Details about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Results of standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This FDA letter is a regulatory approval document based on a review of submitted information, not a publication of the study data itself.

Ask a specific question about this device