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The implant(s) is designed for use in the edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed or partial dentures, or a single tooth replacement.

Various Dental Implants

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for "Various Dental Implants," confirming their substantial equivalence to previously marketed devices.

This type of document typically focuses on regulatory clearance based on substantial equivalence, rather than detailing the specific performance studies and acceptance criteria that would have been submitted by the manufacturer as part of their 510(k) application.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Information about an MRMC comparative effectiveness study or effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The letter only states that the FDA "reviewed your Section 510(k) notification of intent to market the device... and we have determined the device is substantially equivalent... to legally marketed predicate devices." It also lists the "Indications For Use."

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