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Magnacap is a magnetic abutment for implant retained dental and craniofacial prosthesis and root supported overdentures. Magnacap is engineered to fit several commercially available implant fixtures.

Magnacap is a magnetic abutment for implant retained dental and craniofacial prosthesis and root supported overdentures. Magnacap is engineered to fit several commercially available implant fixtures.

This looks like an FDA 510(k) clearance letter for a dental device called "Magnacap." It's a regulatory document and does not contain the kind of detailed study information you're asking for.

Specifically, the document does not contain any of the following information:

• A table of acceptance criteria and reported device performance
• Sample sizes used for test or training sets
• Data provenance (country of origin, retrospective/prospective)
• Number or qualifications of experts for ground truth
• Adjudication method for the test set
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study
• Results of a standalone (algorithm only) performance study
• Type of ground truth used (expert consensus, pathology, outcomes data)
• How ground truth for the training set was established

This document primarily states that the FDA has reviewed the 510(k) submission for the Magnacap device and determined it is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general regulatory requirements but does not delve into the specifics of performance testing or clinical studies.

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