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The Nobelpharma BRÅNEMARK SYSTEM - MK II Self-Tapping Fixtures are intended to be used in edentulous and partially edentulous patients to restore chewing functions.

The Nobelpharma BRÅNEMARK SYSTEM - Mk II Self-Tapping Fixture is a line of endosseous implants, varying in diameter, which are implanted in the upper and lower jaw bone to be used to support prosthetic devices to help restore chewing functions of edentulous patients. The device has been cleared for sizes 3.75, 4.0, 4.4, 5.0 and 5.5mm diameters. The only modification is to the 5.0 and 5.5mm diameter fixtures. This modification of the 5.0mm and 5.5mm diameter fixtures entails 1) an increased internal thread diameter for insertion of appropriate abutment screws and 2) an increased hexagonal dimension for the hex portion of the fixture to facilitate accurate seating of appropriate abutments. An additional minor modification to the flange (a 0.4mm increase of diameter) and to the apex (a 0.3mm increase in diameter) is being made to the 5.5mm fixture to accommodate the surgical and prosthetic components of the system.

This request cannot be fulfilled. The provided text describes a medical device (an endosseous implant) and its specifications, but it does not contain information about acceptance criteria, device performance studies, or AI/software validation. The document is a 510(k) summary from 1996 for a physical implant device, not a diagnostic or AI-powered medical device that would involve the type of study details you're asking for.

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