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Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external on prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).

The device 'Osseointegrated Fixtures' refers to a system involving endosseous implants and their accessories. The endosseous implants are solid, screw-type, self-tapping implants made from commercially pure titanium, with the same enhanced surface as the Southern Implants dental implants. The accessories include drills to prepare the site, abutments and attachments to aid the prosthetic retention, placement tools, instruments and laboratory components.

I'm sorry, but relevant information for answering your request is not provided in the document. The document describes a 510(k) premarket notification for an osseointegrated fixture, and it focuses on demonstrating substantial equivalence to predicate devices rather than outlining specific acceptance criteria, study details, or performance metrics of the new device. It lists standards for safety testing but does not present the results or how they demonstrate meeting acceptance criteria.

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