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The Brånemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Brånemark System implant products that are the subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, either machined or modified (TiUnite) surface, and are already commercially available.

The provided text describes a 510(k) summary for various Brånemark System Dental Implant Products, specifically regarding an expanded indication for immediate function. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically seen in submissions for AI/ML-enabled devices.

The submission is for a medical device (dental implants) where the technological characteristics are stated to remain "substantially unchanged" and "no design modifications were made that effect safety and effectiveness." The "Performance Data" section merely states: "Clinical results show that the expanded Indications for Use are as safe and effective as the original Indications for Use." This is a general statement and does not provide specific acceptance criteria or detailed study results.

Therefore, for your request, I must report that the provided text does not contain the requested information regarding acceptance criteria and a study proving a device meets those criteria.

The document is a 510(k) summary focusing on the equivalence of an expanded indication for use for dental implants, not a detailed performance study for a new or modified device with specific acceptance metrics. The questions you've asked are typically relevant for AI/ML-driven devices or those with quantifiable performance metrics that need to be demonstrated against pre-defined acceptance criteria. This document doesn't fall into that category.

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