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Straumann® temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Straumann® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges.

Straumann® BLX Temporary Abutments PMMA are temporary abutments intended for placement on Straumann BLX Dental Implants with RB/WB and WB connection platforms. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy (TAN) inlay.

The provided text is a 510(k) Summary for a medical device (Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA). It outlines the device description, indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-enabled medical device performance study.

Specifically, the document focuses on the physical and material properties, and mechanical performance testing (dynamic fatigue and static strength) of a dental implant abutment, rather than the performance of a software or AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and establishment for training/test sets, training set sample size) from this document as it pertains to an AI/ML device study.

The "Performance Testing" section (5.7) mentions:

• "Dynamic fatigue and static strength tests were conducted according to the FDA guidance document 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments' and demonstrated the BLX Temporary Abutments PMMA performed as well as the reference devices."
• This refers to physical testing of the device's durability and strength, not AI/ML performance.

The "Conclusion" (5.8) states that the device is "substantially equivalent to the legally marketed primary predicate and reference devices" based on nonclinical tests (which would include the mechanical and material tests mentioned).

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and study details for an AI/ML-enabled medical device.

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