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The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Impact PEEK Union Nail System." This letter details the administrative aspects of the clearance, including the device name, manufacturer, regulatory classification, and the FDA's determination of substantial equivalence to predicate devices.

However, it does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for software-based or AI/ML-driven medical devices.

The document specifically states:

• "No FDA performance standards have been established for the Impact PEEK Union Nail System."
• The non-clinical testing performed includes "Static and Dynamic Bending, Axial Pullout (ASTM F1264-16, ASTM F543-17)" and "Shear Testing (ASTM D2344)." These are mechanical and material property tests common for orthopedic implants, not studies designed to assess the performance of a software algorithm or AI model in an clinical setting.
• The "Equivalence to Predicate Devices" section emphasizes "similar design and similar dimensions," manufacturing material (HA Enhanced PEEK), "same intended use," and "similar technological characteristics," all referring to the physical implant rather than computational performance.

Therefore, I cannot extract the requested information from this document because it pertains to a physical orthopedic implant, not an AI/ML or software-driven medical device. The questions you've asked (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance) are highly relevant to the validation of AI/ML medical devices but are not applicable to the type of device described in this 510(k) clearance letter.

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