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The Monster BITE Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device

The Monster BITE Screw System™ includes snap-off, threaded bone screws offered in 2.0mm and 2.7mm diameters having overall lengths from 8 to 24mm.

Based on the provided FDA 510(k) summary, the device is the "Monster BITE Screw System™". This document is a premarket notification for a medical device and, as such, does not contain the detailed study data typically associated with clinical performance or AI algorithm validation.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving clinical efficacy or the device's ability to meet specific performance criteria through empirical studies with clinical endpoints like an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study data for performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable to this document because:

• This is a traditional medical device (metallic bone fixation fastener), not an AI/ML-driven device.
• The demonstration of substantial equivalence relies on material, design, and mechanical performance comparisons to predicate devices, not clinical performance metrics or AI algorithm accuracy.

The document does mention "Performance Data" but clarifies that it refers to theoretical comparisons of torsion and pullout strength along with insertion/removal torque testing per ASTM F543, demonstrating substantial mechanical equivalence to predicate devices, not clinical outcomes in patients or diagnostic accuracy.

In summary, the provided text does not contain the information needed to answer the prompt from the perspective of an AI/ML device's acceptance criteria and performance study because it describes a mechanical bone fixation device applying for 510(k) clearance based on substantial equivalence to existing devices.

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