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The devices are intended to treat fractures of various bones, including the clavicle, scapyla, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).

All app bone plates and screws are for single use only and are not intended for any spinal fixation procedures.

The aap bone plate and screw implants are used for internal fixation of long and small bones. The plates are manufactured from commercial pure Titanium or Stainless Steel and the screws are manufactured from Titanium alloy or Stainless Steel.

The provided text is a 510(k) summary for a medical device (aap Bone Plate and Screw Implants) and does not describe acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving such a device meets acceptance criteria.

The document focuses on:

• Identification of the device: Trade name, common name, classification, product code.
• Submitter and Contact Information: Company details.
• Performance Standards: References to cGMPs, ASTM requirements, and harmonized standards (ISO 13485:2003) for manufacturing and material specifications (Titanium, 316L Stainless Steel).
• Intended Use: Description of fracture types and bones the implants are designed to treat, referencing AO Foundation principles.
• Contraindications: Specific conditions where the device should not be used.
• Device Description: Detailed list of various bone plates and screws with their dimensions and materials.
• Predicate Devices: Comparison to other legally marketed bone plate and screw implants to establish substantial equivalence.
• Sterilization Information: Instructions for end-user sterilization.
• FDA Communication: Official letter from the FDA affirming the substantial equivalence and permitting marketing of the device.
• Indications for Use Statement: Formal statement mirroring the intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies, as this information is not present in the provided text. The document pertains to traditional medical device clearance based on substantial equivalence, not AI/algorithm performance.

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