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The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.

The subject devices consist of a Transverse Connector Hook used to connect the 3mm rods at right angles or transversely across the fracture: an Inner Screw used to hold the rods and hook connectors together; and the Transverse Connector Assembly that consists of the subject Transverse Hook Connector, subject Inner Set Screw, and the predicate 3mm Fixation Rod (K980368).

The provided text is a 510(k) summary for the DePuy Motech PEAK™ Fixation System, which is a medical device for bone fixation. It details the device's intended use, materials, and substantial equivalence to existing devices. However, this document does not describe a study involving device performance metrics, acceptance criteria, or ground truth establishment for an AI/algorithm-based device.

Instead, it's a regulatory document for a physical bone fixation appliance, focusing on its mechanical equivalence and intended use compared to predicate devices. Therefore, I cannot generate the requested information based on the input text.

The information requested, such as acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are typically relevant for the evaluation of AI/Machine Learning-based medical devices, especially those that generate diagnostic or prognostic outputs. The provided document is for a mechanical orthopedic implant.

To provide the requested table and study details, I would need a document describing the testing and validation of an AI-powered device.

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