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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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The DePuy Motech PEAK Fixation System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus and metatarsals and in treating fractures of the lateral malleolus, olecranon, and intra-articular distal tibia.

The system consists of 5 sizes of channeled reconstruction plates ranging from 26mm to 104mm in length, 13 sizes of 3.5mm cortical screws ranging from 16 to 30mm in length and a steplock washer. The reconstruction plates are 3mm thick and 9mm wide. All plates incorporate a tooth pattern, on one outer surface. The teeth are designed to interlock with the "tabs" on the steplock washer.

This 510(k) summary describes a medical device, the DePuy Motech PEAK Fixation System, and its substantial equivalence to predicate devices, but does not contain any information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested.

The provided text focuses on:

• Device Description and Intended Use: Explaining what the device is, what it's used for, and its components.
• Basis of Substantial Equivalence: Comparing its materials, design, and intended use to existing devices.
• Mechanical Testing: A statement that its mechanical properties (rigidity, strength, stiffness in 4-point bending) exceed those of predicate devices.

However, it lacks the specific details required to answer your questions about acceptance criteria, clinical study methodology, expert involvement, and ground truth establishment. This type of information is typically found in detailed study reports, clinical trial summaries, or more extensive sections of a 510(k) submission, which are not present in the provided excerpt.

Therefore, I cannot populate the table or answer the subsequent questions based solely on the input provided. The summary only mentions "mechanical testing shows that..." without describing the acceptance criteria for that testing or the full study details.

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