(184 days)
The DePuy Motech PEAK™ Anterior Compression Plate System is intended for use in the treatment of anterior cervical spine instability as a result of fractures, dislocations, subluxations, turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylosis or a previously failed cervical surgery.
The DePuy Motech PEAK™ Anterior Compression Plate System consists of 12 different Ti-6Al-4V plates. The plates are available in 4 design segments (1, 2, 3 or 4 "I" shaped segments), each being available in 3 lengths. The system also includes Ti-6A1-4V 3.5mm cortical and 4.0mm cancellous screws in 13 lengths.
This document describes a medical device, the DePuy Motech PEAK™ Anterior Compression Plate System, and its substantial equivalence to existing devices.
The provided text does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details) typically associated with a study proving a device meets acceptance criteria for an AI/ML or diagnostic device.
The document is a 510(k) summary for a spinal implant, focusing on its material, design, intended use, and mechanical testing to demonstrate equivalence to predicate devices. It states: "Mechanical testing indicates that the fatigue strength of the DePuy Motech PEAK™ Anterior Compression Plate is similar to that of the Acromed AcroPlate and is adequate for it's intended use."
This indicates that mechanical testing was performed to show equivalency in fatigue strength, which is a type of acceptance criterion for a physical implant. However, the exact acceptance criteria (e.g., minimum fatigue cycles or load) and the specific results from the DePuy Motech PEAK™ system or the predicate device are not reported in this summary.
Therefore, I cannot populate the requested table or answer the study-related questions based on the provided input. This K962486 summary is for a physical orthopedic implant, not a diagnostic or AI-driven device, which are typically associated with the kind of performance metrics and study designs in your prompt.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 2 7 1996
| NAME OF FIRM: | DePuy Inc.700 Orthopaedic DriveWarsaw, IN 46581-0988 |
|---|---|
| 510(K) CONTACT: | Cheryl HastingsManager, Clinical Affairs |
| TRADE NAME: | DePuy Motech PEAK™ Anterior Compression Plate System |
| COMMON NAME: | Anterior Cervical Plate |
| CLASSIFICATION: | 888.3060: Spinal intervertebral body fixation orthosis |
| PRODUCT CODE: | 87 KWQ |
| SUBSTANTIALLY | Acromed AcroPlate Anterior Cervical SystemEQUIVALENT DEVICES: Codman Anterior Cervical Plate SystemAesculap Caspar Cervical Plate |
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Motech PEAK™ Anterior Compression Plate System consists of 12 different Ti-6Al-4V plates. The plates are available in 4 design segments (1, 2, 3 or 4 "I" shaped segments), each being available in 3 lengths. The system also includes Ti-6A1-4V 3.5mm cortical and 4.0mm cancellous screws in 13 lengths.
The DePuy Motech PEAK™ Anterior Compression Plate System is intended for use in the treatment of anterior cervical spine instability as a result of fractures, dislocations, subluxations, turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylosis or a previously failed cervical surgery.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Motech PEAK™ Anterior Compression Plate System is similar in material, design and intended use to the Acromed AcroPlate Anterior Cervical System, the Codman Anterior Cervical Plate System and the Aesculap Cervical Plate System. All of these systems consist of Ti-6Al-4V or CP Titanium bone plates and screws intended for anterior stabilization of the cervical spine. Mechanical testing indicates that the fatigue strength of the DePuy Motech PEAK™ Anterior Compression Plate is similar to that of the Acromed AcroPlate and is adequate for it's intended use.
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