(178 days)
The DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is intended for anterior cervical screw fixation in the treatment of anterior cervical spine instability as a result of fractures (dislocations and subluxations), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), or a failed previous cervical spine surgery.
The DePuy Motech PEAK Polyaxial Anterior Cervical Plate System consists of 30 different Ti-6Al-4V ELI plates. The plates are available in 4 design segments (1, 2, 3 or 4 "I shaped" segments), each being available in a variety of lengths. The system also includes 3 different Ti-6Al-4V ELI cancellous screws. The 4.0mm screw is utilized in the plate holes which are located around the periphery of the plate and are intended for fixation between the plate and vertebral bodies that have been spanned by the construct. The 4.35mm screws are intended for use in the same manner as the 4.0mm screws. The 4.35mm bone screw is intended to be used in the event that the surgeon must remove and reinsert a 4.0mm bone screw. The 4.35mm bone screw is larger and therefore would allow a surgeon to regain purchase in the previous screw hole. The graft screw is optionally used in the case of a corpectomy and subsequent replacement with a strut graft, to obtain fixation between the graft and plate.
The provided 510(k) summary for the DePuy Motech PEAK™ Polyaxial Anterior Cervical Plate System focuses on demonstrating substantial equivalence through material, design, and intended use comparison to a predicate device, as well as mechanical fatigue testing. It does not include information about a study involving performance metrics like accuracy, sensitivity, or specificity for a software-driven device, nor does it describe human reader studies.
Therefore, many of the requested sections below cannot be populated from the provided text.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance Study for DePuy Motech PEAK™ Polyaxial Anterior Cervical Plate System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Fatigue Strength (specifically, in comparison to the predicate device) | The fatigue strength of the DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is equivalent or better than that of the predicate device (DePuy Motech PEAK Anterior Compression Plate System). |
2. Sample size used for the test set and the data provenance
The document describes mechanical testing, not a test set for an AI or imaging device. Therefore, typical sample size and data provenance (country of origin, retrospective/prospective) for clinical data are not applicable here. The "sample size" would refer to the number of devices or constructs tested in the mechanical fatigue study. This specific number is not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes mechanical testing of a medical device, not a study requiring expert-established ground truth for a test set (e.g., for diagnostic accuracy).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the document describes mechanical testing. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not device mechanics.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, nor any AI component in this device. The device described is a physical anterior cervical plate system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the device is a physical implant, not an algorithm or software.
7. The type of ground truth used
For the mechanical testing, the "ground truth" would be the physical properties and performance of the predicate device under specific test conditions, as established through standard mechanical testing protocols.
8. The sample size for the training set
This section is not applicable as there is no AI or algorithm that would require a training set.
9. How the ground truth for the training set was established
This section is not applicable as there is no AI or algorithm that would require a training set.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.