(131 days)
The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
The CENTERPIECE™ Plate Fixation System consists of a variety of sizes of plates and screws. The CENTERPIECE™ Plate Fixation System screws are made of from medical grade titanium or titanium alloy. Screws will be provided sterile and non-sterile and are reusable.
This FDA 510(k) K212428 submission is for a medical device, the CENTERPIECE™ Plate Fixation System, and not a software or AI/ML device. Therefore, the questions regarding acceptance criteria, study details, and ground truth establishment for AI/ML performance are not applicable in this context.
The document describes the device, its intended use, and its substantial equivalence to a predicate device based on performance testing of its mechanical properties and MRI safety, not on AI/ML diagnostic or predictive performance.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of numerical acceptance criteria for each test and reported performance values. Instead, it summarizes the types of performance testing conducted to demonstrate functionality and compatibility, and ultimately, substantial equivalence to the predicate device. The conclusion states that the implants "have shown through comparison and testing to be substantially equivalent to the identified predicate devices." This implies that the performance met the unstated acceptance criteria for demonstrating equivalence.
| Test | Description | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Static Compression | Compare the static compression properties of the CENTERPIECE™ subject and predicate screw-plate constructs. Compressive load applied in the posterior to anterior direction to simulate in vivo loading conditions. | Performance comparable to the predicate device. | Achieved comparable static compression performance to the predicate device. |
| MRI Safety Evaluation | Evaluate the MRI safety of the CENTERPIECE™ Plate Fixation System. | Demonstrates acceptable MRI safety for clinical use. | Demonstrated acceptable MRI safety. |
| Pull Out Strength Evaluation | Engineering rationale to address pullout strength testing of the CENTERPIECE™ Plate Fixation System. | Achieves adequate pullout strength for its intended application. | Achieved adequate pullout strength. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test dataset of images or other clinical data. The "test set" refers to physical samples of the device undergoing mechanical and safety testing. The specific number of devices tested is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of device performance, would be established by engineering standards, material properties, and regulatory requirements, not by expert consensus on clinical data.
4. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data, which is not relevant here.
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: Not applicable. This device is not an AI/ML product.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This device is not an AI/ML algorithm.
7. The type of ground truth used: For mechanical tests (Static Compression, Pull Out Strength), the "ground truth" would be established by engineering specifications, material science principles, and relevant ISO/ASTM standards for spinal fixation devices. For MRI Safety, the ground truth is based on established guidelines and testing protocols for medical device compatibility within MRI environments.
8. The sample size for the training set: Not applicable. This is not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML product.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.