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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.

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.

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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 components are made of from medical grade titanium or titanium alloy.

The provided document is a 510(k) premarket notification for a medical device called the CENTERPIECE™ Plate Fixation System. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them. Specifically:

• No table of acceptance criteria and reported device performance: The document only describes the device, its intended use, and states that "Mechanical testing was performed on the CENTERPIECE™ Plate Fixation System and was included in this submission." It does not provide specific performance metrics or acceptance criteria for this testing.
• No sample size for the test set or data provenance: No clinical or test set data is provided.
• No number of experts or their qualifications: Not applicable as no ground truth or expert review process is described.
• No adjudication method: Not applicable.
• No multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• No standalone algorithm performance: The device is a physical implant, not an algorithm.
• No type of ground truth used: Not applicable.
• No sample size for the training set: Not applicable.
• No description of how ground truth for the training set was established: Not applicable.

The submission focuses on establishing substantial equivalence to a previously cleared device (Kirschner Orthopedic Wire, K850631) based on shared indications for use and general safety/functionality. It doesn't present a study designed to meet pre-defined performance acceptance criteria with a test set, ground truth, or expert review.

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