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The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The PEEK CAS is a curved implant constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LT1) as described by ASTM F-2026. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for additional bone growth through the device. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

This 510(k) submission (K050861) for the PEEK CAS device does not include a study describing acceptance criteria, device performance, or ground truth establishment based on clinical data or expert evaluations.

Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices (Interpore Cross Expandable PEEK VBR (K040928) and Interpore Cross NEXUS (K040168)) through:

• Same indications for use: The device targets the same clinical conditions and anatomical region as the predicates.
• Intended use: The purpose of the device (partial vertebral body replacement) aligns with the predicates.
• Similarity in materials of construction: It uses PEEK OPTIMA™ LT1, a medical-grade material, also used in similar devices.
• Equivalent biomechanical performance: This typically implies that the device has undergone non-clinical (e.g., in-vitro mechanical) testing to demonstrate its structural integrity and mechanical properties are comparable to the predicate devices and suitable for its intended use. However, the specific details or results of such tests (acceptance criteria, performance data) are not provided in this summary.

Therefore, I cannot populate the table or answer most of your specific questions as the provided text does not contain that information.

Here's what can be inferred or explicitly stated from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not applicable / Not provided: The document describes a substantial equivalence submission based on device characteristics and intended use, not a clinical study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided: No clinical ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable / Not provided: No clinical test set or adjudication process is described.

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

• No: This is a medical device for vertebral body replacement, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with human readers and AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No: This is a physical implant, not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not provided in the context of clinical performance evaluation: The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior approval and marketing. The PEEK CAS aims to meet this "ground truth" through equivalence in design, materials, and biomechanical performance.

8. The sample size for the training set

• Not applicable / Not provided: No computational model or AI training is described.

9. How the ground truth for the training set was established

• Not applicable / Not provided: No computational model or AI training is described.

Summary of Device and Submission Type:

This 510(k) submission for the PEEK CAS is for a physical implantable medical device used for vertebral body replacement. The primary method for gaining market clearance is by demonstrating substantial equivalence to already approved predicate devices, rather than conducting new clinical trials that would involve the kind of performance data, acceptance criteria, and ground truth establishment you are asking about. The "study" mentioned would primarily consist of engineering and materials testing to show equivalent biomechanical performance.

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