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The CAPRI Corpectomy Cage Systems is a vertebral body replacement device intended for use in the thoracolumbar spine (T) to L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The CAPRI Corpectomy Cage Systems is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.

For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium) and adjustable (titanium and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

This document describes the CAPRI Corpectomy Cage System, a vertebral body replacement device. This summary focuses on its regulatory clearance and mechanical testing, not a study involving AI or human readers for diagnostic accuracy. Therefore, many of the requested categories (like sample size for test sets, expert qualifications, HRMC studies, etc.) are not applicable to the information provided.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "performed equally to or better than these systems" (referring to predicate devices) in the mechanical tests. This implies that the predicate devices' performance served as the acceptance criteria benchmark. The specific quantitative acceptance values are not provided in this summary.

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

• Sample Size for Test Set: Not applicable in the context of a "test set" for an AI or diagnostic device. For the mechanical and biocompatibility testing, the sample size would refer to the number of physical devices or components tested. This detail is not provided in the summary.
• Data Provenance: Not applicable for the type of testing described (mechanical and biocompatibility testing of a physical device). The tests were conducted in a laboratory setting. There is no mention of patient data, clinical studies, or country of origin for such data.

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

• Not applicable. This document describes mechanical and biocompatibility testing of a physical medical device, not a diagnostic device requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This document describes mechanical and biocompatibility testing of a physical medical device.

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 not a study of AI or a diagnostic device, so an MRMC comparative effectiveness study was not performed.

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

• Not applicable. This document describes a physical medical device (corpectomy cage), not a software algorithm.

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

• For mechanical testing, the "ground truth" or reference standard would be the established performance characteristics and safety profiles of the predicate devices, along with the requirements of the ASTM standards (F2077, F2267). The device's performance was compared directly to these benchmarks.
• For biocompatibility testing (BET/LAL), the "ground truth" is compliance with the specified standard (ANSI/AAMI/ST72:2011), which sets limits for endotoxin levels to ensure safety.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model.

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

• Not applicable. No training set for an AI model is involved.

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