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The CarboClear® Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear® II Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear® and CarboClear® II Pedicle Screw Systems are composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.

The implants include pedicle screws, rods, locking elements and transverse connectors. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell, and includes a small tantalum marker.

The implants are supplied sterile, and are intended for single use.

This document is a 510(k) Premarket Notification and does not describe acceptance criteria for a device's performance based on clinical study data, nor does it detail a study proving such performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing rather than clinical outcomes or diagnostic accuracy.

Therefore, many of the requested elements (e.g., sample size for test sets, expert adjudication, MRMC studies, ground truth for training/test sets) are not applicable or findable within this document, as they relate to clinical or AI/diagnostic performance studies, which were not the basis for this specific device clearance.

The "device" in this context is a CarboClear® Pedicle Screw System and CarboClear® II Pedicle Screw System, which are medical implants. The "performance" being evaluated here is primarily mechanical performance, not diagnostic accuracy or human-in-the-loop improvement for complex medical tasks often associated with AI/diagnostic devices.

Here's an attempt to answer the questions based on the provided document, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in the way one might for a diagnostic device (e.g., minimum sensitivity/specificity). Instead, it states that the performance characteristics (mechanical) were evaluated against standards, and the results were comparable to predicate devices. This implies the acceptance criterion was "comparable mechanical performance" as demonstrated by meeting specified ASTM standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify mechanical test sample sizes. Mechanical testing typically involves a set number of samples per test condition (e.g., n=6 for fatigue testing). These are in vitro tests, not patient data.
• Data Provenance: Not applicable for a mechanical performance study. The tests were performed in vitro to ASTM standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth and expert review are relevant for diagnostic or AI performance studies involving interpretation of medical data. This document describes mechanical testing of an orthopedic implant.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies. This is a mechanical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No. An MRMC study is relevant for diagnostic performance, evaluating how human readers perform with or without AI assistance on medical cases. This document covers mechanical testing of a pedicle screw system.

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

Not applicable. This is not an AI/algorithm-based diagnostic device. The performance refers to the physical mechanical properties of the implant itself.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic "ground truth." For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM F1717, F1798, F2193, F543) and demonstrable equivalence to predicate devices under these test conditions.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of why requested information is largely absent:

The provided text is a 510(k) summary for a pedicle screw system, which is an implantable medical device. The clearance is based on substantial equivalence to existing predicate devices, primarily demonstrated through mechanical performance testing (in vitro engineering tests) rather than clinical studies or diagnostic accuracy evaluations. Many of the questions posed directly relate to the methodology of AI/diagnostic device studies (e.g., human reader performance, training/test sets, expert ground truth, MRMC studies), which are not performed for this type of device clearance.

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