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The CarboClear® X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.

The CarboClear® X Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The CarboClear® X Pedicle Screw System is 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, and a locking element (set screw). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants may include tantalum markers. Titanium alloy rod is also available.

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

The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

The provided text describes the 510(k) premarket notification for the CarboClear® X Pedicle Screw System. This document is a regulatory submission for a medical device, specifically spinal implants. It focuses on demonstrating that the new device is substantially equivalent to existing predicate devices already on the market.

Crucially, this document does not describe studies proving device meets acceptance criteria related to AI/software performance or diagnostic accuracy. It primarily discusses the mechanical performance and material equivalence of a physical implant system (pedicle screws) to predicate devices, and an expansion of its indications for use.

Therefore, many of the requested items related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained within this regulatory submission.

However, I can extract information relevant to the device's performance as understood in the context of this specific regulatory submission for a physical medical device:

Acceptance Criteria and Device Performance (Mechanical/Physical)

For this type of medical device (pedicle screws), "acceptance criteria" and "performance" relate to mechanical and material characteristics rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document mentions "Performance Data" from mechanical tests (ASTM F1717, ASTM F1798). It does not specify the sample size for these tests (e.g., number of constructs tested, number of screws).
• The data provenance is not explicitly stated beyond being part of this 510(k) submission by CarboFix Orthopedics Ltd. (Israel-based company). It's scientific laboratory data gathered for regulatory purposes, typically conducted in a controlled lab environment. It is prospective testing for the submission, not retrospective data.

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

• This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM standards) and the physical measurements obtained from those tests, not by expert human interpretation.

4. Adjudication method for the test set:

• Not applicable for mechanical testing.

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 as this is not an AI/software device.

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

• Not applicable as this is not an AI/software device.

7. The type of ground truth used:

• The "ground truth" for this device's performance relies on objective physical measurements derived from standardized mechanical testing (e.g., load-displacement curves, fatigue life) compared against established performance benchmarks within the specific ASTM standards for spinal implants and demonstrating comparability to predicate devices.

8. The sample size for the training set:

• Not applicable as this is not an AI/software device.

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

• Not applicable as this is not an AI/software device.

Summary regarding the provided document:

The provided document (a 510(k) clearance letter and summary) is for a physical medical device (pedicle screw system), not an AI/software device. As such, the "acceptance criteria" and "performance studies" described are entirely focused on the mechanical and material properties of the implant, demonstrating its substantial equivalence to already cleared devices. The detailed questions about AI, ground truth, experts, and MRMC studies are not relevant to the content of this specific regulatory submission.

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