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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 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 CarboClear implants include pedicle screws, rods and locking elements. 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.

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

I am sorry, but based on the provided document, I cannot extract the specific details about the acceptance criteria, the study that proves the device meets the acceptance criteria, or most of the other requested information (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, training set details).

This document is a 510(k) summary for a medical device (CarboClear® Pedicle Screw System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results in the format you've requested.

Here's what I can tell you from the document:

• Device: CarboClear® Pedicle Screw System
• Purpose: To restore the integrity of the spinal column in patients with advanced-stage tumors involving the thoracic and lumbar spine.
• Performance Data: "Performance characteristics included static and dynamic tests according to ASTM F 1717, and tests according to ASTM F 1798, ASTM F 2193, ASTM F 543; as well as fatigue lateral bending-axial rotation test and rod creep test. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device is safe and effective for its intended use."
• Clinical Data: "Clinical data for the CarboClear System was presented for the target population specified in the indications for use statement, and supports the safety and effectiveness of the device."

However, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm-only) performance (this is a hardware device, not an AI algorithm).
7. The type of ground truth used (beyond general "clinical data").
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This type of information would typically be found in a more detailed clinical study report, which is not part of this 510(k) summary.

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