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The CarboClear® Hybrid 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 nonoperative treatment.

The CarboClear® Hybrid 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® Hybrid 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® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy set screw, and with CarboClear CFR-PEEK rods. The implants may include tantalum markers. CarboClear titanium alloy rod is also offered.

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

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

This document is a 510(k) premarket notification decision letter from the FDA regarding the CarboClear® Hybrid Pedicle Screw System. It declares the device substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. The document focuses on the mechanical and material properties of a surgical implant (pedicle screw system), not a software device or an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert information, adjudication, MRMC, standalone performance, ground truth, training set details) from this document as it pertains to a different type of medical device and regulatory review process.

The document covers:

• Device Name: CarboClear® Hybrid Pedicle Screw System
• Regulation Name: Thoracolumbosacral Pedicle Screw System (21 CFR 888.3070)
• Regulatory Class: Class II
• Purpose of Submission: Expansion of indications for use (specifically, longer rods).
• Performance Data Mentioned: Previously conducted static and dynamic tests according to ASTM F1717 and ASTM F1798, showing comparability to predicate devices.
• Conclusion: Substantial equivalence to predicate devices based on intended use, design, dimensions, materials, technological characteristics, principles of operation, and performance.

It explicitly states: "No new performance testing was necessary to support the current submission." This further confirms that no new clinical or AI/ML performance study was conducted for this specific submission.

To answer your request, you would need a document related to an AI/ML medical device submission, typically found in a "Clinical Performance" or "Software Validation" section of a 510(k) summary or a similar regulatory filing for AI/ML products.

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