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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 deqenerative disc disease (DDD) at one level 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 an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

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-PEEEK). 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 CarboClear® X Navigated Instruments are manually operated instruments, intended to be used with Medtronic's StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X pedicle screws during spinal surgery.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of AI/ML or medical imaging performance. The document is an FDA 510(k) clearance letter for the CarboClear® X Pedicle Screw System and CarboClear® X Navigated Instruments, which are physical medical devices (implants and surgical instruments) for spinal surgery.

The performance data mentioned relates to mechanical testing of the pedicle screw system (e.g., static and dynamic bending, torsion) according to ASTM standards, not to the performance of an AI algorithm or a diagnostic imaging system. Therefore, I cannot extract the information required to populate the requested table and answer the questions about AI/ML model performance, ground truth, expert consensus, or MRMC studies.

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