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The CarboClear® X 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.

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 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.

When used in conjunction with High V+ ® Bone Cement, the CarboClear® X Fenestrated 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® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement 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. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

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 for minimally invasive surgical procedures include pedicle screws, rods, and a set screw (locking element). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. Implants may include tantalum markers. The implants are supplied sterile, and are intended for single use.

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

The CarboClear® X Fenestrated Pedicle Screw System consists of cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near the screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body. The Screws are implanted with the components of the CarboClear® X Pedicle Screw System. The CarboClear® X Fenestrated Screw System is made of carbon fiberreinforced polyetheretherketone (CFR-PEEK). The threaded portion of the screws is encased within a thin titanium shell, and includes a small tantalum marker. The CarboClear® X Fenestrated Screw System is supplied sterile, and is intended for single use.

High V+® Bone Cement is self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzovl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.N-dimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.

The provided document is a 510(k) summary for the CarboClear® X Pedicle Screw System and related components. It does not contain any information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through design validation, including engineering analyses and testing. The purpose of this submission is to add a minimally invasive surgery approach option to previously cleared devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This document doesn't provide performance metrics against specific acceptance thresholds for an AI/algorithm.
• Sample size and data provenance for a test set: Not applicable, as there's no mention of an algorithm test set.
• Number of experts and their qualifications for ground truth: Not applicable.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic device.
• Standalone algorithm performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document describes a typical 510(k) submission for a physical medical device (pedicle screw system), where substantial equivalence is demonstrated through material properties, design specifications, and mechanical testing, rather than clinical performance of an AI algorithm.

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