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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 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, a set screw and transverse connectors. They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell, and includes a small tantalum marker. The implants are supplied sterile, and are intended for single use.

CarboClear® X Navigated Instruments are reusable, manually operated, instruments, including probes, bone taps and a screwdriver. These instruments are 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 provided document is a 510(k) premarket notification summary for the CarboClear® X Pedicle Screw System and CarboClear® X Navigated Instruments. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a clinical study.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way requested by the prompt for a typical AI/medical device performance evaluation.

The "Performance Data and Substantial Equivalence" section describes the types of tests conducted:

• For CarboClear® X Pedicle Screw System: Tests according to ASTM F1717 and ASTM F1798. These are standards for mechanical testing of spinal implants and pedicle screw systems, respectively.
• For CarboClear® X Navigated Instruments: Engineering analysis - comparative dimensional measurements.

These tests are designed to show that the new device performs similarly to previously cleared predicate devices, not to set and individually meet new "acceptance criteria" for a novel device performance claim.

Therefore, I cannot populate the requested table and sections as the information is not present in the provided text. The document describes a substantial equivalence pathway, where the performance is compared to predicates rather than against newly established acceptance criteria based on clinical outcomes or specific performance metrics.

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