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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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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.

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, locking components (a set screw and a nut) and transverse connectors. 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, and includes a small tantalum marker.

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

This document is a 510(k) summary for the CarboClear® X Pedicle Screw System, a medical device. It does not present acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria.

Instead, it provides:

• Device Name: CarboClear® X Pedicle Screw System
• Intended Use/Indications for Use: To restore the integrity of the spinal column (even in the absence of fusion for a limited time) in patients with advanced stage thoracic and lumbar spine tumors who have insufficient life expectancy to permit fusion.
• Regulation Number and Device Class: 21 CFR §888.3070; Class II
• Product Code: NKB
• Predicate Devices: CarboClear® Pedicle Screw System (K173487, K182377, K201926) as the primary predicate, and several additional predicate devices from other manufacturers.
• Performance Data: Static and dynamic tests were performed according to ASTM F1717 and ASTM F1798.
• Conclusion: The device is substantially equivalent to its predicate devices based on intended use, design, material, dimensions, technological characteristics, and principles of operation, and its performance test results are comparable.

Therefore, since the provided text relates to a traditional medical device (pedicle screw system) and not an AI/ML powered device, I cannot extract the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.

Ask a specific question about this device