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K Number
K994344
Device Name
NEUROTHERM RF CANNULA
Manufacturer
ROCKET MEDICAL PLC
Date Cleared
2000-03-21

(90 days)

Product Code
GXI
Regulation Number
882.4725
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Nourotherm Radiofrequency Lesion cannula is indicated for use in neurosurgical lesioning procedures. Examples of these procedures include, but are not limited to, lessioning of nerve fibers for the reatment of pain and lesioning of the brain, spinal cord as in thalamotomies, pallidotomies, cordotomics and hypophysectossiones.

Device Description

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and a study proving device performance. The document is a 510(k) submission summary for a "Neurotherm Radiofrequency Lesion Cannula" from Rocket Medical plc. The text focuses on:

  • Substantial Equivalence: It states that the device is substantially equivalent to existing devices and has been tested for safety and effectiveness for over 9 years without incident in the UK and other countries.
  • Regulatory Information: It includes the notification of intent to market, regulatory class, product code, and the FDA's response regarding the substantial equivalence determination.
  • Indications for Use: It specifies the neurosurgical lesioning procedures for which the cannula is intended.

The document does not contain:

  • Specific acceptance criteria (e.g., performance metrics, thresholds).
  • Details about a specific study designed to meet those acceptance criteria.
  • Information on sample sizes (test set, training set).
  • Data provenance, expert qualifications, or adjudication methods.
  • MRMC comparative effectiveness study results or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used or how it was established.

Therefore, I cannot populate the table or answer the specific questions based on the provided input. This document serves as a regulatory clearance notice, not a detailed technical study report.

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).