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K Number
K991399
Device Name
RADIONICS MICROELECTRODE KIT
Manufacturer
RADIONICS, INC.
Date Cleared
1999-09-21

(152 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

For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.

Device Description

The above device consists of a recording electrode, sheath, adaptor bushing, spacer and passing cannula. It is used with the Nueromap System, CRW Stereotaxtic frame and lesion generator to record signals in determining the placement of lesions.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. This 510(k) summary (K991399) primarily addresses the substantial equivalence of the Radionics Microelectrode Kit (MEK) to a predicate device based on its intended use and technological characteristics.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are mentioned.
  2. Sample size used for the test set and the data provenance: No test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
  4. Adjudication method: Not applicable as there is no described test set.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
  6. Standalone (algorithm only without human-in-the-loop performance) study: This device is a physical electrode kit, not an algorithm.
  7. The type of ground truth used: Not applicable as there is no described test set.
  8. The sample size for the training set: This device is a physical electrode kit, not a machine learning model.
  9. How the ground truth for the training set was established: Not applicable.

The submission focuses on basic device description, intended use, and comparison to a pre-amendments predicate device to demonstrate substantial equivalence, and not on performance studies with specific statistical endpoints or acceptance criteria.

§ 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).