LogoFDA 510(k) Search
K Number
K971143
Device Name
NEURO PULSE II,III
Manufacturer
AARON MEDICAL INDUSTRIES
Date Cleared
1997-06-06

(70 days)

Product Code
ETN
Regulation Number
874.1820
Type
Traditional
Panel
Ear Nose & Throat
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The subject device of this premarket notification submission (K-971143) is indicated for use as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document snippets, I cannot extract the specific details about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the Neuro Pulse II and Neuro Pulse III devices, indicating that they are substantially equivalent to pre-amendments devices.

The information provided outlines:

  • The FDA's decision regarding K971143 (Neuro Pulse II and Neuro Pulse III).
  • The regulatory class and procode.
  • The general controls provisions of the Act.
  • The indication for use: "as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery."

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Information about MRMC comparative effectiveness studies or effect sizes.
  6. Information about standalone algorithm performance studies.
  7. Type of ground truth used in such studies.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This type of information would typically be found in the actual 510(k) submission document itself, or a summary of it, not in the FDA's clearance letter.

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.