LogoFDA 510(k) Search
K Number
K974735
Device Name
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE
Manufacturer
AARON MEDICAL INDUSTRIES
Date Cleared
1998-06-24

(188 days)

Product Code
JOS,GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Device is used for cutting and/or coagulation during open surgical procedures.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for an electrosurgical device. It primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device.

The document does not contain information about:

  • Acceptance criteria for a study.
  • Detailed study design or methodology.
  • Device performance metrics from a study.
  • Sample sizes for test or training sets.
  • Ground truth establishment methods.
  • Information on expert qualifications or adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval, not a scientific study report.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.