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K Number
K992186
Device Name
QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
Manufacturer
CONMED CORP.
Date Cleared
1999-07-30

(31 days)

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

For use in laparoscopic and open surgical procedures to provide r of ass iral cutting and electrosurgical hemostasis of tissue as well as grasping and manipulation of the tissue.

Device Description

ConMED QUAD™ Bipolar Laparoscopic Coagulating and Cutting Instrument

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ConMed QUAD Bipolar Laparoscopic Coagulating And Cutting Instrument). This document primarily focuses on regulatory approval and does not contain the detailed technical or clinical study information required to answer your specific questions about acceptance criteria, device performance, study design, or ground truth establishment.

Specifically, the document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Information on sample sizes, data provenance, number of experts for ground truth, adjudication methods, or ground truth types for a test set.
  3. Details about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
  4. Information about standalone algorithm performance.
  5. Details on training set size or how ground truth for the training set was established.

This document confirms substantial equivalence to a predicate device based on the indications for use, but it does not provide the technical studies or clinical trial results that would typically contain the information you are requesting.

§ 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.