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K Number
K974170
Device Name
DUOSTAR
Manufacturer
MTI CORP./ ELECTROSTAR S.A.-HAITI
Date Cleared
1998-09-30

(329 days)

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

SALE AND USE FOR CAUTERIZING AND CUTTING FOR SURGICAL PROCEDURES.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) notification for the Duostar electrosurgical device does not contain the information requested for acceptance criteria and a study proving those criteria.

The 510(k) document primarily focuses on:

  • The device's trade name, regulatory class, and product code.
  • The finding of "substantial equivalence" to a predicate device.
  • General regulatory information, responsibilities of the manufacturer, and contact information for further guidance.
  • The indications for use for the device.

There is no mention of specific acceptance criteria (e.g., performance metrics, thresholds), details of a study that evaluated the device's performance against such criteria, sample sizes, expert qualifications, ground truth methods, or any information about AI or human-in-the-loop studies.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

§ 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.