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K Number
K013668
Device Name
BERCHTOLD ELEKTROTOM 106 HITT
Manufacturer
BERCHTOLD CORP.
Date Cleared
2002-02-04

(90 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

This device is intended for the coagulation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Device Description

The BERCHTOLD ELEKTROTOM® 106 HiTT® is an electrosurgical system consisting of a high frequency energy generator, syringe pump, needle applicators and accessories.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the studies conducted to prove the BERCHTOLD ELEKTROTOM® 106 HiTT® device meets them. The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies against acceptance criteria.

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number and 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.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document states that "The minor differences between the BERCHTOLD ELEKTROTOM® 106 HiTT and the predicate device raises no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This indicates that the device was cleared based on its similarity to an already legally marketed device, and not necessarily on extensive new performance studies against predefined acceptance criteria for the new device itself.

§ 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.