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K Number
K061635
Device Name
MSD BIPOLAR FORCEPS
Manufacturer
MEDTRONIC SOFAMOR DANEK
Date Cleared
2006-09-05

(85 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K051429
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Device Description

The MSD BIPOLAR Forceps are intended for use in general surgical procedures. The device is connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

AI/ML Overview

This document is a 510(k) summary for the MSD BIPOLAR Forceps, which is a submission to the FDA for medical device clearance. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical studies with predefined acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not typically found in a 510(k) summary of this nature.

Here's why and what can be inferred from the provided text:

  • Substantial Equivalence: The core of a 510(k) submission is to prove the new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use, and the same technological characteristics, or if technological characteristics differ, the differences do not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate.
  • Lack of Clinical Studies and Acceptance Criteria: For devices like bipolar forceps, substantial equivalence is often demonstrated through bench testing (e.g., electrical safety, mechanical strength), material compatibility testing, and performance testing against recognized standards. This typically does not involve large-scale human clinical trials with performance endpoints and acceptance criteria in the way you might see for a diagnostic AI device or a novel therapeutic.
  • No "Device Performance" Reported in Your Context: The document states the device's intended use and how it functions (grasp, manipulate, coagulate tissue with electrosurgical energy). It doesn't report performance metrics like sensitivity, specificity, accuracy, or reader agreement, because those are not relevant to demonstrating substantial equivalence for this type of electrosurgical accessory.

Based on the provided text, the answer to your request is:

There is no information in the provided 510(k) summary regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in the context you've outlined.

Here's a breakdown of why each point cannot be answered from the provided text:

  1. Table of acceptance criteria and reported device performance: This information is not present. The 510(k) focuses on a description of the device and its intended use, and then states its substantial equivalence to a predicate device.
  2. Sample size used for the test set and data provenance: No test set or clinical study data is mentioned from which to derive a sample size or data provenance.
  3. Number of experts used to establish the ground truth...: Not applicable as no ground truth establishment for a test set is described.
  4. Adjudication method: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is not conducted for 510(k) submissions of this nature. The document describes a device, not an AI algorithm assisting human readers.
  6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable. This device is not an algorithm.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable as there is no mention of an algorithm or training set.
  9. How the ground truth for the training set was established: Not applicable.

What is present in the document is the basis for clearance:

  • Substantial Equivalence: The MSD BIPOLAR Forceps are deemed substantially equivalent to the CLARIS Non-Stick Bipolar Forceps (cleared under K051429). This is the "study" that proves the device meets the regulatory requirements for market clearance under a 510(k) pathway. The "acceptance criteria" here are that the new device shares the same intended use and similar technological characteristics as the predicate, or that any differences do not raise new questions of safety or effectiveness.

§ 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.