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:

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.
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.
Number of experts used to establish the ground truth...: Not applicable as no ground truth establishment for a test set is described.
Adjudication method: Not applicable.
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.
Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable. This device is not an algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable as there is no mention of an algorithm or training set.
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.

Summary

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K061635

MSD BIPOLAR Forceps 510(k) Summary June 2006

Page 1 of 1

I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

SEP - 5 2006

Contact: Richard W. Treharne, PhD Vice President Regulatory Affairs

II. Proprietary Trade Name: MSD BIPOLAR Forceps

III. Classification Name: Electrosurgical Cutting and Coagulation and Accessories
IV. Regulation Number: 878.4400

Product Code: GEI Class: Class II

V. Product Description

VII Indications

VIII Substantial Equivalence

Documentation was provided which demonstrated the subject MSD BIPOLAR Forceps to be substantially equivalent to the CLARIS Non-Stick Bipolar Forceps previously cleared by the agency in K051429 (SE 07/29/05).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2006

Medtronic Sofamor Danek % Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pvramid Place Memphis, Tennessee 38132

Re: K061635

Trade/Device Name: MSD Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 11, 2006 Received: August 15, 2006

Dear Mr. Grant:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became as a get fie device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encrease of the enactment date of the Medical Device Amendments, or to conninered pror to rias 2017-11-11 in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval approval application (PMA). and Cosmetic rear (110.) that to hevice, subject to the general controls provisions of the Act. The r ou may, diererere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Lee Grant

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

661635

Device Name: MSD Bipolar Forceps

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, R. Boran. and Neurological Devices

510(k) Number K011636

000005

Regulation Number and Section

§ 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.