The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing. coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures. Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

Device Description

ISOCOOL Bipolar Forceps consist of an insulated, reusable handle in irrigating and non-irrigating styles and sterile, disposable tips.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria or a detailed study proving that the "CODMAN ISOCOOL Bipolar Forceps" meets such criteria. Instead, it describes a 510(k) premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices.

The document focuses on the regulatory process for device clearance, stating that "Substantial equivalence for this device was based upon comparison to predicate device characteristics and performance testing. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use." However, it does not provide the specifics of these "performance testing" results beyond this general statement.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that performance testing was conducted to demonstrate substantial equivalence, but it does not detail specific acceptance criteria (e.g., specific thresholds for coagulation efficiency, temperature profiles, or mechanical strength) or report quantitative performance data for the device against such criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not mention the sample size of any test sets used or the provenance of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Cannot be provided. This type of information is typically related to diagnostic or image-based devices where expert interpretation establishes a "ground truth." For a surgical instrument like bipolar forceps, the "ground truth" would likely be operational performance metrics and safety, which are generally evaluated through engineering tests, benchtop studies, and potentially animal or cadaver studies, rather than expert-established diagnostic ground truth. There is no mention of experts establishing a ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Cannot be provided. Adjudication methods are usually relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies need to be resolved. This is not applicable to the type of device and testing implied here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This type of study (MRMC, AI assistance) is for diagnostic devices or AI-driven systems, not for a standalone surgical instrument like bipolar forceps.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This refers to AI algorithms. The device is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be provided definitively. As mentioned in point 3, the concept of "ground truth" in the diagnostic sense is not explicitly applicable here. For a surgical instrument, "ground truth" would likely be defined by successful functional performance (e.g., effective coagulation, mechanical integrity, safety) as measured by engineering specifications and relevant test standards. The document only states "performance testing" was done without specifying the nature of that testing or how success was defined.

8. The sample size for the training set

Not applicable. There is no indication of a "training set" as this device is not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. As above, no training set is mentioned or implied.

In summary, the provided document is a 510(k) summary for regulatory clearance, not a detailed technical report of device performance testing. It asserts that performance testing was done to demonstrate substantial equivalence, but it does not disclose the specifics of that testing.

Summary

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EXHIBIT A

K023566

510(k) Summary CODMAN ISOCOOL Bipolar Forceps

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person

Elizabeth Dolan Regulatory Affairs Specialist Telephone Number: (508) 828-3262 Fax Number: (508) 828-3212

Name of Device

Proprietary Name:	CODMAN ISOCOOL Bipolar Forceps
Common Name:	Bipolar Forceps
Classification Name:	Electrosurgical Cutting and Coagulation Device

Device Classification

Electrosurgical Cutting and Coagulation Device and Accessories are Class II devices per 21 CFR § 878.4400 (79 GEI).

Statement of Substantial Equivalence

CODMAN ISOCOOL Bipolar Forceps are substantially equivalent to Codman Mirror Finish Bipolar Forceps, Seedling Enterprises, LLC, Cool-Tec Reusable Bipolar Electrodes and Cool-Tec Bipolar Electrodes, and Link Technology Non-Stick Bipolar Forceps based on the subject device's similarity to the predicate devices in intended use, materials, design, and principles of operation.

Indications for Use

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Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

Physical Description

ISOCOOL Bipolar Forceps consist of an insulated, reusable handle in irrigating and non-irrigating styles and sterile, disposable tips.

Device Testing________________________________________________________________________________________________________________________________________________________________

Substantial equivalence for this device was based upon comparison to predicate device characteristics and performance testing. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

MAY 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Dolan Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K023566

Trade/Device Name: Codman IsoCool Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 1, 2003 Received: May 2, 2003

Dear Ms. Dolan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 - Ms. Elizabeth Dolan

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark N. Millman

Celia M. Witten, Ph.D., M.D. 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):

K023566

Device Name:

CODMAN ISOCOOL Bipolar Forceps

. . . . . .

Indications For Use:

The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing, coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures.

Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

leo Charles N. Mellem

(Division Sign-Off) Dision of General, Restorative and Neurological Devices

510(k) Number K023566

Prescription Use
(Per 21 CFR §801.109)

Over-the-Counter Use

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.