The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Description

TissueLink Bipolar Floating Ball device

AI/ML Overview

This document is a 510(k) summary for the TissueLink Bipolar Floating Ball device. It primarily focuses on demonstrating substantial equivalence to a predicate device for an expanded indication of an already cleared device, rather than proving performance against specific acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This is not a study focused on a diagnosis or prediction, but rather on the safety and efficacy of a medical device (an electrosurgical instrument).

Here's an attempt to address the points based on the provided document, noting where the information is not available or not applicable:

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

This document does not contain a table of acceptance criteria or reported device performance in the way one would for a diagnostic or prognostic device. The submission is for expanded indications for an electrosurgical device. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating substantial equivalence in terms of safety and effectiveness to a legally marketed predicate device for the stated indications.

The key "performance" demonstrated here is the intended use and mechanism of action being substantially equivalent to the predicate device, but for a broader range of surgical applications.

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

Not applicable. This is a 510(k) submission demonstrating substantial equivalence for an electrosurgical device, not a study evaluating an AI algorithm's performance on a test set. There is no "test set" in the context of diagnostic accuracy from patient 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. There is no ground truth established by experts for a test set in this type of submission.

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

Not applicable. No test set for diagnostic accuracy.

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 is not an AI-assisted diagnostic or imaging device.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The "ground truth" for a 510(k) supporting expanded indications is typically based on design specifications, material compatibility, functional testing, and potentially clinical literature or prior device history relative to the predicate device, demonstrating that the device continues to meet its functional and safety requirements across the expanded set of indications.

8. The sample size for the training set

Not applicable. There is no training set for an AI algorithm in this context.

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

Not applicable. No training set.

Summary based on the document:

The provided document is a 510(k) summary for the TissueLink Bipolar Floating Ball device seeking clearance for expanded indications. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (the identical device, TissueLink Bipolar Floating Ball, K#020574).

Acceptance Criteria (Implicit for a 510(k) for Expanded Indications): The device must continue to be as safe and effective as the predicate device when used for the expanded indications. This is assessed through demonstrating that the device's technological characteristics, principles of operation, and performance fall within the scope of the predicate device's cleared uses, or that any differences do not raise new questions of safety or effectiveness.
Study Proving Acceptance Criteria: The document itself is the "study" (regulatory submission) that argues the device meets these implicit criteria. It states: "Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball device is made to: Identical device, TissueLink Bipolar Floating Ball, K#020574." The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The expanded indications are: "The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery." Earlier clearance (K#020574) likely covered a narrower set of these applications.

Summary

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510(k) Premarket Submission – TissueLink Medical, Inc. –

Expanded indications Bipolar Floating Ball device

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510(k) Summary of Safety and Effectiveness

FEB 1 2 2003

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Application Information:

Date Prepared:	July 31, 2002
Submitter:	TissueLink Medical Inc.
Address:	One Washington Center Suite 400Dover, NH 03820
Contacts:	Vicki S. AnastasiDirectory Regulatory Affairs
Telephone Number:	(508) 922-1622
FAX Number:	(508) 497-9925
	Roberta L. ThompsonVice President, Clinical, Regulatory and Quality
Telephone Number:	(603) 742-1515 ext. 106
Fax Number:	(603) 742-1488
Device Information:
Trade Name:	TissueLink Bipolar Floating Ball device
Common Name:	Electrosurgery Cauterizing Pen
Classification Name:	Electrosurgical cutting and coagulation device and accessories. 21CFR.

Predicate Devices:

Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball device is made to:

Identical device, TissueLink Bipolar Floating Ball, K#020574

878.4400

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2003

Ms. Vicki S. Anastasi Director, Regulatory Affairs TissueLink Medical, Inc. One Washington Center, Suite 400 Dover, New Hampshire 03820

Re: K022532

Trade/Device Name: TissueLink Bipolar Floating Ball Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 13, 2002 Received: November 14, 2002

Dear Ms. Anastasi:

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 mav 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. Vicki S. Anastasi

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 yours,

Miriam C. Provost

for 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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Expanded indications Bipolar Floating Ball device

Indications for use Statement

Page _____ of ________________________________________________________________________________________________________________________________________________________________

K022532 510(k) Number (if known):

Device Name:

TissueLink Bipolar Floating Ball device

Indications for Use:

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use
(Per 21 CFR 801.109)

	OR	Over-The-Counter Use
--	----	----------------------

	Optional Format 1 -
--	---------------------

	Miriam C. Provost(Division Sign-Off)Division of General, Restorativeand Neurological Devices
--	----------------------------------------------------------------------------------------------------------

TissueLink Medical, Inc.	510(k) Number	KO22532
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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.