The UltraCision Harmonic Scalpel is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, gynecological ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures and oropharyngeal airway, and thoracic surgery including mobilization of the Internal Mammary Artery (IMA).

Device Description

The UltraCision Harmonic Scalpel is an ultrasonically activated surgical blade with a protective sleeve. These instruments are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.

AI/ML Overview

The provided document is a 510(k) summary for the Ethicon Endo-Surgery UltraCision® Harmonic Scalpel® Blades with Protective Sleeve. This document describes a medical device, and the information requested pertains to the evaluation of AI/ML-based medical devices. Therefore, much of the requested information regarding AI-specific criteria (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, I can extract the information related to the device's performance evaluation as described within the context of a traditional medical device submission.

Here's a breakdown of the available information:

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

Acceptance Criteria (Implied)	Reported Device Performance
Satisfactory cutting	Demonstrated satisfactory performance in cutting.
Satisfactory coagulation	Demonstrated satisfactory performance in coagulation.
Satisfactory performance for expanded indication	The clinical information demonstrated satisfactory performance for the expanded indication.

Explanation: The document does not explicitly state numerical acceptance criteria. Instead, it uses qualitative terms like "satisfactory performance." The device is deemed to have met these criteria as it received substantial equivalence.

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

Sample Size for Test Set: Not specified. The document refers to "bench testing and animal studies" and "clinical information," but no sample sizes for these studies are provided.
Data Provenance: Not specified. The studies are generalized as "bench testing and animal studies" and "clinical information." It's common for such studies to be conducted internally or by contract research organizations, but specific details like country of origin or whether they were retrospective/prospective are not given.

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/not specified. For this type of traditional medical device (surgical scalpel), "ground truth" as it relates to expert review of output like images or diagnoses is not relevant. The performance is assessed through direct observation, measurement, and clinical outcomes during the studies.

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

Not applicable/not specified. Adjudication methods are typically relevant for studies where subjective interpretation or classification of data (like medical images) is involved.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a physical surgical device, not an AI/ML-based diagnostic or assistive software.

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

Not applicable. This device is a surgical instrument that requires direct human operation. It is not an algorithm.

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

The implicit "ground truth" for this device would be established through direct observation of cutting and coagulation efficacy and safety endpoints in bench testing, animal studies, and clinical observations/outcomes during the use of the device. This is more akin to direct performance measurement rather than establishing a "ground truth" for classification or diagnosis.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Ethicon Endo-Surgery, Inc. The logo consists of a circular graphic on the left, followed by the company name in a simple, sans-serif font. Below the company name, it says "a Johnson & Johnson company" in a cursive font.

K 012176

4545 CREEK ROAD
CINCINNATI, OH 45242-2839

OCT - 1 2001

SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY: Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242

CONTACT: Ruth Ann Wood Senior Regulatory Affairs Associate Telephone: 513/337-3468 FAX: 513/337-1444

DATE PREPARED: July 11, 2001

NAME OF THE DEVICE: UltraCision® Harmonic Scalpel® Blades with Protective Sleeve Classification LFL

PREDICATE DEVICE: UltraCision® Harmonic Scalpel® Blades with Protective Sleeve

DEVICE DESCRIPTION:

INTENDED USE/INDICATION FOR USE:

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TECHNOLOGICAL CHARACTERIZATION:

The UltraCision Harmonic Scalpel is a medical device that uses ultrasonic energy to cause mechanical vibrations to cut and coagulate soft tissues.

PERFORMANCE DATA:

All previously submitted bench testing and animal studies demonstrated satisfactory performance in cutting and coagulation. The clinical information demonstrated satisfactory performance for the expanded indication.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2001

Ms. Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K012176

Trade/Device Name: UltraCision®Harmonic Scalpel® Blades with Protective Sleeve Regulation Number: 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: LFL Dated: July 11, 2001 Received: July 12, 2001

Dear Ms. Wood:

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. Ruth Ann Wood

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.

Mark N. Millerson

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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Page _ of _

510(k) NUMBER (IF KNOWN): K012176

DEVICE NAME: Ultra Cision Harmonic Scalpel Blades with Protective Sleeve

INDICATIONS FOR USE:

The Harmonic Scalpel is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpel in general, gynecologic, ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of Internal Mammary Artery (IMA).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter-Use (Optional Format)

for Mark N Melberson

al, Restorative

510(k) Number K012176

Regulation Number and Section

N/A