The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.

The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.

The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.

Device Description

AI/ML Overview

The provided text describes a 510(k) summary for the PowerStar Bipolar Scissors, a medical device for cutting and coagulating soft tissue. However, it does not contain information about acceptance criteria, specific performance metrics, or a detailed study proving the device meets acceptance criteria as would be
expected for AI/ML-based medical devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and detailed study information based on the provided text.

Here's why and what information is available:

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

Information in text: The document states, "Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended."
Missing Information: No specific acceptance criteria (e.g., minimum cutting efficiency, maximum coagulation time, specific power delivery, etc.) are provided. No quantitative performance data against any such criteria is reported.

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

Information in text: The document mentions "preclinical laboratory and clinical evaluations" and "pre-clinical and clinical testing."
Missing Information: No details on sample sizes for any test sets, data provenance (country, retrospective/prospective), or the nature of these tests are supplied.

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):

Information in text: This concept is not applicable to the device described. The device is a surgical instrument, not an AI/ML diagnostic tool that relies on expert interpretation for ground truth.
Missing Information: Not relevant to this type of device.

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

Information in text: Not relevant to this type of device.
Missing Information: Not relevant to this type of device.

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:

Information in text: Not applicable. This is a surgical instrument, not an AI/ML diagnostic aid.
Missing Information: Not relevant to this type of device.

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

Information in text: Not applicable. This is a surgical instrument, not an AI/ML algorithm.
Missing Information: Not relevant to this type of device.

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

Information in text: Not applicable. The "ground truth" for a surgical instrument would be its functional performance (e.g., ability to cut tissue cleanly, achieve hemostasis) demonstrated through direct observation or measurable physical parameters in laboratory or clinical environments.
Missing Information: Not relevant in the context of typical AI/ML ground truth definition.

8. The sample size for the training set:

Information in text: No training set is mentioned as this is not an AI/ML device.
Missing Information: Not relevant to this type of device.

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

Information in text: No training set is mentioned as this is not an AI/ML device.
Missing Information: Not relevant to this type of device.

Summary from the provided text:

The document states that the PowerStar Bipolar Scissors are "substantially equivalent" to an existing legally marketed device. This determination is based on "preclinical laboratory and clinical evaluations" that "ensure that the device functions as intended" and provide "sufficient data...to assess that the device performs as clinically intended" and "assess the safety and effectiveness characteristics of the modified device."

Key Takeaway: The provided text is a 510(k) summary for a conventional surgical instrument, not an AI/ML-driven device. As such, it details the intended use, indications, and substantial equivalence claim, but it does not include the specific types of performance metrics, study designs (like MRMC), and ground truth methodologies that would be relevant for an AI/ML medical device.

Summary

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|C98136i/

SECTION 7

JUL 1 3 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act. respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

MODIFIED DEVICE PowerStar Bipolar Scissors NAME:

EXISTING (legally marketed) DEVICE NAME: PowerStar Bipolar Scissors

510(K) SUMMARY

Device Description

Intended Use

The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.

Continued on next page

PowerStar Bipolar Scissors ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Indications Statement

intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.

The PowerStar Bipolar Scissors are non-sterile, reusable devices

The modified device is technologically the same as the existing device.

Performance Data

Technological

Characteristics

Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended.

Sufficient data has been gathered from pre-clinical and clinical testing to assess the safety and effectiveness characteristics of the modified device.

Conclusions

Contact

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.

Gregory R. Jones Director Regulatory Affairs ETHICON, Inc. Rt. #22 West Somerville, NJ 08876-0151

. Date

PowerStar Bipolar Scissors ETHICON, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles a human figure or a bird in flight, composed of curved lines and shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jul 1 3 1998

Mr. Gregory R. Jones Director Regulatory Affairs Ethicon, Inc. A Johnson & Johnson Company P.O. Box 151 Somerville, New Jersey 08876

Re: K981361 Trade Name: PowerStar Bipolar Scissors Regulatory Class: II Product Code: GEI Dated: April 10, 1998 Received: April 14, 1998

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification

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Page 2 - Mr. Gregory R. Jones

submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981361

510(k) Number (if known):

Device Name:

Indications for Use:

INDICATION FOR USE

PowerStar Bipolar Scissors

"The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries".

Surgical procedures would include, among others, the following:

General Surgery Bowel Breast Biopsies Hernia Repair Lysis of Adhesions Upper GI GI (other) Cholecystectomy Thyroid Splenectomy

OB/GYN Surgery Hysterectomy

Myomectomy

Endometriosis

Salpingo-oophrectomy

Ovariohysterectomy

Oncological Surgery Mastectomy Axillary Node Dissection

Plastic Surgery Mammoplasty Blepharoplasty Rhytidectomy Panniculectomy Forearm Pedicle Flap Facial

Urological Surgery Nephrectomy Prostatectomy Cystotomy

Ear. Nose & Throat Surgery Neck Mass Mastoidectomy

Tympanoplasty Tonsillectomy

Cardiovascular/Thoracic_Surgery Femoral Popliteal Bypass Internal Mammary Artery (IMA) Harvesting Pericardial Window Biopsy of the Thymus

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)	X
OR	Over-The Counter Use _______ (Optional Format 1-2-9G)

PowerStar Bipolar Scissors
ETHICON, Inc.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

iii

And And Andrew States

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.