Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.

Device Description

The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (ACCUSHEAR Laparoscopic Surgical Instruments), not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it applies to AI/ML performance metrics and studies is not directly applicable in the same way.

However, based on the provided text, I can infer the "acceptance criteria" for this device from the perspective of substantial equivalence to a predicate device, and the "study" is the information provided in the 510(k) submission itself that demonstrates this equivalence.

Here's how I can interpret and answer your request in the context of this specific regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device 510(k), the "acceptance criteria" is typically demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is that the new device performs as safely and effectively as the predicate, with no new questions of safety or effectiveness.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance
Similar Intended Use: Perform the same clinical function.	"Intended to delivery energy from an independent monopolar electrosurgical generator to cut and dissect various abdominal tissue for use during laparoscopic, inclusive of endoscopic surgical procedures where instruments are introduced into the body through a cannula." (Matches predicate's likely use).
Similar Technological Characteristics: Similar design, materials, and operational principles.	"A modified version of the predicate Microline 'Re-New' (K962119)" with a "minor device modification related to the shaft and handpiece connection."
No New Questions of Safety or Effectiveness: The modifications do not introduce new risks or reduce effectiveness.	The modification "does not affect the relative safety or effectiveness of the Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments relative to their predicate."

2. Sample size used for the test set and the data provenance

This is not applicable for this type of device and submission. There is no "test set" in the context of an AI/ML device relying on data. The submission relies on a comparison of the device's design and intended use to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. There is no ground truth, test set, or expert review in this sense for a traditional surgical instrument 510(k). The "ground truth" is established by the existing regulatory clearance and safe market history of the predicate devices.

4. Adjudication method for the test set

This is not applicable. There is no test set or adjudication method for this type of submission.

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

This is not applicable. This is not an AI/ML device, and no MRMC study would be performed.

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

This is not applicable. This is not an AI/ML device.

7. The type of ground truth used

For a traditional 510(k) like this, the "ground truth" (if you can call it that) is the demonstration of substantial equivalence to a legally marketed device that has already established its safety and effectiveness. This is based on:

Predicate Device History: The predicate devices ("Re-New" K962119 and "Selec-Tip" K980758) have already been cleared by the FDA, implying their safety and effectiveness have been appropriately assessed.
Design Rationale: The manufacturer's rationale that the minor modification to the shaft and handpiece connection does not affect safety or effectiveness.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, and there is no training set.

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

This is not applicable. There is no training set for this type of device.

In Summary for this Specific Device:

The "study" proving the device meets "acceptance criteria" for a 510(k) is the submission itself, which articulates:

The device's description and intended use.
The identification of predicate devices with established safety and effectiveness.
A detailed comparison demonstrating that the new device is substantially equivalent to the predicate, particularly highlighting that any modifications are minor and do not introduce new safety or effectiveness concerns.

The FDA's review of this submission and subsequent clearance (K982984) serves as the "proof" that the device meets the regulatory acceptance criteria for market entry via the 510(k) pathway.

Summary

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OCT 21 1998

10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"

A. Submittor Information
Microline, Inc. 100 Cummings Center Suite 350-G Beverly, MA 01915

Telephone:	(978) 922-9810
Contact Person:	Mr. Huges de LaforcePresident

Date Prepared: August 24, 1998

B. Device Identification

Common/Usual Name:	Manual Detachable Surgical Instruments
Proprietary Name:	ACCUSHEAR Laparoscopic Surgical Instrument

C. Identification of Predicate Device(s)

The Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments are substantially equivalent to their predicates offered by Microline Inc. "Re-New" (K962119) and "Selec-Tip" (K980758) previously cleared and currently marketed.

D. Device Description

E. Substantial Equivalence

The Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments are a modified version of the predicate Microline "Re-New" (K962119) with a minor device modification related to the shaft and handpiece connection and does not affect the relative safety or effectiveness of the Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments relative to their predicate.

The Microline ACCUSHEAR Laparoscopic Surgical Instruments are intended to delivery energy from an independent monopolar electrosurgical generator to cut and dissect various abdominal tissue for use during laparoscopic, inclusive of endoscopic surgical procedures where instruments are introduced into the body through a cannula.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Microline, Inc. Ms. Jacqueline E. Masse Senior Consultant c/o Interactive Consulting, Inc. 70 Walnut Street Wellesley, Massachusetts 02481

K982984 Re: Trade Name: ACCUSHEAR Laparoscopic Surgical Instruments Requlatory Class: II Product Code: GEI Dated: Auqust 24, 1998 Received: August 26, 1998

Dear Ms. Masse:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. प्र substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

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Page 2 - Ms. Jacqueline E. Masse

Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (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,

CeNia M. Witten, Ph.D., M.D.
Director
Division of General and

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ___ K982984

Device Name: ACCUSHEAR Laparoscopic Surgical Scissors Instruments

Indications For Use:

Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801 109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. L982904

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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.