The subject Sundt Slim-Line Aneurysm Clip Applier is a stainless steel reusable hand-held instrument that is available in two configurations a fixed tip applier and a hinged tip applier. All three appliers consist of a handle grip with serrations, a two-piece spring, a shaft, and a v-grooved shape tip for grasping the aneurysm clip. The fixed tip Sundt Slim-Line Aneurysm Clip Applier and the Sugita appliers are designed with shaft that angles down and a thin tip profile to provide the surgeon a greater field of view during clip placement.

AI/ML Overview

The provided document, a 510(k) summary for the Sundt Slim-Line Aneurysm Clip Applier, primarily focuses on demonstrating substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria for performance, a study proving those criteria were met, or any of the detailed aspects of a performance study (like sample sizes, ground truth establishment, or expert involvement) as typically required for AI/software-as-a-medical-device (SaMD) clearances today.

This submission is from 1998, a period predating widespread AI in medical devices and the current rigorous expectations for demonstrating AI/ML device performance. Devices like aneurysm clip appliers are mechanical instruments, and their clearance process historically relies on demonstrating substantial equivalence in design, materials, and intended use to predicate devices, rather than clinical performance metrics in the way AI algorithms are evaluated.

Therefore, most of the requested information cannot be extracted from this document. I will answer based on what is available in the document and state when information is not present.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified directly in the document. The core "acceptance criteria" for this 510(k) submission was demonstrating substantial equivalence to predicate devices (K791764A and K791978).	The device was found to be "substantially equivalent" to predicate devices based on a detailed device description, intended use, materials, design, sterilization, and packaging. The FDA reviewed the 510(k) notification and determined the device is substantially equivalent for the stated indications for use.

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

This information is not provided in the document. The clearance was based on substantial equivalence to predicate devices, not on a performance study with a test set.

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)

This information is not provided in the document. No "ground truth" was established in the context of a performance study for this device's clearance.

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

This information is not provided in the document. No test set or adjudication method was described as part of this 510(k) submission for the device itself.

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 information is not applicable and not provided in the document. The device is a mechanical surgical instrument (aneurysm clip applier), not an AI-based diagnostic or assistive tool that would involve human readers or AI assistance.

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

This information is not applicable and not provided in the document. The device is a mechanical surgical instrument, not an algorithm.

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

This information is not provided in the document. No "ground truth" as typically understood in performance studies was used for the clearance of this mechanical device.

8. The sample size for the training set

This information is not applicable and not provided in the document. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided in the document. This device is not an AI/ML algorithm.

Summary

{0}------------------------------------------------

K982379

DEC 18 1998

Exhibit I 510(k) Summary Sundt Slim-Line Aneurysm Clip Applier

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

1. Contact Person:

Janet G. Johnson Associate Regulatory Affairs Specialist (508) 828-3466

2. Device Information:

Proprietary Name: Common Name: Classification Name: Regulatory Class: Product Code:

Sundt Slim-Line Aneurysm Clip Applier Aneurysm Clip Applier Aneurysm Clip Applier Class II, per 21 §CFR 882.4175 84 HCl

3. Indications for Use:

The Sundt Slim-Line Aneurysm Clip Applier is designed for use only with Sundt Slim-Line Aneurysm Clips.

4. Device Description:

5. Substantial Equivalence:

The determination of substantial equivalence for the Sundt Slim-Line Aneurysm Clip Applier was based on a detailed device description, intended use, materials, design, sterilization, and packaging to the Aneurysm Clip Applier (K791764A) and the Sugita Aneurysm Clip Applier (K791978).

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1998

Ms. Janet G. Johnson, RAC Associate Regulatory Affairs Specialist Johnson and Johnson Professional, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K982379 Trade Name: Sundt Slim-Line Aneurysm Clip Applier Regulatory Class: II Product Code: HCI Dated: October 29, 1998 Received: October 30, 1998

Dear Ms. Johnson:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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. Failure to comply with the GMP regulation 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 Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

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 labeling 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 vours.

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

{3}------------------------------------------------

K982379

510(k) Number (if known) Device Name

Sundt Slim-Line Aneurysm Clip Applier

Indications For Use

The Sundt Slim-Line Aneurysm Clip Applier is designed for use only with Sundt Slim-Line Aneurysm Clips.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

bcoole

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

Prescription Use X
(Per 21 CFR §801.109)

Over-the-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.4175 Aneurysm clip applier.

(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).