The provided text is a 510(k) Premarket Notification for the SurgiSIS™ Surgical Mesh. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of AI, expert evaluations, and sample sizes for training/test sets.

The document focuses on demonstrating substantial equivalence to predicate devices through similar intended use and technological characteristics, and by passing a panel of tests for biocompatibility, integrity, and performance. It does not describe explicit numerical acceptance criteria, nor does it detail a study using AI or involving human readers as would typically be found in more modern submissions for AI/ML-driven medical devices.

Based on the provided text, here’s an attempt to answer the questions, highlighting where information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Not Explicitly Stated for this 510(k))	Reported Device Performance	Comments
Biocompatibility	(Likely adherence to ISO 10993 standards)	"SurgiS/S™ passed the requirements of all tests."	The document indicates successful completion of biocompatibility tests.
Integrity	(Likely related to mechanical strength, durability)	"SurgiS/S™ passed the requirements of all tests."	The document indicates successful completion of integrity tests.
Performance	(Likely related to its function in reinforcing soft tissue)	"SurgiS/S™ passed the requirements of all tests."	The document indicates successful completion of performance tests.
Substantial Equivalence	Demonstrated similarity in intended use and technological characteristics to predicate devices.	Stated to be "substantially equivalent" to predicate devices.	The primary mechanism for clearance in this 510(k).

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

Sample Size for Test Set: Not specified. The document globally states "a panel of tests" of "SurgiS/S™ material," but no specific sample sizes for these tests are provided.
Data Provenance: Not specified. This would typically be from laboratory testing on the device material itself.

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

Number of Experts: Not applicable. The "ground truth" for a material device like SurgiSIS™ during its 1998 submission would be based on validated laboratory testing methods, not expert consensus on image interpretation or diagnosis.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Clinical adjudication is not relevant for the type of material testing described. Laboratory tests have pre-defined pass/fail criteria.

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

MRMC Study: No. This is a 1998 510(k) for a surgical mesh material. AI assistance, human reader studies, and MRMC designs are not relevant to this type of device and were not part of the regulatory pathway for such products at that time.

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

Standalone Study: No. As mentioned, this device is a surgical mesh material, not an algorithm or AI product.

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

Type of Ground Truth: For the material tests (biocompatibility, integrity, performance), the "ground truth" would be established through scientific testing methodologies and established standards (e.g., ISO standards for biocompatibility, mechanical test standards for integrity) with clear pass/fail criteria.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI/ML product developed using training sets.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria:

The document briefly states: "The SurgiS/S™ material was subjected to a panel of tests to assess biocompatibility, integrity, and performance. SurgiS/S™ passed the requirements of all tests."

This indicates that a series of in vitro and potentially in vivo tests (for biocompatibility) were conducted. However, the 510(k) summary does not provide details about these specific tests, their methodologies, the exact acceptance criteria employed, or the specific results. The clearance was based on the applicant's assertion that it passed these tests and demonstrated substantial equivalence to predicate devices, which had already established safety and effectiveness.

In summary, the provided document is a regulatory submission for a traditional medical device (surgical mesh) from 1998. It does not contain information related to AI/ML device testing, which typically involves the detailed performance metrics, expert evaluations, and dataset specifics you've asked for.

Summary

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K980431

510(k) Premarket Notification: SurgiS/STM 1

MAY 2 8 1998

I. 510(K) SUMMARY

Submitted By:

Neal E. Fearnot. Ph.D. President Cook Biotech, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (765) 497-3355 February 2, 1998

Names of Device:

Trade Name: Common/Usual Name: Proposed Classification Name:

SurgiSIS™ Surgical Mesh, Soft Tissue Patch Surgical Mesh (21 CFR §878.3300)

Predicate Devices:

Supple Peri-Guard® Pericardium (K961810) manufactured by Bio-Vascular, Inc. GraftPatch® Soft Tissue Surgical Patch (K970561) manufactured by Organogenesis, Inc. DEXON Polyglycolic Acid Mesh (K830889) manufactured by Davis & Geck, Inc.

Device Description:

SurgiS/S™ is supplied in sheet form in sizes ranging from 16 cm² to 360 cm². The device is packaged in sterile sealed pouches.

Intended Use:

SurgiS/S™ is intended to be used for implantation to reinforce soft tissue. It is intended for one-time use.

Substantial Equivalence:

SurgiSIS™ is substantially equivalent to the predicate devices, having similar intended use and technological characteristics.

Discussion of Tests and Test Results:

The SurgiS/S™ material was subjected to a panel of tests to assess biocompatibility, integrity, and performance. SurgiS/S™ passed the requirements of all tests.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 1998

Neal E. Fearnot, Ph.D. ·President Cook Biotech Incorporated P.O. Box 2603 3055 Kent Avenue West Lafayette, Indiana 47906

K980431 Re: SurgiSIS™ Surgical Mesh Trade Name: Regulatory Class: II Product Code: FTM Dated: April 30, 1998 Received: May 5, 1998

Dear Dr. Fearnot:

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. ಗಿ 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 In addition, FDA may publish further announcements action. 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.

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Page 2 - Dr. Fearnot

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 yours,

Celia M. Witten, Ph.D.,

Ph.D., M.D. a M. Director 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):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

SurgiS/S™ is intended for implantation to reinforce soft tissue. This device is intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of General Restorative Devices
510(k) Number K980431

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_ (Optional Format 1-2-96)

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.