The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.

Device Description

The SIS Hernia Repair Device is intended to be used for reconstructing and supporting soft tissues such as fo the repair of a hernia or body wall defect. The device is supplied sterile and is intended for one-time use. The material comprising the device has undergone appropriate biocompatibility and performance testing that provides reasonable assurance of safety and efficacy for its intended use.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested parameters such as sample sizes, expert qualifications, or ground truth methods.

This document is a 510(k) summary for the SIS Hernia Repair Device. It primarily focuses on demonstrating "substantial equivalence" to predicate devices, rather than detailing a specific clinical performance study with acceptance criteria.

Here's what can be extracted from the text, along with what is explicitly not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	"The material comprising the device has undergone appropriate biocompatibility and performance testing that provides reasonable assurance of safety and efficacy for its intended use." (General statement, no specific metrics or targets reported)

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document refers generally to "biocompatibility and performance testing" but provides no details on the nature or results of these tests.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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 device is a physical hernia repair device, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI would not be applicable, and no such study is mentioned.

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

This question is not applicable as the device is a physical medical implant, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not specified. The document broadly states "biocompatibility and performance testing," but the specific methods or underlying "ground truth" used for these tests are not detailed. For a physical device, this might refer to histological analysis, mechanical strength tests, or animal model outcomes, but none are elaborated upon.

8. The sample size for the training set

Sample Size (Training Set): Not specified. The concept of a "training set" in the context of device performance data, as understood for AI/machine learning, is not applicable or discussed for this physical device.

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

Ground Truth Establishment (Training Set): Not applicable, as there is no mention of a training set for an algorithm.

Summary of Information Provided:

The document is a regulatory submission focused on substantial equivalence. It confirms:

The device is a SIS Hernia Repair Device (surgical mesh).
It's intended for reconstructing and supporting soft tissues (hernia or body wall defect repair).
It's supplied sterile and for single-use.
It has undergone "appropriate biocompatibility and performance testing" to assure safety and efficacy.
It is considered substantially equivalent to predicate surgical meshes in terms of indications for use and technological characteristics.

The 510(k) process, particularly in 1998, often relied on demonstrating equivalence to already cleared devices rather than requiring highly detailed de novo clinical performance studies with specific statistical endpoints and ground truth mechanisms as would be expected for a novel diagnostic algorithm today.

Summary

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510(k) Premarket Notification SIS Hernia Repair Device MAY 20 1998

K974540

510(K) SUMMARY I.

Submitted By:

Robert J. Morff, Ph.D., P.E. Associate Director, Medical Technology Sentron Medical, Incorporated 4445 Lake Forest Drive, Suite 600 Cincinnati, Ohio 45242 (513) 563-3254 November 26, 1997

Device:

Trade Name Common/Usual Name: Proposed Classification:

SIS Hernia Repair Device Hernia Patch, Tissue Patch, Surgical Mesh Surgical Mesh 21 CFR Part 878.3300 (uoFTL) Class II

Predicate Devices:

The SIS Hernia Repair Device is similar to predicate surgical meshes in terms of indications for use, and technological characteristics.

Device Description:

Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will be packaged and sterilized using validated sterilization procedures. This device is similar with respect to indications for use and technology to predicate devices in terms of section 510(k) substantial equivalency.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Robert J. Morff, Ph.D., P.E. ·Associate Director, Medical Technology Senmed Medical Ventures Sentron Medical, Incorporated 4445 Lake Forest Drive, Suite 600 Cincinnati, Ohio 45242

K974540 Re : SIS Hernia Repair Device Trade Name: Regulatory Class: II Product Code: FTL Dated: April 2, 1998 Received: April 3, 1998

Dear Dr. Morff:

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 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.

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Page 2 - Dr. Morff

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., M.D.

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: SIS Hernia Repair Device

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Resionative Devices 510(k) Number

Image /page/3/Picture/8 description: The image shows the words "Prescription Use" with a check mark next to it. Below that, it says "(Per 21 CFR 801.109)". The text is in black and white.

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.