The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Device Description

The SIS Plastic Surgery Matrix is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "SIS Plastic Surgery Matrix." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct effectiveness through clinical trials with defined acceptance criteria for device performance as would be typical for a novel and complex AI/software device.

Therefore, many of the requested categories related to acceptance criteria and ground truth for a software study do not directly apply to this particular document. The "study" here refers to demonstrating substantial equivalence through in vitro and biocompatibility testing, not a clinical efficacy study with human readers or AI algorithms.

Here's an analysis based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Device must be biocompatible. (Implicit: No adverse biological reactions)	Outcomes show the device to be biocompatible.
Viral Inactivation: Manufacturing processes must adequately disinfect the material.	Manufacturing processes adequately disinfect the material.
Tensile Strength: Sufficient tensile strength for soft tissue reinforcement. (Specific quantitative criteria are not provided in this summary.)	Tensile strength... to be sufficient.
Suture Retention Strength: Sufficient suture retention strength for soft tissue reinforcement. (Specific quantitative criteria are not provided in this summary.)	Suture retention strength to be sufficient.
Substantial Equivalence: Similar intended use, materials, and technological characteristics to predicate devices.	Evidence of suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics as shown through in vitro and biocompatibility testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of a "test set" for an AI/software device. The testing described (biocompatibility, viral inactivation, mechanical testing) applies to the material of the device rather than a clinical dataset. No specific number of samples for these tests is mentioned.
Data Provenance: Not applicable in the context of clinical data provenance. The "data" comes from in vitro and biocompatibility testing of the porcine small intestinal submucosa material itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There is no concept of "ground truth" established by experts for a test set in this 510(k) summary. The evaluation focuses on material properties and manufacturing processes.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this summary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study type is relevant for AI-assisted image interpretation or diagnostic tools, which this device is not.

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

Not applicable. This is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/software sense. The "ground truth" for this device's evaluation is derived from standard scientific and engineering methodologies for material testing (e.g., laboratory measurements for tensile strength, viral assays for inactivation, histological analysis for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary

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9. 510(K) SUMMARY

Mark Bleyer, President Submitted By: Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 (765) 497-3355 February 04, 2004

Names of Device:

SIS Plastic Surgery Matrix Trade Name: Surgical Mesh Common/Usual Name: Proposed classification name: Surgical Mesh 21 CFR 878.3300 (FTM) Class II

Intended Use:

Predicate Devices:

The SIS Plastic Surgery Matrix is similar to predicate devices, including the SURGISIS® Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated, Permacol (K013625) manufactured by Tissue Science Laboratories, PLC, and Advanta PTFE Facial Implant (K992991) manufactured by Atrium Medical Corporation.

Device Description:

Substantial Equivalence:

The SIS Plastic Surgery Matrix is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through in vitro and biocompatibility testing.

Discussion of Tests and Test Results:

The material comprising the SIS Plastic Surgery Matrix was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and tensile strength and suture retention strength to be sufficient.

Conclusions Drawn from the Tests:

Outcomes from the evaluation of the SIS Plastic Surgery Matrix provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics.

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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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

Mr. Mark Bleyer President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, Indiana 47906

Re: K034039

Trade/Device Name: SIS Plastic Surgery Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: December 24, 2003 Received: December 29, 2003

Dear Mr. Blever:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mark Bleyer

This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

iriam C. Provost

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

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The SIS Plastic Surgery Matrix is for implantation to relnforce soft THS CO T laste Cargory mists in patients requiring soft tissue repair or relnforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K034039

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.