The SS Matrix™ is intended for the management of wounds including: partial and fullthickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Device Description

The SS MatrixTM is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "SS Matrix™ Topical Wound Dressing." This submission is focused on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported performance metrics in the way a clinical trial for a novel device would.

Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this document, as a substantial equivalence filing does not typically include a detailed performance study with human readers, ground truth establishment, or specific statistical efficacy metrics.

However, I can extract information related to the tests and conclusions provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biocompatibility	Passed requirements of all tests	SS Matrix™ passed the requirements of all tests.

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

The document states, "The SS Matrix™ was subjected to a panel of tests to assess biocompatibility." It does not specify the sample size for these tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). This is typical for biocompatibility testing, which often involves in-vitro and in-vivo animal studies rather than human clinical trials.

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

Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on medical images) is not relevant for biocompatibility testing of a wound dressing.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting data, which is not described for the biocompatibility tests.

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

Not applicable. This device is a topical wound dressing, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant to this type of device.

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

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

For biocompatibility testing, the "ground truth" would be established by standardized laboratory assays and histological examinations, adhering to recognized safety standards (e.g., ISO 10993). The document doesn't detail these specifics but implies adherence by stating the device "passed the requirements of all tests."

8. The sample size for the training set

Not applicable. There is no AI component or training set involved for this device.

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

Not applicable. There is no AI component or training set involved for this device.

Summary

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K020732

9. 510(K) SUMMARY

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

February 26, 2002

Device:

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

SS MatrixTM Topical Wound Dressing Liquid bandage; 21 CFR 880.5090; Class I Product Code: 79KMF

Intended Use:

Predicate Devices:

The SS Matrix™ is similar to predicate collagen-based wound dressings that are currently marketed for the management of wounds including the SIS Wound Dressing II (D.C. #K993948) manufactured by Cook Biotech Incorporated, the FIBRACOL* Plus Collagen Wound Dressing (D.C. #K982597) manufactured by Johnson & Johnson Medical, and the EZ Derm™ Biosynthetic Wound Dressing (D.C. #K935189) manufactured by Brennen Medical Incorporated.

Device Description:

The SS MatrixTM is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.

Substantial Equivalence:

The SS Matrix™ is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalence.

Discussion of Tests and Test Results:

The SS Matrix™ was subjected to a panel of tests to assess biocompatibility. The SS Matrix™ passed the requirements of all tests.

Conclusions Drawn from Tests:

This device is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

MAY 3 0 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2002

Mr. Mark Bleyer President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, IN 47906

Re: K020732

Trade/Device Name: SS Matrix Regulatory Class: unclassified Product Code: KGN Dated: March 5, 2002 Received: March 6, 2002

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Muriam C. Provost

HUCelia 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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510(k) Number (if known): K02 0 7 3 2

Device Name: ____SS Matrix™

Indications For Use:

The SS Matrix is intended for the management of wounds including:

·Partial and full-thickness wounds
· Pressure ulcers
·Venous ulcers
·Diabetic ulcers
·Chronic vascular ulcers
· Tunneled/undermined wounds
· Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
· Draining wounds.

The 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)

Miriàm C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Regulation Number and Section

N/A