Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.

Device Description

Porcine Dermal Xenograft is an acellular, sterile, porcine dermal xenograft for use in treatment of topical wounds. The product is available in several sizes.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically addressing the acceptance criteria and study proving device performance, although it's crucial to note that this document describes a medical device (a xenograft) and NOT an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies (like sample size for training, expert ground truth, MRMC studies, etc.) are not applicable to this submission.

The provided document, K113866, is a 510(k) summary for a Porcine Dermal Xenograft. This is a traditional medical device (a biological product derived from animal tissue for wound care), not an AI/ML powered device. As such, the "acceptance criteria" and "study" described are focused on bench testing and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than performance metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML.

Let's address the points as best as possible given the nature of the device:

Acceptance Criteria and Device Performance (for a Porcine Dermal Xenograft)

Given that this is a Porcine Dermal Xenograft and not an AI/ML-powered device, the concept of "acceptance criteria" is tied to its material properties, biocompatibility, and functionality for wound management, as demonstrated through bench testing and comparison to predicate devices. There are no performance metrics like sensitivity, specificity, or AUC as would be seen for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test/Biocompatibility)	Reported Device Performance
Technological Characteristics:	Identical to predicate devices (Porcine Surgical Mesh, PriMatrix, and LTM Wound Dressing).
Biocompatibility (ISO 10993-1):	"The product met all of the stated requirements of each test." This implies successful completion of tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, etc., as per ISO 10993-1 standards for medical devices. Specific numerical results are not provided in this summary.
Safety and Effectiveness for Intended Use:	"Bench testing has demonstrated that the device is safe and effective for its intended use..."
Substantial Equivalence:	"...and that its performance is substantially equivalent to the predicate devices."

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

Sample Size: Not explicitly stated in terms of a "test set" for performance metrics typical of AI models. The "sample" would refer to the number of xenograft units used for bench testing (e.g., tensile strength, hydration properties, porosity) and biocompatibility testing. This kind of detail is usually found in the full 510(k) submission, not the summary.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here comes from laboratory bench tests and in vitro or in vivo biocompatibility studies conducted by or for Brennen Medical. The country of origin for such data would typically be the location of the testing laboratories. The study is not retrospective or prospective in the sense of a clinical trial used for AI/ML validation; it refers to device specific analytical and biocompatibility testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is not an AI/ML device where expert consensus is used to label medical images or clinical outcomes. Ground truth for a xenograft involves laboratory standards (e.g., specified ranges for material properties, pass/fail for biocompatibility tests). The "experts" would be the scientists and engineers conducting the tests and interpreting the results against established standards.

4. Adjudication Method for the Test Set

Not Applicable. There is no "adjudication" of expert opinions as would be needed for an AI/ML test set. The results of the bench tests and biocompatibility tests are empirical measurements and observations against pre-defined acceptance criteria for those tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. This device is a physical wound dressing and does not involve human "readers" or image interpretation. Its "effectiveness" is demonstrated through its physical and biological properties for wound management, and comparison to predicate devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is not an algorithm. The device "performance" is its intrinsic physical and biological characteristics.

7. The Type of Ground Truth Used

Engineering and Biological Standards / Predicate Device Equivalence. The "ground truth" for this device's performance is established by:
- Validated laboratory test methods: Meeting predefined specifications for physical properties (e.g., strength, porosity, sterility) through bench testing.
- ISO 10993-1 Biocompatibility Standards: Pass/fail criteria for biological safety tests.
- Comparison to predicate devices: Demonstration that the new device's characteristics and performance are "identical" or "substantially equivalent" to legally marketed predicate devices, which have already demonstrated safety and effectiveness for similar intended uses.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device and therefore does not have a "training set."

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

Not Applicable. As there is no training set for this type of device, no ground truth needs to be established for it.

In summary, the provided document is a 510(k) summary for a traditional medical device (a xenograft). The "acceptance criteria" and "study" proving its performance are based on bench testing, biocompatibility testing against international standards (ISO 10993-1), and demonstrating substantial equivalence to already cleared predicate devices, rather than the AI/ML-specific performance metrics and study designs (like MRMC, training/test sets, expert ground truth) that your questions imply.

Summary

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K113866 page 1/2

MAR 2 3 2012

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

16.1 SUBMITTER INFORMATION

Brennen Medical, LLC

Original Pre-market 510(k) Notification

a. Company Name:	Brennen Medical, LLC
b. Company Address:	1290 Hammond RoadSt. Paul, MN 55110
c. Company Phone:Company Facsimile:	(651) 429-7413(651) 429-8020
d. Contact Person:	Kenneth B. HerlandV.P. Regulatory Affairs/QA
e. Date Summary Prepared:	December 28, 2011

DEVICE IDENTIFICATION 16.2.

a. Trade/Proprietary Name:
b. Regulation Number :
C. Regulation Name :
ದೆ. Device Class :
Product Code : e.

Porcine Dermal Xenograft (TBD) N/A Porcine Dermal Xenograft Unclassified KGN

16.3 IDENTIFICATION OF PREDICATE DEVICES

Company	Device	510(k) No.	Date Cleared
Brennen Medical	Porcine Surgical Mesh	K111436	10/12/2011
Lifecell's	LTM Wound Dressing	K082103	10/08/2008
TEI Biosciences	PriMatrix	K083440	12/12/2008

16.4 DEVICE DESCRIPTION

Porcine Dermal Xenograft is an acellular, sterile, porcine dermal xenograft for use in treatment of topical wounds. The product is available in several sizes.

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K113866 page 2/2

Brennen Medical, LLC Original Pre-market 510(k) Notification

SUBSTANTIAL EQUIVALENCE 16.5

Porcine Dermal Xenograft is substantially equivalent to TEI's PriMatrix and Lifecells ATM Wound Dressing along with Brennen's Porcine Surgical Mesh. Porcine Dermal Xenograft is equivalent in intended use, mode of action, and design to the predicate devices. The introduction of this product does not raise any new issues of safety or effectiveness.

16.6 INTENDED USE

16.7 TECHNOLOGICAL CHARACTERISTICS

The technological characteristics are identical to the predicate devices (Porcine Surgical Mesh, PriMatrix and LTM Wound Dressing). The ISO 10993-1 required Biocompatibility testing was conducted on the product. The product met all of the stated requirements of each test.

Bench testing has demonstrated that the device is safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices.

CONCLUSIONS 16.8

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. Test evaluations of Porcine Dermal Xenograft IS that the device performs as intended and substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Brennen Medical, LLC % Mr. Kenneth Herland VP Regulatory Affairs/QA 1290 Hammond Road Saint Paul, Minnesota 55110

Re: K113866

Trade/Device Name: Porcine Dermal Xenograft Regulatory Class: Unclassified Product Code: KGN Dated: February 13, 2012 Received: February 14, 2012

Dear Mr. Herland:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

MAR 2 3 2012

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Page 2 - Mr. Kenneth Herland

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHVCDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

For Dpt
Mark N. Melkerson/DSO (110)

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Brennen Medical, LLC Original Pre-market 510(k) Notification

INDICATION FOR USE

510(k) Number:

Device Name: Porcine Dermal Xenograft

Indications for Use: Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use
(Division Sign-Off)	Daniel Rone for Mxy
Division of Surgical, Orthopedic, and Restorative Devices

CONFIDENTIAL
Page 23 of 156

§10(k) Number	K113866
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Regulation Number and Section

N/A