Bilayer Matrix Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, 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

Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semipermeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Bilayer Matrix Wound Dressing." It describes the device's intended use, description, and the results of certain tests. However, it does not include the detailed information required to answer your specific questions regarding acceptance criteria and the comprehensive study design you outlined.

Specifically, the document states:

Tests and Test Results: "Biocompatibility studies have demonstrated Bilayer Matrix Wound Dressing to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic and non-toxic."
Conclusion: "Valid scientific evidence through biocompatibility and physical property testing provide reasonable assurance that Bilayer Matrix Wound Dressing is safe and effective under the proposed conditions of use..."

This indicates that biocompatibility and physical property testing were performed, and the device met the criteria for those tests. However, the document does not elaborate on:

Specific Acceptance Criteria Values: It only states the device was "noncytotoxic," for example, but doesn't provide the quantitative metric or threshold used to define "noncytotoxic."
Detailed Study Design for each test: It doesn't describe the sample sizes, origin of data, "experts" involved, adjudication methods, or how ground truth was established for these biocompatibility and physical property tests.
Performance in Clinical Scenarios: The document does not describe a study involving clinical performance metrics like sensitivity, specificity, accuracy, or how human readers (if any) would perform with or without the device in a diagnostic context. This device is a wound dressing, not an AI diagnostic tool, so many of your questions related to AI performance, multi-reader studies, and ground truth based on pathology or outcomes data are not directly applicable or addressed in this type of submission.

Therefore, given the provided text, I cannot complete the table or answer most of your detailed questions about the study that "proves the device meets the acceptance criteria" in the way you've framed them for an AI/diagnostic device.

Here's what can be extracted based on the document:

Acceptance Criteria Category	Reported Device Performance	Study Type
Biocompatibility:
- Cytotoxicity	Noncytotoxic	In Vitro
- Pyrogenicity	Non-pyrogenic	In Vitro
- Irritation	Non-irritating	In Vitro
- Sensitization	Non-sensitizing	In Vitro
- Hemocompatibility	Non-hemolytic	In Vitro
- Toxicity	Non-toxic	In Vitro
Physical Properties:	(Not specified)	(Not specified, likely Lab Testing)

Regarding your specific questions, based only on the provided text:

A table of acceptance criteria and the reported device performance: See table above. Specific quantitative acceptance criteria are not detailed in the summary, only the qualitative outcome (e.g., "noncytotoxic").
Sample size used for the test set and the data provenance: Not mentioned for the biocompatibility or physical property tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned. Biocompatibility tests usually follow standardized protocols, not expert consensus for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or mentioned.
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 is a physical wound dressing, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, ground truth is typically established by the defined pass/fail criteria of the standardized test protocols (e.g., ISO standards for biocompatibility).
The sample size for the training set: Not applicable; this device does not use machine learning or AI models requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a wound dressing, focusing on its material properties and equivalence to predicate devices, rather than an AI or diagnostic device that would involve the extensive clinical validation and performance criteria you've outlined.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of three parts: a symbol resembling a caduceus on the left, the letters "FDA" in a square in the middle, and the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a staff with two snakes winding around it, enclosed in a circle.

November 18, 2019

Integra Lifesciences Corp. Diana Bordon Manager Of Special Projects 311 Enterprise Dr. Plainsboro, New Jersey 08536

Re: K021792

Trade/Device Name: Bilayer Matrix Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: May 30, 2002 Received: May 31, 2002

Dear Diana Bordon:

This letter corrects our substantially equivalent letter of August 14, 2002.

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kimberly Ferlin -S

Kimberly M. Ferlin, Ph.D. Assistant Director (acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Bilaver Matrix Wound Dressing 510(K) SUMMARY

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

AUG 1 4 2002

K021792

Contact person and telephone number:

Diana M. Bordon Manager, Regulatory Affairs, (609) 275-0500

Date: May 23, 2002

Name of the device:

Proprietary Name:	Bilayer Matrix Wound Dressing
Common Name:	Wound Dressing
Classification Name:	Dressing, Product Code 79FRO

Substantial Equivalence:

Bilayer Matrix Wound Dressing is substantially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): Oasis™ SIS Wound Dressing II (K993948), Fortaderm™ Wound Dressing (K014129), VitaChoice™ Wound Dressing (K896455) and Biobrane® II Temporary Wound Dressing (K896110).

Intended Use:

Device Description:

Tests and Test Results

Biocompatibility studies have demonstrated Bilayer Matrix Wound Dressing to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic and non-toxic.

Conclusion

Valid scientific evidence through biocompatibility and physical property testing provide reasonable assurance that Bilayer Matrix Wound Dressing is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

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Integra LifeSciences Corporation 510(k) Premarket Notification Bilayer Matrix Wound Dressing .

Confidential

INDICATIONS FOR USE

510(k) Number:

K02 1792

Page 1 of 1

Device Name: Bilayer Matrix Wound Dressing

Indications for Use:

Bilayer Matrix Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, sccond-degree burns, and draining wounds. The device is intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Usc
(Per 21 CFR 801.109)
Over-the-Counter Use
510(k) Number K071792 (Optional Format 1-2-96)

Regulation Number and Section

N/A