N-TERFACE Interpositional Surfacing Material is indicated for use as a wound contact layer for partial thickness burns and and confection worselves of laser skin resurfacing. indicated for use as a wound concace in ......................................................................................................................................

Device Description

N-TERFACE® Interpositional Surfacing Material is an extruded, non-woven, high density polyethylene sheeting material with the following physical properties: Weight, oz/yd2: 0.36 to 0.8, Thickness, Mils: 4.0 to 5.0, Tensile, Ibs/in .: roll direction 14 to 77, cross direction 1.5 to 4.5, Air Permeability ft3/min/ft2: 545 to 1144.

AI/ML Overview

The provided text is a 510(k) Summary for the N-TERFACE® Interpositional Surfacing Material, which is a medical device. This document is a regulatory submission to the FDA for market clearance, not a study report detailing clinical acceptance criteria and performance data in the way requested by the prompt.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics of a device-proving study cannot be found or inferred from this document.

The document primarily focuses on establishing "substantial equivalence" to a predicate device for regulatory approval.

Here's a breakdown of what can be extracted and why other parts cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not present acceptance criteria for performance in a clinical study format, nor does it report specific device performance metrics against such criteria. The "performance" described is limited to physical properties of the material (weight, thickness, tensile strength, air permeability) for which acceptance criteria are not explicitly stated. The core "performance" for regulatory purposes is its substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or clinical study data is presented in this 510(k) summary. The submission relies on the device being "physically identical" to a previously cleared device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No test set or ground truth establishment process for a performance study is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is described as there is no test set or clinical outcome data presented.

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

Cannot be provided. This device is an interventional material, not an AI diagnostic tool. No MRMC study or AI-related information is present.

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

Cannot be provided. This device is an interventional material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. The document does not describe the use of ground truth for a performance study. Its "ground truth" for regulatory equivalence is the functional properties and intended use of the predicate device.

8. The sample size for the training set

Cannot be provided. This device is a physical material, not an AI algorithm. There is no concept of a "training set" in this context.

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

Cannot be provided. As above, no training set or ground truth for it exists in this context.

Summary of available information related to "acceptance" (regulatory, not clinical performance):

The "acceptance criteria" in this context are interpreted as the requirements for Substantial Equivalence for FDA 510(k) clearance.

Predicate Device: N-TERFACE® Interpositional Surfacing Material (K820198) manufactured by Winfield Laboratories, Inc.
Basis for Equivalence: The new device (for laser skin resurfacing) is "physically identical" to the predicate device (for partial thickness burns). The argument is that wounds from laser skin resurfacing are partial thickness burns, making the new indication a subset of the previously cleared use.

No clinical study data is presented to "prove" the device meets acceptance criteria in the traditional sense of a performance study with outcome measures. Regulatory acceptance is based on demonstrating equivalence to a device already on the market without a new safety or effectiveness question.

Summary

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473538

DEC 1997

510 (k) Summary as required by 807.92(c) for N-TERFACE® Interpositional Surfacing Material Prepared July 10, 1997

Submitted by:	Winfield Laboratories, Inc.10488 Brockwood RoadDallas, Texas 75238214/553-8072
Contact Person:	Gary W. CummingsExecutive Vice President

Device Trade Name: N-TERFACE® Interpositional Surfacing Material.

Wound contact layers have not been classified. Classification:

N-TERFACE® Interpositional Surfacing Material Predicate Device: manufactured by Winfield Laboratories, Inc., 10488 Brockwood Road, Dallas, TX 75238. (K820198).
Description of Device:

Intended Use of Device:

N-TERFACE® Interpositional Surfacing Material is intended for use as the primary wound contact layer after laser skin resurfacing.

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K473338

Substantial Equivalence to Predicate Device:

N-TERFACE Interpositional Surfacing Material indicated for use in laser skin resurfacing is physically identical to N-TERFACE® Interpositional Surfacing Material (K820198) indicated for use in the treatment of partial thickness burns. The wounds created in laser skin resurfacing are partial thickness burns. The material with this new explicit indication for a subset of the previously cleared use is therefore substantially equivalent to the device described in K820198.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1997

Mr. Gary W. Cummings Executive Vice President Winfield Laboratories, Inc. 10488 Brockwood Road Dallas, Texas 75238

Re: K973538

N-TERFACE™ Interpositional Surfacing Material Regulatory Class: Unclassified Product Code: MGP Dated: September 18, 1997 Received: September 18, 1997

Dear Mr. Cummings:

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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:

1. This device may not be labeled for use on third degree burns.
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual

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Page 2 - Mr. Gary W. Cummings

registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.

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,

a 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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SIAK) Number (if known):	K973538
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N-TERFACE Interpositional Surfacing MaterialDevice Name:

Indications For Usc:

· ·· . . ・・・・・

N-TERFACH interpositional Surfacing Matcrial is indicated for use as a wound contact layer for partial thickness burns
and and confection worselves of laser skin resurfacing. indicated for use as a wound concace in ......................................................................................................................................

(I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IT NEEDED)

Coucurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices 12973534 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Formal 1-2-96)

Regulation Number and Section

N/A