The Advanced Medical Solutions Silicone Scar Management Sheet intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Advanced Modical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of: Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Device Description

Advanced Medical Solutions Silicone Scar Management Gel sheet is a soft, self-adhesive, semi-occlusive sheet made from medical grade silicone with a polyurethane film backing paper and a non siliconised polyester release paper.

The primary function of the dressing is to aid in the management of both existing and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

The Advanced Medical Solutions Silicone Scar Management Sheet comes in two sizes 3in. x 4in. and 1in. x 4in. the sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar, also two or more sheets may be placed together to cover a scar area that is greater than the area of a single sheet.

The Advanced Medical Solutions Silicone Scar Management Sheet is self adhesive but can also be secured by a lightly conforming bandage or tape if so desired.

The gel sheets are supplied either sterile or non-sterile in foil laminated sterilizable pouches.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device: "Advanced Medical Solutions Silicone Scar Management Sheet." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study with specific acceptance criteria and performance metrics for the novel device itself.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document as such information is typically part of a clinical trial or performance study report, which is not included here.

However, I can extract information related to the device's intended use and the predicate device used for comparison, which indirectly touches upon performance similarities.

Here's a breakdown of what can be inferred or explicitly stated from the document:

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

This document does not provide a table of acceptance criteria and reported device performance in the way a clinical study report would. The core of this 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. The "acceptance criterion" for a 510(k) is essentially that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness.

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

This document does not describe a test set or clinical study with a specified sample size. The substantial equivalence argument relies on comparing the device's characteristics (materials, design, intended use, operating principles) to a predicate device, rather than new clinical data from a test set.

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)

Not applicable, as no test set or clinical study to establish ground truth is described.

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

Not applicable, as no test set or clinical study is described.

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 silicone gel sheet for scar management, not an AI-assisted diagnostic tool.

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

Not applicable, as this is not an AI algorithm.

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

Not applicable, as a clinical study requiring ground truth is not described. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable, as no training set for an algorithm is relevant to this device.

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

Not applicable.

What can be inferred or directly stated from the document:

Device Intended Use/Indications for Use:
- Acceptance Criterion (Implicit): The device functions effectively for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures, and trauma wounds.
- Reported Device Performance (Implicit via substantial equivalence): The device is expected to perform similarly to other silicone gel sheeting products already on the market for these indications. The document states, "The Advanced Medical Solutions Silicone Scar Management Sheet Is essentially similar to other devices approved by the FDA under the device classification. Elastomer, Silicone for scar management."
Predicate Device:
- The predicate device used for comparison is the Spenco Silicone Gel Sheet (510(k) K981902), manufactured by Spenco Medical Corp. The substantial equivalence claim is based on the new device being similar to this already approved device.
Safety Considerations:
- The document implies that the device meets certain safety criteria related to sterilization residuals (ETO: 100ppm, ECH: 100ppm, EG: 2000ppm).
- Warnings and Contraindications: Discontinue use if infection is suspected, not for use on third-degree burns, not to be used on open wounds, not for patients with dermatological conditions that disrupt skin integrity in areas of coverage. These are implicit safety acceptance criteria.

In summary, this document is a regulatory submission focused on substantial equivalence, not a study report detailing specific performance metrics against pre-defined acceptance criteria for a novel clinical trial. It uses an established predicate device as its benchmark for safety and effectiveness.

Summary

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K991630

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JUN 11 1999

Attachment 3

Summary of Safety and Efficacy Summary of Advanced Medical Solutions Silicone Scar Management Sheet

Manufacturer:	Advanced Medical Solutions, Group plcRoad Three, Winsford Industrial EstateCheshire CW7 3FD, United Kingdom
Regulatory Affairs Contact:	Christopher Oakos, Manager
Telephone:	44 1606 863 500
Date Summary Prepared:	May 25th, 1999
Device Trade Name:	Silicone Gel Scar Management Sheet
Common or Usual Name:	Silicone Gel Sheeting
Classification:	Currently unclassified by FDA.
Description:	Advanced Medical Solutions Silicone ScarManagement Gel sheet is a soft, self-adhesive,semi-occlusive sheet made from medical gradesilicone with a polyurethane film backing paper anda non siliconised polyester release paper.
	The primary function of the dressing is to aid in themanagement of both existing and new hypertrophicand keloid scarring on scars resulting from burns,general surgical procedures and trauma wounds.
	The Advanced Medical Solutions Silicone ScarManagement Sheet comes in two sizes 3in. x 4in.and 1in. x 4in. the sheet maybe cut or trimmed tothe desired shape or size prior to placement on thescar, also two or more sheets may be placedtogether to cover a scar area that is greater than thearea of a single sheet.
	The Advanced Medical Solutions Silicone ScarManagement Sheet is self adhesive but can also besecured by a lightly conforming bandage or tape ifso desired.
	The gel sheets are supplied either sterile or non-sterile in foil laminated sterilizable pouches.
Intended Use:	The Advanced Medical Solutions Silicone ScarManagement Sheet intended for the management ofold and new hypertrophic and keloid scarring onscars resulting from burns, general surgicalprocedures and trauma wounds.

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K991630

Residual Limits (Federal Register June 1978)

ETO:	100ppm
ECH:	100ppm
EG:	2000ppm

INTENDED USE AND DIRECTIONS FOR USE

The Advanced Medical Solutions Silicone Scar Management Sheet Intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional.

Not for use on third degree burns.

Not to be used on open wounds.

Not for patients with dermatological conditions which disrupt the integrity of the skin in areas of coverage.

LABELS AND PRODUCT LABELING

Package labeling Is presented in Attachment 1. Currently no promotional literature is available for the device.

r. A STATEMENT INDICATING THE DEVICE IS SIMILAR TO ANDIOR DIFFERENT FROM OTHER PRODUCTS OF COMPARABLE TYPE IN COMMERCIAL DISTRIBUTION. ACCOMPANIED BY DATA TO SUPPORT THE STATEMENT. THIS INFORMATION MAY INCLUDE AN IDENTIFICATION OF SIMILAR PRODUCTS, MATERIALS, DESIGN CONSIDERATIONS. ENERGY EXPECTED TO BE USED OR DELIVERED BY THE DEVICE, AND A DESCRIPTION OF THE OPERATIONAL PRINCIPLES OF THE DEVICE.
The Advanced Medical Solutions Sillcone Scar Management Sheet Is essentially similar to other devices approved by the FDA under the device classification. Elastomer. Silicone for scar management. Predictive devices include Spenco Silicone Gel Sheet 510(k) K981902, Spenco Medical Corp.

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Image /page/2/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 a stylized image of an eagle or bird with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Mr. Christopher James Oakes Regulatory Affairs Manager Advanced Medical Solutions Group plc. Road Three, Winsford Industrial Estate Cheshire CW7 3PD United Kingdom

Re: K991630

Trade Name: Silicone Gel Scar Management Sheet Regulatory Class: Unclassified Product Code: MDA Dated: May 5, 1999 Received: May 11, 1999

Dear Mr. Oakes:

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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

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Page 2 - Mr. Christopher James Oakes

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,

2 Celia 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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Page 1 of 1

510(k) Number (if known): K991630

Device name: Advanced Medical Solutions Silicone Gel Scar Management Sheet

Indications For Usc:

Advanced Modical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of:

Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription The (Per 21 CFR 801.109) OR Over The Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K991630
510(k) Number

Regulation Number and Section

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.