PMT NEW BEGINNINGS GELSHAPES & AMEND by PMT CORP.

PMT®'s Model 5100 New Beginnings™ GelShapes™ & Amend™ consist of a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing. Certain GelShapes™ & Amend™ also have reinforcement material for added strength. The silicone gel sheeting is used on hypertrophic or keloid scars in order to soften or lighten the color of these scars. The model 5100 New BeginningsTM GelShapes™ & Amend™ are used only externally and on intact skin.

AI/ML Overview

The provided text is a 510(k) premarket notification for the PMT® New Beginnings™ GelShapes™ & Amend™ device, which is a silicone gel sheeting used for the management of hypertrophic and keloid scars. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with acceptance criteria, human reader studies, or detailed ground truth methodologies typically associated with software-as-a-medical-device (SaMD) or AI-powered devices.

Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample sizes, expert qualifications, adjudication, MRMC, standalone performance), and detailed ground truth establishment is not present in this 510(k) submission.

Here's an attempt to answer the questions based on the available information, noting when the information is not provided:

Acceptance Criteria and Study for PMT® New Beginnings™ GelShapes™ & Amend™

This 510(k) submission (K972597) for the PMT® New Beginnings™ GelShapes™ & Amend™ device demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria through clinical studies in the way an AI/software device would. The "study" here refers to the documentation and claims made within the 510(k) to support this substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as such for this 510(k))	Reported Device Performance
Premarket Notification (510(k)) Goal: Substantial Equivalence to Predicate Devices	The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or to reclassified devices. This implies that the device performs similarly to or has the same intended use as predicate gel sheeting products (e.g., ReJuveness, McGhan Medical Corporation, Geligne Medical, Medical Z, CUI Corporation, Biodermis).
Intended Use: Management of hypertrophic and keloid scars	The device's stated "Indications For Use" is "Management of hypertrophic and keloid scars." This matches the indication of predicate devices.
Device Description: Solid low durometer medical-grade silicone with thin, high durometer silicone backing, some with reinforcement. Used externally on intact skin.	The device consists of "a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing." Certain variations have "reinforcement material for added strength." This description aligns with the physical characteristics expected of gel sheeting for scar management, similar to predicate devices.
Sterilization: Overkill method to 10⁻⁶ SAL (if sterile)	"The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a nonsterile unit of 10⁻⁶." This meets standard sterilization validation practices.

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

Sample Size (Test Set): Not applicable or not specified. This 510(k) submission does not describe a specific clinical "test set" or study on patients to evaluate performance against acceptance criteria. The submission relies on the established use and safety profile of similar predicate devices.
Data Provenance: Not applicable, as no new clinical data from a "test set" is presented in the summary for performance evaluation. The submission refers to "a number of different articles within this submission" regarding the common procedure of managing scars with gel sheeting, implying existing literature, but does not detail a specific new study's data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As there is no specific "test set" and ground truth validation study described in the 510(k) summary, no experts were detailed for this purpose.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process is described in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study was not conducted for this 510(k) submission. This is a medical device (silicone sheeting), not an AI/software diagnostic tool that would typically involve MRMC studies to evaluate human reader performance with and without AI assistance.

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

Not applicable. This device is a physical product (gel sheeting), not an algorithm or software. It does not have "standalone" algorithm performance. Its efficacy is based on its physical properties and interaction with biological tissue for scar management, likely supported by general understanding and existing literature on silicone gel sheeting.

7. The Type of Ground Truth Used

Not explicitly defined. For a physical device like silicone gel sheeting, "ground truth" for efficacy would typically be established through clinical outcomes (e.g., blinded assessments of scar appearance, pliability, color, patient reported outcomes) in well-designed clinical trials. This 510(k) relies on the "common procedure" and "equivalence" to predicate devices whose efficacy is presumably well-established clinically. No specific ground truth methodology for a new study is detailed here.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no "training set" in the computational sense.

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

Not applicable. No training set exists for this device.

Summary

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97257

061 - 1 991 510(k) Notification New Beginnings™ GelShapes™ & Amend™ July 8, 1997

PMT® Corporation

Premarket Notification [510(k)]		Summary
Submitters name:	PMT CORPORATION
Submitters Address:	PMT Corporation1500 Park RoadChanhassen, MN 55317
Phone:	(612) 470-0866
Fax:	(612) 470-0865
Contact name:	Steve Trinter
Date:	July 8, 1997
Trade name:	PMT® New Beginnings™ GelShapes™ & Amend™
Common name:	Gel Sheeting

lassification name:

Equivalent device(s):

ReJuveness, McGhan Medical Corporation, Geligne Medical, Medical Z, CUI Corporation, Biodermis produce equivalent devices to those offered by PMT Corp.

Device Description:

This is a product which is commonly used by physicians treating hypertrophic or keloid scars, but is also now available at pharmacies and through direct phone orders.

While May of keloid and hypertrophic scars by gel sheeting is a common procedure that has been around for many years, we have included a number of different articles within this submission for the reviewer.

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The PMT New Beginnings™ GelShapes™ & Amend™ are packaged in a pouch constructed of Tyvek and Mylar. The package will employ a chevron opening feature.

The PMT New Beginnings™ GelShapes™ & Amend™ are provided sterile or nonsterile. The type of sterilization is 100% Ethylene Oxide. The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a nonsterile unit of 10-6.

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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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird figure. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 1 1997

Mr. Steve Trinter .General Manager, Plastic Surgery Products Divison PMT® Corporation 1500 Park Road Chanhassen, Minnesota 55317

Re: K972597

Trade Name: PMT® New Beginnings™ GelShapes™ & Amend™ Regulatory Class: Unclassified Product Code: MDA Dated: July 8, 1997 Received: July 11, 1997

Dear Mr. Trinter:

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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. Steve Trinter

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,

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
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K972597 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name PMT New Beginnings™ GelShapes TM and AmendTM

Indications For Use:

13 : . . . . . . . . .

Management of hypertrophic and keloid scars.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

bcoll
(Division Sign-Off)
Division of General Restorative Devices K972597
510(k) Number

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)

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.