EVANESCE SCAR MANAGEMENT SYSTEM by MEDICAL SCIENTIFIC, INC.

The provided document is a 510(k) premarket notification for the Evanesce Scar Management System, a silicone elastomer sheeting intended for the topical management of hypertrophic and keloid scars. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with acceptance criteria and performance data for the new device itself.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Here's why and what information is present:

510(k) Summary: The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through comparison of indications for use, technological characteristics, and safety and effectiveness information with the predicate.
Predicate Device: The document identifies "SCAR HEAL" (510(k) K971468) from Specialty Systems, Inc. as the predicate device.
Device Description and Intended Use: These are provided for the Evanesce Scar Management System, highlighting it as a sheet of soft, flexible, translucent silicone elastomer for over-the-counter topical treatment of hypertrophic and keloid scars.
FDA Letter: The FDA's letter confirms their review and finding of "substantial equivalence" to devices marketed prior to May 28, 1976, allowing the device to be marketed. This letter signifies regulatory clearance, but it does not detail specific performance studies of the Evanesce system.

To answer your request, if this were a document that contained such information, it would typically look like this (hypothetical example, NOT from the provided text):

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

Performance Metric	Acceptance Criteria	Reported Device Performance
Scar Volume Reduction	≥ 20% reduction in 8 weeks	25.3% reduction (p < 0.001)
Scar Softness Improvement	≥ 1.5-point increase on a 5-point scale	1.8-point increase (p < 0.05)
Adverse Events Rate	< 5% local irritation	3.2% (mild, self-resolving)
Patient Satisfaction	80% of patients report "satisfied" or "very satisfied"	88% reported satisfaction

2. Sample sized used for the test set and the data provenance

Test Set Sample Size: 150 patients
Data Provenance: Prospective, multi-center study conducted in the USA (clinical sites in California, Texas, New York) and Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: 3 independent plastic surgeons.
Qualifications: Each plastic surgeon had at least 15 years of experience in scar management and reconstructive surgery, board-certified in their respective countries (American Board of Plastic Surgery / German Board of Plastic, Reconstructive and Aesthetic Surgery).

4. Adjudication method for the test set

Adjudication Method: 2+1. If two experts agreed on a scar characteristic (e.g., Vancouver Scar Scale rating), that was accepted as ground truth. If all three disagreed or there was a split (e.g., 1-1-1), a fourth, senior plastic surgeon (with 20+ years experience) served as a tie-breaker.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this is a physical device (silicone sheeting) and not an AI or diagnostic imaging system involving human reader interpretation.

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

Not applicable, as this is a physical medical device and does not involve an algorithm.

7. The type of ground truth used

Ground Truth Type: Clinical assessment by expert plastic surgeons using validated scar assessment scales (e.g., Vancouver Scar Scale, Patient and Observer Scar Assessment Scale) and objective measurements (e.g., scar thickness via ultrasound, scar colorimetry). Patient-reported outcomes were also collected.

8. The sample size for the training set

Training set is not applicable for this type of physical device efficacy study. The study involved direct patient application and observation.

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

Not applicable.

In summary, the provided 510(k) document is for regulatory clearance based on substantial equivalence, not a detailed clinical performance study as described in your request.

Summary

{0}------------------------------------------------

JUN 10 1998

Medical Scientific, Inc. 125 John Hancock Blvd. Taunton, MA 02780

13.1

Evansece Scar Management System 510(k) Premarket Notification April 15, 1998

510(k) SUMMARY: K 981387

over the counter use of Evanesce scar management SYSTEM FOR THE TOPICAL MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS.

CONTACT: Paul Nardella Medical Scientific, Inc. 125 John Hancock Rd. Taunton, MA 02780

Tel: 508-880-7313 Fax: 508-880-7347

SPONSOR: 13.2
Medical Scientific, Inc. 125 John Hancock Rd. Taunton, MA 02780

Tel: 508-880-7313 Fax: 508-880-7347

Paul Nardella

DEVICE NAME: -- 13.3

A.) TRADE NAME:

EVANESCE Scar Management System

B.) COMMON NAME:

Silicone Elastomer Sheeting for the treatment and managment of hypertrophic and keloid scars

C.) CLASSIFICATION NAME:

Not Available

Notice: This document is proprietary and its contents are the exclusive property of Medical Scientific, Inc, This document may not be reproduced in any form without the specific permission of Medical Scientific, Inc.

{1}------------------------------------------------

Medical Scientific, Inc. 125 John Hancock Blvd. Taunton, MA 02780

Evansece Scar Management System 510(k) Premarket Notification April 15, 1998

PREDICATE DEVICE: 13.4

SCAR HEAL

Specialty Systems, Inc. 1312 Veracruz Lane Weston FL 33327

510(k) K971468

DEVICE DESCRIPTION 13.5

The Evanesce Scar Management System is composed of a sheet of soft, flexible, translucent silicone elastomer.

INTENDED USE: 13.6

The Evanesce Scar Management System is intended for the over the counter, topical treatment and management of hypertrophic and keloid scars. Do not use on open wounds.

PAGE-11-

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1998

Mr. Paul C. Nardella ·Medical Scientific, Incorporated 125 John Hancock Road Taunton, Massachusetts 02780

Re: K981387 Evanesce Scar Management System Trade Name: Regulatory Class: Unclassified Product Code: MDA Dated: April 14, 1998 Received: April 16, 1998

Dear Mr. Nardella:

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 reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and pronibitions 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 Requlations, Title 21, Parts 800 to 895. ਸ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

{3}------------------------------------------------

Page 2 - Mr. Paul C. Nardella

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,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page

510(k) Number (if known):K981387

Device Name: Evanesce Scar Management System

Indications for Use:

The Evanesce Scar Management System is intended for the over the counter topical management of Hypertrophic and Keloid Scars

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Acedo

ign-Off) on of General Restorative Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(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.