EndyMed's Fractional Skin Resurfacing (FSR) Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346). The FSR Applicator tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.

AI/ML Overview

The provided text describes the EndyMed Fractional Skin Resurfacing (FSR) Applicator and its 510(k) submission. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a detailed study.

The document states that a "performance testing" was conducted and its results "clearly indicate that the Fractional Skin Resurfacing (FSR) Applicator offers a non-invasive, effective, safe device for skin resurfacing." It also claims the device "is as safe, as effective, and performs at least as safely and effectively as the legally marketed device" (predicate devices).

Here's a breakdown based on the information provided, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Non-invasive, effective, safe for skin resurfacing. Performs at least as safely and effectively as predicate devices.

Missing Information: The document does not explicitly state specific quantitative or qualitative acceptance criteria (e.g., minimum percentage improvement in skin texture, reduction in wrinkles, safety endpoint thresholds). It only provides a general statement about the device's performance relative to safety and efficacy.

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

Missing Information: The document states "a performance testing" was conducted but does not provide any details on:

The sample size of participants or data points used in the test set.
The country of origin for the data.
Whether the study was retrospective or prospective.

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):

Missing Information: The document mentions "performance testing" but does not describe how ground truth was established, nor does it refer to any experts involved in this process or their qualifications.

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

Missing Information: There is no information provided about any adjudication method used for establishing ground truth or evaluating the test results.

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 (Based on available information): This device is an applicator for dermatological procedures (physical treatment), not an AI-assisted diagnostic device that would involve human readers interpreting results with or without AI. Therefore, an MRMC study related to AI assistance for human readers is not relevant in this context.

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

Not Applicable (Based on available information): Similar to point 5, this is a physical treatment device, not an algorithm. Standalone performance (algorithm-only) is not applicable here. The device's performance inherently involves a human operator.

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

Missing Information: The document does not specify the type of ground truth used for evaluating the device's performance. Given it's a skin resurfacing device, potential ground truths could include clinical assessment scores (e.g., wrinkle scales, skin texture scores), photographic assessment, or potentially histological changes, but none are mentioned.

8. The sample size for the training set:

Missing Information: As the device is not an AI algorithm, there is no "training set" in the conventional sense. The "performance testing" described is likely a clinical trial or study on human subjects, not an algorithm training process.

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

Missing Information: As there is no AI algorithm training set, this question is not applicable.

Summary

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FEB 17 2011

510(K) SUMMARY

Fractional Skin Resurfacing (FSR) Applicator 510(k) Number K101510

Applicant's Name:	EndyMed Ltd
	7 Bareket Street,
	North Industrial Park,
	Caesarea, 30889 Israel
	Tel: (972)4-630-9100
	Fax: (972)4-630-9101
Contact Person:	Yoram Levy, Qsite
	31 Haavoda Street
	Binyamina, Israel 30500
	Tel (972)4-638-8837; Fax (972)4-638-0510
	Yoram@qsitemed.com

Trade Name:	Fractional Skin Resurfacing (FSR) Applicator
Preparation Date:	April 29, 2010
Classification:	Name: Electrosurgical, cutting & coagulation device& accessories
	Product Code: OUH
	Regulation No: 21 CFR 878.4400
	Class: IIPanel: General and Plastic Surgery

Device Description:

Intended Use Statement:

The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin

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Predicate Devices: Substantial equivalence to the following predicate devices is claimed:

Device Name	510k No	Date of Clearance
Syneron Matrix RFApplicator	K073572	Sep 17, 2008
EndyMed Imagine TC SkinTreatment System	K083461	Jul 24, 2009

Performance Standards:

Fractional Skin Resurfacing (FSR) Applicator complies with

EN 60601-1 (Medical Electrical Equipment-Part 1: General . Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
IEC 60601-1-2 (Electromagnetic compatibility (EMC) .
ANSI AAMI 60601-2-2 for safety of high frequency surgical ● equipment.

A detailed description appears in Section 14.

Summary of Clinical performance data:

The safety and efficacy of the Fractional Skin Resurfacing (FSR) Applicator was evaluated in a performance testing.

The results of this testing clearly indicate that the Fractional Skin Resurfacing (FSR) Applicator offers a non-invasive, effective, safe device for skin resurfacing.

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Image /page/2/Picture/0 description: The image shows the logo for EndyMed, a company specializing in 3DEEP technology. The logo features the company name in a bold, sans-serif font, with the letters slightly spaced apart. To the left of the name is a pattern of dots arranged in a grid-like formation. Below the company name, in a smaller font, is the tagline "THE 3DEEP COMPANY".

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Conclusion

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The performance tests demonstrate that the Fractional Skin Resurfacing (FSR) Applicator is as safe, as effective, and performs at least as safely and effectively as the legally marketed device.

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Image /page/3/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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines above a wavy base.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

EndyMed Medical, Ltd. % Osite Yoram Levy 31 Haavoda Street Binyamina 30500 Isracl

FEB 17 200

Re: K101510

Trade/Device Name: Fractional Skin Resurfacing (FSR) Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: OUH Dated: January 21, 2011 Received: January 31, 2011

Dear Yoram Levy:

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 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. 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

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Page 2 - Yoram Levy

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kiz B. Rhr
fer

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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k/0/5/0

Image /page/5/Picture/1 description: The image shows the logo for EndyMed, a company that specializes in 3DEEP technology. The logo features a grid of dots on the left, followed by the company name in a bold, sans-serif font. Below the company name is the tagline "THE 3DEEP COMPANY" in a smaller font. The logo is simple and modern, and it effectively communicates the company's focus on advanced technology.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Fractional Skin Resurfacing (FSR) Applicator

Indications for Use:

The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin

Use X Prescription (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number

Nathalie Olson Forman
Division Sign Off

Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number. K101510

EndyMed Fractional Skin Resurfacing (FSR) Applicator - 510k Notification

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.