The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm'), like other OTC devices for hair removal. It also uses low RF energy (output 0.4-0.8 J/cm²) delivered through the RF electrodes. The RF signal serves primarily as a safety means to ensure skin contact before the IPL pulse is emitted. The only changes made in the current version compared to the previously cleared device relate to a minor electronics and software update, and ergonomic enhancements to the applicator and base unit control panel. All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Syneron Beauty Ltd.'s mê device:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Substantial equivalence is established by showing that the new device has the same intended use, similar technological characteristics, and does not raise new safety or effectiveness questions compared to a legally marketed predicate device.

Therefore, the document does not contain the level of detail typically found in a clinical study report that establishes performance metrics against predefined acceptance criteria for a de novo device.

Despite this, I will extract the information that is present and highlight what is missing based on your request.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from Testing)	Reported Device Performance
Non-Clinical Testing	Electrical safety standards met	"modified me device functioned as intended"
	Electromagnetic compatibility standards met	"modified me device functioned as intended"
	Software verification/validation successful	"modified me device functioned as intended"
	System verification/validation successful	"modified me device functioned as intended"
Clinical Performance	Not explicitly defined or reported in terms of specific hair reduction percentages or adverse event rates as acceptance criteria.	Not applicable in this context. The claim is substantial equivalence to a predicate device for hair removal, which previously established itself as effective.

Explanation: The document strongly emphasizes that "All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged" compared to the predicate. The "performance data" section refers to non-clinical testing to re-validate the updated version. This means the acceptance criteria were that the updated device would perform identically to the predicate device in these non-clinical aspects.

Detailed Breakdown of Study Information (Based on the Provided Text):

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

Sample Size for Test Set: Not applicable. The "performance data" discussed refers to non-clinical engineering and software testing of the device itself (e.g., electrical safety, EMC, software V&V, system V&V), not a clinical test set of patients.
Data Provenance: Not applicable, as this was non-clinical engineering testing.

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. Ground truth for clinical efficacy or safety was not established for this submission as it relies on the predicate device's prior establishment. The testing mentioned (electrical, EMC, software, system) would involve engineers and testers confirming adherence to technical specifications and standards.

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

Not applicable. No clinical test set or adjudication process 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

No. This is not an AI/software as a medical device (SaMD) submission involving human readers or comparative effectiveness for image interpretation. It's a re-submission for a physical device with minor updates based on substantial equivalence.

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

Not applicable. This is not a software-only device. The "software verification and validation testing" refers to the embedded software within the physical device, not a standalone algorithm for diagnostic or prognostic purposes.

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

For the non-clinical tests: The "ground truth" was adherence to established engineering standards (e.g., for electrical safety, EMC) and the functional specifications of the device's software and system.
For the overall device's indication of hair removal effectiveness: The ground truth would refer to the data previously submitted and accepted for the predicate device (K121598), which established the efficacy of the underlying technology for hair removal. This current submission relies on the predicate's established effectiveness and safety.

8. The sample size for the training set

Not applicable. This device does not use machine learning that requires a "training set" in the conventional sense. The "software verification and validation testing" refers to standard software development lifecycle testing, not AI model training.

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

Not applicable, as there is no training set for a machine learning model.

Summary of what the document does provide:

The 510(k) submission for the Syneron Beauty Ltd.'s mê device (K123845) is focused on demonstrating substantial equivalence to its predicate device (K121598). The changes in the current version are described as "minor electronics and software update, and ergonomic enhancements."

To support substantial equivalence, the submission references the following non-clinical performance testing:

Electrical safety
Electromagnetic compatibility testing
Software verification and validation testing
System verification and validation testing

These tests were conducted to re-validate the updated device against the same test methods and criteria used on the predicate device. The reported outcome is that "In all instances, the modified me device functioned as intended," meaning it met the technical and safety standards required for such a device and performed comparably to the predicate for these non-clinical aspects.

The document explicitly states that "The modified me device has the same intended uses and same indications as the predicate. The technological characteristics and principles of operation are also very similar to its predicate device. The minor differences in aesthetics, software and electronics between the modified device and its predicate device do not raise any new types of safety or effectiveness questions..." This is the core argument for its acceptance under the 510(k) pathway.

Summary

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<123845

510(k) SUMMARY

JAN 1 0 2013

Syneron Beauty Ltd.'s mê

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Syneron Beauty Ltd. Kochav Yokneam Bldg. Yokneam Industrial Zone P.O Box 14

Yokneam Illit 20692 Israel

Phone: +972 (4) 9098 700 Facsimile: +972 (4) 9098 701

Contact Person: Omri Hayet

Date Prepared: December 12, 2012

Name of Device and Name/Address of Sponsor

mē

Syneron Beauty Ltd.

Kochav Yokneam Bldg. Yokneam Industrial Zone P.O Box 14 Yokneam Illit 20692 Israel

Common or Usual Name

Light based hair removal system

Classification Name

ONF- Laser surgical instrument for use in general and plastic surgery and in dermatology

Predicate Devices

mē (K121598)

Intended Use / Indications for Use

The me is an over-the counter device intended for the removal of unwanted hair.

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123845
Page 2 of 2

Technological Characteristics

Performance Data

The following non-clinical performance testing was conducted to re-validate the updated version of the me device compared against the same test methods and criteria used on the predicate device cleared in K121598.

Electrical safety .
Electromagnetic compatibility testing .
Software verification and validation testing .
System verification and validation testing ●

In all instances, the modified me device functioned as intended.

Substantial Equivalence

The updated model of the me device is as safe and effective as the me (K121598). The modified me device has the same intended uses and same indications as the predicate. The technological characteristics and principles of operation are also very similar to its predicate device. The minor differences in aesthetics, software and electronics between the modified device and its predicate device do not raise any new types of safety or effectiveness questions, as confirmed by software verification and validation, electrical safety, and electromagnetic compatibility/interference testing. No changes in materials resulted from the minor device modifications. Performance data demonstrate that the modified me device performs as expected. Thus, the modified me device is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a common symbol for health and well-being.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: January 10, 2013

Syneron Beauty, Limited % Hogan Lovells US, LLP Ms. Janice M. Hogan Regulatory Counsel 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K123845

Trade/Device Name: mē Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF

Dated: December 13, 2012 Received: December 13, 2012

Dear Ms. Hogan:

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 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

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Page 2 - Ms. Janice M. Hogan

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.

Mark N. Melkerson

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

Enclosure

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Indications for Use

510(k) Number (if known): K123845

Device Name: me

Indications For Use: The me is an over-the-counter device intended for the removal of unwanted hair.

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

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

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

Neil R Ogden 2013.01.10 10:55:14 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number_

Page 1 of _

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.