The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.

Device Description

The Silk'n HST device is designed as a hand held device, which utilizes both RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n HST device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch that also selects the energy level as manifested using indicators panel. The adaptor connects the applicator to the electrical outlet using its plug and the applicator socket.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: Silk'n HST
Intended Use: Over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for effectiveness appears to be a statistically significant reduction of at least 1.0 score in the average score of the Fitzpatrick Wrinkle Severity Scale, according to at least 2 out of 3 blinded dermatologists, measured 3 months post-treatment end compared to baseline.

Acceptance Criterion	Reported Device Performance
Effectiveness:
Statistically significant reduction of at least 1.0 score in average Fitzpatrick Wrinkle Severity Scale score.	Achieved an average statistically significant reduction of 1.49 ± 0.51 Fitzpatrick scores (p<0.001).
Reduction determined by at least 2 out of 3 blinded dermatologists.	Downgrade of at least 1 score seen in: - Reviewer #1: 96.67% (29/30) - Reviewer #2: 90.0% (27/30) - Reviewer #3: 93.33% (28/30) - ≥2 agree: 100% (30/30)
Safety:	No unexpected adverse events detected. Treatment associated with no to merely mild pain.
Usability / User Satisfaction:	All 30 study participants were (very or somewhat) satisfied with the ease of learning to use the device. 86% (26/30) of patients were satisfied to very satisfied with overall device performance. 97% (29/30) indicated some improvement in wrinkle status.
Self-selection and Labeling Comprehension:	100% success rate in self-selection study (25 subjects). 100% success rate in labeling comprehension test (20/20 patients found it easy to understand instructions). 100% of eligible subjects successfully performed device-related tasks with minimal assistance.

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

Sample Size for Effectiveness Study (Test Set): 30 eligible adults (N=30, completer case analysis).
Sample Size for Usability/Self-Selection Study (Test Set):
- Self-selection: 25 subjects.
- Usability/Labeling Comprehension: 20 subjects (from the 25, implying 5 were excluded due to contraindications).
Data Provenance: The clinical study was conducted at a certified clinic in the US. The text does not explicitly state whether it was retrospective or prospective, but the description of the study design ("included 21 treatment sessions every other day, over a period of 6 weeks, and 2 maintenance treatments," "3 months following treatment end") strongly suggests a prospective study.

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

Number of Experts: 3 blinded dermatologists.
Qualifications of Experts: They are referred to as "blinded dermatologists," indicating a medical specialization relevant to skin conditions and aesthetic evaluation. No specific experience (e.g., years) is mentioned.

4. Adjudication Method for the Test Set

The effectiveness criterion explicitly states "according to at least 2 out of 3 blinded dermatologists." This indicates a 2/3 majority consensus adjudication method for determining success on the Fitzpatrick scale.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This study focused on the effectiveness of the device itself (AI is not mentioned here as assisting human readers, rather the device is the treatment).

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

This device is a physical, home-use treatment device (combining RF and LED energies) for wrinkles, not an AI algorithm. Therefore, the concept of a "standalone algorithm-only performance" does not apply in the context of this submission. The performance measured is that of the device's effect on patients.

7. The Type of Ground Truth Used

The ground truth for effectiveness was established by expert consensus (at least 2 out of 3 blinded dermatologists) using the Fitzpatrick Wrinkle Severity Scale. User satisfaction and usability were derived from subject questionnaires and observed task performance.

8. The Sample Size for the Training Set

The document does not mention any "training set" in the context of machine learning or AI models. This device is a physical energy-based device, not a software algorithm that requires a training set. The clinical study described served as the primary test set for the device's safety and effectiveness.

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

As there is no mention of an AI algorithm or a training set, this question is not applicable. The device's performance was evaluated through a clinical study where outcomes were assessed by blinded dermatologists and participant feedback.

Summary

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

March 25, 2017

Home Skinovations Ltd. % Mr. Amit Goren A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 44425 Israel

Re: K162784 Trade/Device Name: Silk'n HST 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: OHS, PAY Dated: February 15, 2017 Received: February 21, 2017

Dear Mr. Goren:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K162784

Device Name Silk'n HST

Indications for Use (Describe)

The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY SILK'N HST 510(k) Number K162784

Applicant:	Home Skinovations Ltd.Tavor Building, POB 533Yokneam Iillit 2069206 IsraelTel: +972(4)9097440 Fax: +972(4)9097471E-mail: amit@asteinrac.com; ahava@asteinrac.com
Contact Person:	Amit GorenA. Stein - Regulatory Affairs Consulting Ltd.20 Hata'as Str., Suite 102Kfar Saba 44425 IsraelTel: + 972-9-7670002 Fax: +972-9-7668534E-mail: amit@asteinrac.com; ahava@asteinrac.com
Date Prepared:	March 22, 2017
Trade Name:	Silk'n HST
Classification Name:	21 CFR Classification sections 878.4810 and 878.4420; Productcodes OHS and PAY, respectively.
Classification:	Class II Medical Device

Predicate Device

The Silk'n HST device is substantially equivalent to the previously cleared Silk'n FX device, also manufactured by the applicant (Home Skinovations Ltd.). In addition, the Newa"M device is used as a reference predicate.

Manufacturer	Device	510(k) No.
Home Skinovations Ltd.	Silk'n FX	K110301
EndyMed Medical Ltd.	NewaTM	DEN150005

Device Description

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Device Specifications:

Optical power density:	55 and 70mW/cm2 (±10%)
RF frequency:	1MHz
RF power density:	10W±20%
Input Voltage (nominal):	90-264 VAC
Main Line Frequency (nominal):	47-63 Hz

Intended Use/Indication for Use

The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.

Performance Standards

The Silk'n HST device has been tested and complies with the following voluntary recognized standards:

#	Standard	Description
1	IEC 60601-1:2005 (3rd edition) +C1:2006 + C2:2007 + Amendment1:2012 or IEC 60601-1: 2012(reprint)	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance
2	IEC 60601-1-2:2007 (3rd & 4th editions)	Medical electrical equipment;Part 1-2: Collateral Standard: Electromagneticcompatibility - Requirements and tests
3	IEC 60601-2-2:2009 (5th edition)	Medical electrical equipment;Part 2-2: Particular requirements for the basic safetyand essential performance of high frequency surgicalequipment and high frequency surgical accessories
4	IEC 60601-1-6:2010 (3rd edition) +A1:2013	Medical electrical equipment Part 1 6 Generalrequirements for basic safety and essentialperformance Collateral Standard Usability
5	IEC 62366:2007 + A1:2014	Medical device - Application of Usabilityengineering to medical devices
6	IEC 60601-1-11:2015 (2nd edition)	Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Requirements formedical electrical equipment and medical electricalsystems used in the home healthcare environment
7	IEC 60601-2-57:2011 (First edition) foruse in conjunction withIEC 60601-1:2005	Medical electrical equipment - Part 2-57: Particularrequirements for the basic safety and essentialperformance of non-laser light source equipmentintended for therapeutic, diagnostic, monitoring andcosmetic/aesthetic use

Non-Clinical (Bench) Performance Data

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The Silk'n HST device was evaluated in a set of performance tests for its conformity with the design requirements specifications and for its optical and RF parameters and temperature profile. The testing included over-heating safety, parameter validation and power accuracy.

Furthermore, the Silk'n HST device underwent software validation testing as well as was tested and found to comply with the Electrical and mechanical safety standard (IEC 60601-1), the electromagnetic compatibility standard (IEC 60601-1-2), the non-laser light source equipment standard (IEC 60601-2-57), the medical electrical equipment standard (IEC 60601-1-11) and the particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2).

The results of the tests demonstrated that all of the device specifications met the system requirements and do not raise new safety or effectiveness concerns.

Animal Performance Data / Histology Data

Not Applicable

Clinical Performance Data

Safety & Effectiveness

In order to validate the safety and efficacy of the RF and optical LED combination, a clinical study was conducted at a certified clinic in the US in 30 eligible adults. The study included 21 treatment sessions every other day, over a period of 6 weeks, and 2 maintenance treatments that were performed 1 and 2 months following treatment sessions ended. The criterion for study success was a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick scale score according to at least 2 out of 3 blinded dermatologists, as measured 3 months following treatment end compared to baseline. The study results indicate that the combination of RF and optical light energies produces on average a statistically significant reduction of 1.49±0.51 Fitzpatrick scores as compared with baseline to 3-month follow-up (p<0.001), as determined by 3 blinded evaluators. According to the study, downgrade of at least 1 score on the Fitzpatrick Wrinkle Severity Scale score was seen in 96.7%, 90.0%, and 93.3% of the patients, as reported by the first, second and third reviewers, respectively (results are summarized in Table 1.0 below) During the study, no unexpected adverse events were detected and the treatment was associated with no to merely mild pain. Usability parameters were tested as well and indicated precise operation and safe use.

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Table 1.0:Effectiveness results calculated based oncompleter case (N=30)
Reviewer #1	96.67% (29/30)
Reviewer #2	90.0% (27/30)
Reviewer #3	93.33% (28/30)
≥2 agree	100% (30/30)

At the last follow-up visit, participants were asked a series of questions designed to explore the level of satisfaction regarding the device operation and treatment results. A score of 5 was defined as "Very Satisfied" while a score of 1 was "Very dissatisfied."

All study participants were (very or somewhat) satisfied with the ease of learning to use the Silk'n HST device. The data from this satisfaction questionnaire show that subjects were generally satisfied with the Silk'n HST device, where 86% of the patients (26/30) were satisfied to very satisfied with the overall device performance The vast majority of participants (29/30, 97%) indicated that there was some improvement in their wrinkle status.

Usability, Self-selection & Labeling Comprehension

In addition, a separate usability study was conducted, demonstrating that the Silk'n HST labeling materials were understandable and adequately acknowledged for the self-selection. Twenty five subjects had participated in the self-selection study with 100% success rate. Twenty of them had successfully identified themselves as potential device users and five subjects, which were deliberately contraindicated to the study inclusion criteria, had successfully self excluded from study participation.

All of the eligible 20 study subjects succeeded to perform the device related tasks, with minimal number of requests for assistance and with no errors or inefficiencies. The average time to completion of tests was 36.1 minutes. The only error that was deliberately initiated by the observer (electrical failure) was easily detected and resolved by the user. The results of the post treatment questionnaire showed that all of the patients (20/20) were comfortable with the device operation and with the ease in labeling comprehension. The labeling comprehension test indicate on a good experience of the potential users with a success rate of 100%, where all of the patients (20/20) found it easy to understand the instructions for use and perform the tasks related to treatment. These results show that the user understood the information on the device labeling, and the major communication messages that detail the safe and effective use of the device.

This study also demonstrated that the device is easy to operate by potential endusers and safe under actual use conditions.

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Substantial Equivalence

The Silk'n HST device is an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of periorbital wrinkles. The main predicate device, Silk'n FX, is also a non-invasive, non-ablative device that was cleared with the indication for use of periorbital wrinkles treatment. The predicate device utilizes optical energy with the same wavelengths and other optical characteristics as the Silk'n HST device.

The design and components of the Silk'n HST device are similar to the design and components of the Silk'n FX device. The major modifications made to the Silk'n HST device are the addition of RF energy and an addition of adaptor as a substitute to the rechargeable batteries and charging cradle. The inclusion of RF energy was conducted according to a reference predicate device, Newa™, which is FDAcleared, over-the-counter, non-invasive, non-ablative device, utilizing RF energy for the treatment of full-face wrinkles. Both the Newa™ and Silk'n HST devices apply 1MHz RF with the same output power, thus sharing the same RF-related technological parameters, which imply similar underlying mechanism of action.

All the safety features that are embedded in the Silk'n FX, namely - safety proximity sensor, temperature sensor and software protection from abnormalities are identically included in the Silk'n HST. Two additional safety features, which are related to RF energy and stem from the Newa™ device, were incorporated in the Silk'n HST. These additional safety features include a visual user interface with indicator LEDs for device status and a built-in timer that stops the RF delivery at the end of the treatment session.

All the features embedded in the Silk'n HST device are identical to those of the predicate devices. The supporting bench performance testing and clinical data indicate that the combination of both energies is safe and effective for the device intended use.

Consequently, it can be concluded that the Silk'n HST device is substantially equivalent to the main predicate Silk'n FX device, cleared under 510(k) K110301, and to the reference predicate Newa"" device, cleared under de novo DEN150005.

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.