The Silk'n Infinity is an over the counter device intended for the removal of unwanted hair. The Infinity device is also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Silk'n Infinity electric output is indicated for facial stimulation for over-the-counter aesthetic use.

Device Description

The Silk'n Infinity device is designed as a hand held, home use device, which utilizes Intense Pulsed Light (IPL) for hair removal and galvanic microcurrents for skin stimulation. The device comprises a power adaptor and device applicator. The applicator consists of a single lamp producing the light energy that is emitted via the flash window, and a chrome-coting stripe (touch electrode) located around the flash window, through which the micro-current pulses are discharged. The applicator spot size is 2.7cm2 The user interface located on the applicator contains ON/OFF button, pulsed trigger button and six green LED indicators which provide information on the energy level, system status & errors. The Silk'n Infinity device contains a skin sensor, providing the user with an additional safety measure to detect appropriate skin tones and a proximity sensor that identifies full contact with the skin before pulse activation. The light output power range is from 3 to 5 J/cm 2, the optical filter cut off wavelength is 475-1200nm.

AI/ML Overview

This document is a 510(k) summary for the Silk'n Infinity device, which is an over-the-counter device intended for hair removal and facial stimulation. The focus of this document is to demonstrate "substantial equivalence" to predicate devices, rather than to prove performance against specific acceptance criteria for a novel device through a formal study.

Therefore, many of the typical elements of an AI/ML device study described in the prompt (e.g., test set sample size, number of experts, MRMC studies, standalone performance, ground truth establishment) are not applicable or not present in this document.

The document primarily focuses on:

Bench testing: Verifying output parameters and safety in simulated home-use settings.
Compliance with recognized standards: Showing the device meets established electrical, mechanical, and safety standards for medical electrical equipment.
Substantial Equivalence Argument: Comparing the Silk'n Infinity to legally marketed predicate devices (Silk'n Glide for IPL hair removal and Facial Spa for microcurrent facial stimulation) based on similar technology, intended use, and safety features.

Here's an attempt to answer the questions based only on the provided text, acknowledging that many questions relate to performance studies that were not conducted or detailed in this 510(k) summary:

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

The document does not present a formal table of acceptance criteria for a device's performance against clinical endpoints like hair reduction efficacy or skin stimulation effectiveness, nor does it provide reported device performance data in that format. Instead, the acceptance is based on:

Acceptance Criterion (Implicit)	Reported Device Performance
IPL Output Performance: Match predicate device (Silk'n Glide) specifications.	"The Silk'n Infinity device, IPL optical output performance specifications are based on the same performance specifications as those of the main predicate, the Silk'n Glide which were already evaluated and well established in K131870 & K141242." Specific values are given for predicate: Light Output Power 3-5 J/cm², Pulse duration 500-800 µsec, Wavelength 475-1200nm.
Microcurrent Output Performance: Comply with design requirements and align with reference predicate (Facial Spa).	"The test results demonstrated that the output parameters complied with the device design requirements and were in line with the reference predicate output specifications." Specific values for the device are: Maximal output current 420 μA, Maximal output voltage 210 mv & 840 mv.
Safety in Simulated Home Use: Safe for intended use.	"The test results showed that the device was safe for use as intended."
Software Validation: Met system requirements.	"The Silk'n Infinity device underwent software validation testing as well as was tested and found to comply with..." "These performance tests demonstrated that the device specifications met the system requirements..."
Compliance with Electrical & Mechanical Safety Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 60601-1-11, IEC 60601-2-10	"The Silk'n Infinity device has been tested and complies with the following voluntary recognized standards:" (lists all mentioned standards). "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."
Biocompatibility: Comply with ISO 10993-1.	"All patient contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard."

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: For the "simulated home use settings" safety test, the sample size was eight human volunteers.
Data Provenance: The document does not explicitly state the country of origin for the volunteers. The study was a "bench test" described as evaluating device safety in a simulated home use setting, implying a prospective test conducted for this submission.

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

This information is not provided in the document. The "simulated home use settings" test was a safety test, not a performance study requiring human "ground truth" for disease detection or similar tasks.

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

This information is not applicable/provided. The described tests are bench and safety performance tests, not clinical efficacy studies requiring adjudication of outcomes or diagnoses.

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 MRMC comparative effectiveness study was done or reported in this document. This device is not an AI/ML diagnostic or assistive tool for human readers.

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

This information is not applicable/provided. This device is a direct-use medical device (IPL hair removal and microcurrent stimulation), not an algorithm. Bench tests were performed on the device itself to verify output and safety parameters.

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

For the safety test on human volunteers, the "ground truth" would be the direct observation of adverse events or lack thereof, relative to device parameters. For the technical specifications, the ground truth is established by engineering measurements against predetermined design requirements and compliance with recognized standards.

8. The sample size for the training set:

Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is not an AI/ML algorithm.

Summary

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

August 11, 2017

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

Re: K171433

Trade/Device Name: Silk'n Infinity 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: OHT Dated: May 10, 2017 Received: May 15, 2017

Dear Amit 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

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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 devicerelated 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 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,

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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510(K) SUMMARY SILK'N INFINITY 510(k) Number K171433

Applicant:	Home Skinovations Ltd.Tavor Building, POB 533
	Yokneam Iillit 2069206 Israel
	Tel: +972(4)9097440
	Fax: +972(4)9097471
	E-mail: amit@asteinrac.com;
Contact Person:	Amit Goren
	A. Stein - Regulatory Affairs Consulting Ltd.
	20 Hata'as Str., Suite 102
	Kfar Saba 44425 Israel
	Tel: + 972-9-7670002
	Fax: +972-9-7668534
	E-mail: amit@asteinrac.com
Date Prepared:	August 08, 2017
Trade Name:	Silk'n Infinity
Classification Name:	21 CFR Classification sections 878.4810 and 882.5890; Productcodes OHT, ONF and NFO.
Classification:	Class II Medical Device

Predicate Device

The Silk'n Infinity device is substantially equivalent to the previously cleared Silk'n Glide device (Main predicate), also manufactured by the applicant (HomeSkinovations Ltd.). In addition, the Facial Spa device is used as a reference predicate.

Manufacturer	Device	510(k) No.
Home Skinovations Ltd.	Silk'n Glide	K141242
Nu Skin Enterprises Inc.	Facial SPA	K122711

Device Description

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consists of a single lamp producing the light energy that is emitted via the flash window, and a chrome-coting stripe (touch electrode) located around the flash window, through which the micro-current pulses are discharged. The applicator spot size is 2.7cm2 The user interface located on the applicator contains ON/OFF button, pulsed trigger button and six green LED indicators which provide information on the energy level, system status & errors. The Silk'n Infinity device contains a skin sensor, providing the user with an additional safety measure to detect appropriate skin tones and a proximity sensor that identifies full contact with the skin before pulse activation. The light output power range is from 3 to 5 J/cm 2, the optical filter cut off wavelength is 475-1200nm.

Device Specifications:

Intense Pulsed Light (IPL)
Light Output Power	3 – 5 J/cm²
Pulse duration:	500 – 800 µsec
Wavelength:	475-1200nm
Galvanic current pulse parameters (R Load: 500 Ω & 1k Ω.)
Maximal output current	420 μA
Maximal output voltage	210 mv & 840 mv

Intended Use/Indication for Use

The Silk'n Infinity electric output is indicated for facial stimulation for over-the-counter aesthetic use.

Performance Standards

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

. IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

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IEC 60601-1-2 (2014): Medical Electrical Equipment-Part 1: General requirements . for safety and Part 1-2 Collateral standard: Electromagnetic Compatibility-Requirements and tests
IEC 60601-2-57 (2011), Medical Electrical Equipment Part 2-57: Particular . Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.
IEC 60601-1-11:2010, Medical electrical equipment Part 1-11: Requirements for the . medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-2-10:2012, Medical Electrical Equipment Part 2-10: Particular . Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators

Non-Clinical (Bench) Performance Data

The Silk'n Infinity device, IPL optical output performance specifications are based on the same performance specifications as those of the main predicate, the Silk'n Glide which were already evaluated and well established in K131870 & K141242.

Two additional bench tests were performed utilizing the Silk'n Infinity device; the first was evaluating the output performance specifications of the added microcurrent technology. The test results demonstrated that the output parameters complied with the device design requirements and were in line with the reference predicate output specifications.

The second bench test was evaluating the device safety in simulated home use settings, utilizing the device on eight human volunteers while covering five different body areas. The test results showed that the device was safe for use as intended.

Furthermore, the Silk'n Infinity device underwent software validation testing as well as was tested and found to comply with the Electrical and mechanical safety standard

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(IEC 60601-1), the electromagnetic compatibility standard (IEC 60601-1-2), the nonlaser light source equipment standard (IEC 60601-2-57), requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11) and particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10).

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

Not Applicable

Substantial Equivalence

The Silk'n Infinity device is basically a modified and upgraded version of the main predicate Silk'n Glide device (510(k) K141242). Both devices utilize optical energy with the same pulse duration, wavelength and light output power. They are both powered on Continuous Operation. The Silk'n Infinity device has similar design, user interface and hardware components as the predicate Silk'n Glide device, with one major modification. The main reason for the submission of this 510(k) application is the addition of the galvanic microcurrents treatment step prior to the existing optical hair removal treatment step in order to add additional feature of skin stimulation to the current indication of hair reduction, while maintaining its safety and effectiveness.

The specifications of the microcurrent technology that is included in the Silk'n Infinity device are identical or in range to that of the Facial Spa device (510(k) K122711), the reference predicate device, a home use non-invasive device intended for facial skin stimulation. Microcurrent technology is a widely used technique in the home use cosmetic applications for skin stimulation. It produces an electrical current that stimulates the skin and increase local blood circulation.

The safety features and compliance with safety standards of the Silk'n Infinity device are similar to the safety features and compliance with safety standards of the predicate devices. All patient contacting materials were tested for biocompatibility and found to

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comply with the ISO 10993-1 standard (see detailed biocompatibility testing in Section 15). Furthermore, the design and development phases of the Silk'n Infinity device were composed of a set of performance tests, including software validation testing (provided in Section 16), electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, non-laser light source equipment testing according to IEC 60601-2-57 standard, medical electrical equipment testing in home use environment according to IEC 60601-1-11 standard and particular requirements for the basic safety and essential performance of nerve and muscle stimulators according to IEC 60601-2-10 standard (provided in Section 17) & performance bench tests (provided in Section 18). These performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the Silk'n Infinity device is substantially equivalent to the main predicate Silk'n Glide device (cleared under 510(k) K141242) and to the reference predicate Facial Spa device (cleared under 510(k) K122711 and therefore, may be legally marketed in the USA.

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.