The provided text, K082298 for the Flash N' Go device, is a 510(k) summary and associated FDA correspondence for a light-based hair removal device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results for the device itself.

Based on the provided text, I can infer the following about acceptance criteria and studies, but I cannot complete the requested tables and sections due to the limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance metrics like efficacy (e.g., percentage hair reduction) or specific safety endpoints. It broadly states:

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with 21CRF § 1040.10 & 1040.11 (Performance Standards)	"The device complies with the following U.S. Food and Drug Administration performance standards: 21CRF § 1040.10 & 1040.11." (No specific performance data related to these standards is provided beyond this statement).
Safety for intended use (hair removal)	"Clinical safety data was collected in a prospective safety study." (No specific safety outcomes or adverse event rates are reported in this summary beyond this statement).
Substantial Equivalence to Predicate Devices (ABC hair removal system, Spectra hair removal laser system, Silk'n) in terms of efficacy and safety for hair removal.	"The Flash N' Go system is substantial equivalent to its predicate devices. The data in this 510k submission demonstrate that the Flash N' Go system has identical output as the Silk'n, and shares the similar intended use as other predicate devices... Based upon an analysis of the overall performance characteristic for the device, Home Skinovations Ltd. believes that no significant differences exit. Therefore the Flash N' go should raise no new issues of safety or effectiveness." (This is a claim of equivalence, not a direct report of the device's specific efficacy or safety performance in quantitative terms).

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

Sample Size: Not specified in the provided text. The document only states "Clinical safety data was collected in a prospective safety study."
Data Provenance: The safety study was "prospective." The country of origin for the data is not explicitly stated beyond the submitter's address being in Israel.

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

Not applicable/Not specified. The document does not describe the establishment of a "ground truth" for a test set in the context of efficacy or diagnostic accuracy, as it's a hair removal device. The focus is on safety and substantial equivalence based on technical output and intended use.

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

Not applicable/Not specified. As above, this type of detail is typically for diagnostic/screening devices where interpretation of results requires expert consensus.

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. This device is a hair removal system, not a diagnostic imaging or AI-assisted interpretation tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is a physical device for hair removal, not an algorithm or AI system.

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

For the "clinical safety data," the "ground truth" would likely involve objective measures of skin reactions, adverse events, or hair reduction observed by clinicians or study personnel. However, the specific type and methodology are not detailed in this summary. The primary "ground truth" for 510(k) devices often relies on demonstrating equivalence to an already marketed and deemed safe/effective predicate device, rather than establishing a de novo "ground truth" for efficacy in clinical trials if substantial equivalence can be shown.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As above, there is no "training set" for this type of device.

In summary, the provided 510(k) summary for the Flash N' Go device primarily focuses on demonstrating substantial equivalence to predicate devices, compliance with FDA performance standards (21CRF § 1040.10 & 1040.11), and the collection of prospective clinical safety data. It does not provide detailed quantitative acceptance criteria, specific performance metrics, or the methodologies for establishing "ground truth" in the manner typically associated with AI/ML or diagnostic devices.

Summary

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Kó2298

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Home SkinovationsLtd. Flash N' Go OCT 2 3 71115

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter's information

Name:	Home Skinovations Ltd.
Address:	Apolo building, POB 533, Yokneam 20692, Israel
Contact:	Dr. Amir Waldman VP Regulatory Affairs

Device information

Trade/Proprietary name:	Flash N' Go
Common/Usual name:	Light based hair removal device
Classification name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology (21CRF §878.4810)
Product code:	GEX

Predicate devices

. ABC hair removal system, (K060839) Palomar Medical Technologies Inc.
. Spectra hair removal laser system, (K053527). SpectraGenics, Inc.
. Silk'n, (K072906). Home Skinovations Ltd.

Intended use:

The Flash N' Go is intended for removal of unwanted hair.

Device Description:

The Flash N' Go hair removal system is composed of a base unit and hand held applicator. Details are provided in the chapter 1: Device description, of this submission.

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Performance & clinical data:

The device complies with the following U.S. Food and Drug Administration performance standards: 21CRF § 1040.10 & 1040.11. Clinical safety data was collected in a prospective safety study.

Substantial Equivalence:

The Flash N' Go system is substantial equivalent to its predicate devices. The data in this 510k submission demonstrate that the Flash N' Go system has identical output as the Silk'n, and shares the similar intended use as other predicate devices. Therefore is substantial equivalent to its predicate devices. Details are provided in chapter 3: Substantial equivalent of this submission.

Based upon an analysis of the overall performance characteristic for the device, Home Skinovations Ltd. believes that no significant differences exit. Therefore the Flash N' go should raise no new issues of safety or effectiveness.

August 10, 2008

Aur Wale

Date

Dr. Amir Waldman, VP Regulatory Affairs Home Skiovations Ltd.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Home Skinovations, Ltd. % Dr. Amir Waldman VP, Regulatory Affairs Apolo Building, P.O. Box 533 Yokneam 20692 Israel

OCT 2 3 2008

Re: K082298 Trade/Device Name: Flash N' Go Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: October 2, 2008 Received: October 6, 2008

Dear Dr. Waldman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Dr. Amir Waldman

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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events, (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Wilkerson

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

Enclosure

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510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name____Flash N' Go

Indications For Use:

The Flash N' Go is an over the counter device intended for the removal of unwanted hair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over The Counter Use_X

(Optional Format 1-2-96)

Neil R.P. Ogden for mxm

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number

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.