AC APPLICATOR, AURORA AC by SYNERON MEDICAL LTD.

The AC applicator is a device that is used for the treatment of moderate inflammatory acne vulgaries. The AC applicator treatment is based on the principle of selective (electromagnetic) thermolysis combined with photochemical reaction of the acne bacteria. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage acne bacteria and the sebaceous glands without damaging the surrounding tissues.

AI/ML Overview

The provided text is a 510(k) summary for the Syneron Medical Ltd. AC applicator, which is a device intended for the treatment of moderate inflammatory acne vulgaris. This document focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for new technologies.

As such, the information required to populate the requested table and answer the study-related questions is not present in the provided text. The document primarily identifies the device, its intended use, predicate devices, and asserts substantial equivalence based on overall performance characteristics without detailing how that performance was measured or what specific criteria it met.

Here's a breakdown of what can be inferred from the document and what cannot be provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the provided document. The document states "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit." However, no specific performance metrics or acceptance thresholds are presented.	Not specified in the provided document. The document does not provide quantitative results from a study demonstrating the device's performance against any set criteria. It only states that no significant differences exist compared to predicate devices, implying similar performance without quantifying it.

Missing Information for a Performance Study:

Since this is a 510(k) summary focused on substantial equivalence, it does not typically include the detailed clinical study information that would answer questions 2 through 9.

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

Not provided. No details on a clinical test set are present.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not provided. No ground truth establishment is described for a test set.

4. Adjudication Method for the Test Set:

Not provided. No adjudication method is mentioned as there is no described test set evaluation.

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

No. The document does not describe an MRMC study.

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

Not applicable. This is a physical medical device (AC applicator), not an AI algorithm, so the concept of "standalone algorithm performance" does not apply in this context.

7. The Type of Ground Truth Used:

Not provided. No ground truth is described.

8. The Sample Size for the Training Set:

Not provided. This document does not describe a training set.

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

Not provided. No training set ground truth establishment is described.

Summary:

The provided document (K032514) is a 510(k) summary, which is a premarket submission to FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. The core purpose of this type of submission is not to prove the device meets specific performance criteria through a detailed clinical study with acceptance thresholds, but rather to show it's as safe and effective as existing devices. Therefore, the detailed information about acceptance criteria, study methodologies, and performance results requested are generally not found in a 510(k) summary.

Summary

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11032514

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. AC applicator

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

Syneron Medical Ltd., Sultam Industrial park, P.O.B. 550, Submitter: Yokneam Elite 20692, Israel. Tel. +972-4-909-7424 ext. 7604, Fax +972-4-909-7417
Name of the Device: AC applicator
AC applicator is substantially equivalent to a combination of Predicate Devices: the following devices: Aurora SR, manufactured by Syneron Medical Ltd. and subject of K031993. ClearLight phototherapy device, manufactured by CureLight and subject of K013623. Omnilux Blue, manufactured by Photo Therapeutics limited and subject of K030883. Smoothbeam laser system, manufactured by Candela Corp. and subject of K014128.
Device Description: The AC applicator is a device that is used for the treatment of moderate inflammatory acne vulgaries. The AC applicator treatment is based on the principle of selective (electromagnetic) thermolysis combined with photochemical reaction of the acne bacteria. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage acne bacteria and the sebaceous glands without damaging the surrounding tissues.

The AC applicator is intended for the treatment of moderate inflammatory acne vulgaries.

Based upon an analysis of the overall performance characteristic for the device, Syncron Medical Ltd. believes that no significant differences exit. Therefore the AC applicator should raise no new issues of safety or effectiveness.

August 12, 2003

Amir Walden

Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.

Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2004

Dr. Amir Waldman Director Regulatory Affairs Syneron Medical Ltd. Sultan Industrial Park P.O.B. 550 Yokneam Elite 20692, Israel

Re: K032514

Trade/Device Name: AC Applicator, Aurora AC Regulation Number: 21 CFR 878.4810, 21 CFR 878.4400 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology, Electrosurgical Cutting and Coagulation Device and Accessories

Regulatory Class: II Product Codes: GEX, GEI Dated: November 13, 2003 Received: November 17, 2003

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 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.

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Page 2 - Dr. Amir Waldman

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Miriam C. Provost

fo' Celia M. Witten, Ph.D., M.D. 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)_ K 032514

Device Name AC applicator.

Indications For Use:

The AC applicator indicated for the treatment of moderate inflammatory acne vulgaries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109)

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Miriam C. Provost

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.