The Trios™ system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris.

Device Description

The use of Trios 1 in aesthetic applications is based on the principle of Selective Photothermolysis. According to this principle, pulsed light parameters (wavelength, pulse duration and energy fluence) are chosen to selectively target light sensitive cells while minimizing damage to surrounding tissues. Trios The consists of the following major components: Main Console, Operator Control Panel, Three Hand Pieces. The main console contains the high voltage electronics, the control panel, monitoring modules and the cooling system. The hand pieces house the mechanism which generates the light pulse. The hand piece is connected to the system console by an umbilicus cord containing electrical wiring. Light from a Xenon flash lamp, located in the hand piece, is directed through a long-pass optical filter and focused into a transparent light guide that is placed in contact with the skin.

AI/ML Overview

This 510(k) summary for the Viora Trios™ System does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is available:

What the document does provide:

Device Name: Trios™ System
Company: Viora Ltd.
Indications for Use: Long term stable, or permanent, hair reduction; treatment of benign cutaneous vascular lesions; treatment of benign pigmented lesions; and treatment of mild to moderate inflammatory Acne Vulgaris.
Predicate Devices: Radiancy Mistral Device (K072331), IFL Professional System (K050165), McCue Energist Ultra VPL Intense Pulse Light System (K060234), and Lumenis Family of IPL Systems (K030527).
Statement of Substantial Equivalence: The document states that the Trios™ System "has the same intended use and the same performance characteristics as the following predicate devices," and therefore "is substantially equivalent to those devices."

What the document does NOT provide (and is required by your request):

A table of acceptance criteria and the reported device performance: This document is a summary and asserts substantial equivalence based on predicates. It does not present specific performance metrics or acceptance criteria for the Trios™ system itself in a clinical or performance study.
Sample size used for the test set and the data provenance: No performance study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance study is detailed.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. The device is a direct treatment device, not an AI diagnostic/interpretative tool that would typically involve MRMC studies in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI diagnostic algorithm.
The type of ground truth used: Not specified, as no study is detailed.
The sample size for the training set: Not applicable; this device is a physical IPL system, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Explanation:

This 510(k) submission establishes substantial equivalence primarily by demonstrating that the Trios™ System has the same intended use and similar performance characteristics to already cleared devices. For many energy-based aesthetic devices, detailed clinical studies with specific performance metrics and acceptance criteria comparable to what you'd expect for an AI diagnostic device are often not included in the 510(k) summary itself. Instead, the submission relies on the established safety and effectiveness of the predicate devices.

To find the kind of information you are looking for (e.g., specific clinical study results, performance metrics, and acceptance criteria), one would typically need to:

Look for a full 510(k) submission (which is usually much more extensive than the public summary).
Search for published clinical trials or peer-reviewed literature specifically on the Viora Trios™ System.
Review the labeling or user manual for performance claims, which would be substantiated by internal studies, though these might not be explicitly detailed in the public 510(k) summary.

In summary, based only on the provided text, the criteria you've asked for cannot be extracted because the document focuses on substantial equivalence to predicate devices rather than detailing the direct performance criteria and results of a specific clinical study for the Trios™ system.

Summary

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090399

Image /page/0/Picture/1 description: The image shows the word "VIORA" in a bold, sans-serif font. Above the word is a stylized graphic, resembling an infinity symbol with a curved line extending upwards from the left side. The text and graphic are black against a white background.

JUN 1 0 2009

510(k) Summary:

Trios™ System

Company Name: Viora Ltd.

Contact Person:

Danny Erez CEO

Telephone: +972-3-5622248 Fax: +972-3-5622247 E-mail: omri@vioramed.com

Authorized US Agent:

Josef Luzon - CEO Viora Inc. 30 Montgomery Street, Suite 660 Jersey City, NJ 07302

Telephone: (201) 332-4100 Fax: (201) 332-4200 E-mail: josef@vioramed.com

Date prepared: February 12, 2009

Trade Name:
TriosTM System

Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Common/usual name: Trios IPL System

Product Code: - ONF

Regulation No.: 878.4810

Class: II

Panel identification: General and Plastic Surgery Panel.

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090399
page 2 of 3

DR /

Predicate Device:

Radiancy Mistral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331;

IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 510(k) # K060234 and

Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527

Description of the device:

Trios The consists of the following major components:

. Main Console
Operator Control Panel .
. Three Hand Pieces

The main console contains the high voltage electronics, the control panel, monitoring modules and the cooling system.

The hand pieces house the mechanism which generates the light pulse. The hand piece is connected to the system console by an umbilicus cord containing electrical wiring. Light from a Xenon flash lamp, located in the hand piece, is directed through a long-pass optical filter and focused into a transparent light guide that is placed in contact with the skin.

Indications for Use:

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090399
Page 30f3

VIORA

Substantial Equivalence:

The Trios™ System has the same intended use and the same performance characteristics as the following predicate devices: Radiancy Mistral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331; IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 510(k) # K060234 and Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527. The Trios™ System is therefore substantially equivalent to those devices.

Conclusion -

The evaluation of the Trios™ System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2009

VIORA Limited % Viora Incorporated Mr. Josef Luzon Chief Executive Officer 30 Montgomery Street, Suite 660 Jersey City, New Jersey 07302

Re: K090399

Trade/Device Name: Trois™ System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology

Regulatory Class: II Product Code: ONF Dated: May 31, 2009 Received: June 3, 2009

Dear Mr. Luzon:

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 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

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Page 2-Mr. Josef Luzon

and listing (21 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N J. Me erson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

ko 9 0399

Device Name:

Trios™ System

Indications for Use:

Prescription Use X OR (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AeilkR. Ogle
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090399

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.