The Venus Freeze (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

Device Description

The Venus Freeze (MP)2 is a noninvasive, non-ablative device consisting of:

Main Unit (console)
Touch Screen user interface
RF Power module
Controller unit
Two treatment applicators:
(1) Octipolar™ applicator - for large area treatments, composed of 8 RF electrodes, 8 electrode coils assembled over electrodes and 1 central coil (the RF is emitted through the electrodes. The PMF is generated by the coils).
(2) Diamondpolar™ applicator - for small area treatments, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).
Touch screen user interface provides:
Applicator selection (Octipolar™ / Diamondpolar™)
RF Power Output and Treatment Time parameter adjustments to fit individual patient's skin condition and anatomical site treated.
Current treatment parameters display.
The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

AI/ML Overview

The provided text describes the Venus Freeze (MP)2 System, a non-invasive device for treating moderate to severe facial wrinkles and rhytides. While it mentions regulatory compliance and a clinical study, it does not provide detailed acceptance criteria or the comprehensive study breakdown as requested.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Compliance with ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment.	No unexpected adverse side effects were detected or reported in the clinical study.
Effectiveness (Implicit): Non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.	"The data reported in this study clearly indicate that the Venus Freeze (MP) System... combines the well established safe and effective Freeze RF technology with the PMF technology." (No specific quantitative performance metrics are provided to define "effective").
Regulatory Compliance: European Medical Directive 93/42/EEC (Annex II), EN 60601-1, IEC 60601-1-2.	Device complies with these standards.

Missing Information for this table:

Specific, quantitative acceptance criteria for effectiveness. For example, a percentage reduction in wrinkle severity as measured by a specific scale, or a certain percentage of patients achieving a predefined improvement. The document only states "clearly indicate" effectiveness without defining measurable criteria.

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

Sample size for test set: Not explicitly stated. The document refers to "Patients were treated with the Venus Freeze (MP)2 System for face wrinkle reduction" but does not give a number for the study population.
Data provenance: Not explicitly stated. It's a clinical study conducted to support a 510(k) submission, suggesting it's prospective, but the geographical origin of the data (country) is not mentioned.

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. The document makes no mention of expert evaluation, subjective grading, or the qualifications of any such experts.

4. Adjudication method for the test set

This information is not provided. Given the lack of expert involvement details, adjudication methods are not discussed.

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, an MRMC comparative effectiveness study was not done. This device is an aesthetic medical device, not an AI-powered diagnostic tool, so such a study would not be applicable. The text describes a system that uses RF and PMF technology directly on patients, not an AI that assists human readers.

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

Not applicable. This is a medical device for direct patient treatment, not an algorithm, so "standalone performance" in the context of an algorithm is irrelevant.

7. The type of ground truth used

The "ground truth" for the device's effectiveness appears to be based on clinical observation of wrinkle reduction and the absence of unexpected adverse side effects. However, the specific method of measuring wrinkle reduction (e.g., a standardized scale, physician assessment, patient satisfaction) is not detailed.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that undergoes training. It's a hardware device with specific energy delivery mechanisms.

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

Not applicable. See point 8.

In summary:

The provided 510(k) summary focuses on the device description, intended use, predicate devices, and general safety and regulatory compliance. While it mentions a clinical study to demonstrate effectiveness ("face wrinkle reduction") and safety, it lacks the granular detail requested for acceptance criteria, study design (especially sample sizes and expert involvement for ground truth), and performance metrics typically found in efficacy studies for AI or diagnostic devices. The closest the document comes to performance is the statement that "No unexpected adverse side effects were detected or reported" and that the data "clearly indicate" effectiveness, but without quantitative measures or specific acceptance thresholds for that effectiveness.

Summary

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VENUSCONCEPT

Page 1 of 3

510(K) SUMMARY

MAR - 2 2012

Venus Freeze (MP)2 System 510(k) Number K111670

Applicant's Name: Venus Concept Ltd. 62 HaHermesh Street Karmiel, 21652, Israel Tel: (972)3-644-6656 Fax: (972)3-644-6319

Contact Person: Yoram Levy, Osite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
Venus Freeze (MP)2 Trade Name:

Summary May 12, 2011 Preparation Date:

Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery

Device Description:

The Venus Freeze (MP)2 is a noninvasive, non-ablative device consisting of:

Main Unit (console) 1
-Touch Screen user interface
RF Power module -
Controller unit ﮯ
Two treatment applicators:

(1) Octipolar™ applicator - for large area treatments, composed of 8 RF electrodes, 8 electrode coils assembled over electrodes and 1 central coil (the RF is emitted through the electrodes. The PMF is generated by the coils).

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670 VENUSCONCEPT

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Page 2 of (3)

(2) Diamondpolar™ applicator - for small area treatments, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils). .

Touch screen user interface provides:

Applicator selection (Octipolar™ / Diamondpolar™) -
RF Power Output and Treatment Time parameter adjustments to fit . individual patient's skin condition and anatomical site treated.
Current treatment parameters display. -

The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

Intended Use Statement:

The Venus Freeze (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

Predicate Devices: Substantial equivalence to the following predicate device is claimed:

Device Name	510k No	Date of Clearance
Venus Freeze System	K100586	Nov 29, 2010

The Venus Freeze (MP)2 magnetic flux safety claim is based on the following devices:

Device Name	510k No	Date of Clearance
NeuroStar® TMS Therapy System	K083538	Dec 16, 2008
CIRRUS OPEN MagneticResonance Diagnostic Device	K090080	March 23, 2009
OPER Series Open TypePermanent-Magnet MRI	K092899	Nov 10, 2009

These devices are not considered predicate devices for the Venus Freeze (MP)2. They are presented as devices that apply much higher magnetic flux densities than the Venus Freeze (MP)2 onto the same parts of the body, to support the claim that there are no questions of safety with this energy in the proposed device.

Venus Freeze – 510k Notification

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KIII 670

VENUSCORCEPT

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Performance Standards

Venus Freeze (MP)2 complies with ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment.

In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:

EN 60601-1 (Medical Electrical Equipment-Part 1: General . Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).

IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: ● Standard: Electromagnetic Compatibility -Collateral Requirements and Tests)
A detailed description appears in Section 14.

Summary of Clinical performance data

Patients were treated with the Venus Freeze (MP)2 System for face wrinkle reduction.

No unexpected adverse side effects were detected or reported.

The data reported in this study clearly indicate that the Venus Freeze (MP) System that simultaneously use RF and PMF technology, combines the well established safe and effective Freeze RF technology with the PMF technology.

Venus Freeze - 510k Notification

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.

Public Health Service

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

MAR - 2 2012

Venus Concept Ltd % Osite Yoram Levy 31 Haavoda St. Binyamina, Israel 30500

Re: K111670

Trade/Device Name: Venus Freeze (MP)2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 3, 2012 Received: February 7, 2012

Dear Yoram Levy:

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

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Page 2 - Yoram Levy

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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

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

Enclosure

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VENUSCONCEPT

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K11670

Device Name:

Venus Freeze (MP)"

Indications for Use:

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

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)

(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number

Nil Re Ogde for mkm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_K111670

Venus Freeze - 510k Notification

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.