Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Device Description

The Ultimate Contour is a body sculpting device that combines the technologies of radio-frequency in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece the appropriate energy intensity based on the settings selected. Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos. The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Ultimate Contour" and "Ultimate Contour Mini." It does not describe an AI/algorithm-based device, but rather a physical device that uses radio frequency for therapeutic purposes.

Therefore, many of the requested criteria for AI/algorithm acceptance and study details (such as sample size for test/training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's performance testing and general acceptance criteria as described in the document.

Here's the closest interpretation of the requested information based on the provided document, with notes indicating why certain points are not applicable:

Device Name: Ultimate Contour, Ultimate Contour Mini
Regulation Number: 21 CFR 878.4400 (Electrosurgical Cutting and Coagulation Device and Accessories)
Regulatory Class: Class II
Product Code: PBX
Indications for Use: Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Acceptance Criteria and Reported Device Performance

The document describes performance testing rather than explicitly stating acceptance criteria in a quantitative sense for each indication. However, it implicitly aims to demonstrate the device's ability to achieve the stated therapeutic effects or safety parameters.

Table of Acceptance Criteria (Inferred from Performance Testing) and Reported Device Performance:

Acceptance Criterion (Inferred)	Reported Device Performance (as described in the document)
Electrical Safety and Electromagnetic Compatibility: Compliance with relevant standards.	Demonstrated to comply with the performance requirements of IEC 60601-1: 3rd Edition, IEC 60601-1-2: 3rd Edition, and IEC 60601-1-6.
Performance Bench Testing: Meets essential performance requirements, specifically RF power generation and hardware/software function.	Demonstrates that the Ultimate Contour meets the essential performance requirements established for the device, including measurements of the radio frequency power generated, and essential aspects of hardware and software performance. All essential functions are demonstrated to work according to design specifications.
Biocompatibility: Materials are safe for patient contact.	Materials used in the patient-contacting portions are equivalent to legally marketed reference devices that incorporate patient-contacting articles used for contacting similar tissues.
Clinical Performance Testing (for heating skin tissues): Capable of heating tissue to 40-45°C within 10 minutes without exceeding 45°C.	Clinical performance testing was conducted and demonstrates that the device is capable of heating skin tissues of the abdomen, thigh, arm, neck, and face to 40-45°C within 10 minutes without exceeding 45°C, in support of the claimed indication.

Study Details

Many of these points are not applicable as this is not an AI/algorithm-based device being submitted for a clinical study to prove algorithmic accuracy. It's a physical device seeking substantial equivalence based on technical characteristics and limited clinical performance testing.

Sample size used for the test set and the data provenance:
- For Clinical Performance Testing (heating skin tissues): "a single-site study on 5 human patients with varying skin pigmentation".
- Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection from human subjects. The document is part of a US FDA submission, so the study would likely have been conducted, or data collected, in North America, but this is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This document describes a physical medical device. The "ground truth" for the clinical performance testing was the direct measurement of skin tissue temperature, not an expert assessment of an image or diagnostic output for an algorithm. There is no indication of experts establishing a "ground truth" label in the sense of an AI model's training or testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept applies to human reader studies often used to establish ground truth for AI algorithms or assess reader performance. The testing for this device involved direct physical measurements (temperature) and engineering verification (electrical safety, RF power), not qualitative assessments requiring adjudication.
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:
- N/A. This device does not involve AI or human-in-the-loop assistance for interpretation. It's a direct therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm/AI device. The "standalone" performance here would refer to the device itself operating as intended. Bench testing and the limited clinical performance testing (heating tissues to a specific temperature range) serve this purpose for the physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the Clinical Performance Testing: The ground truth was direct physiological measurement (skin tissue temperature, measured to be within 40-45°C). It was not based on expert consensus, pathology, or broader outcomes data for the described study.
- For other tests (electrical safety, RF power), the "truth" was compliance with engineering standards and design specifications.
The sample size for the training set:
- N/A. This refers to AI/machine learning models. There is no mention of an AI training set for this device.
How the ground truth for the training set was established:
- N/A. As there is no AI training set, this question is not applicable.

Summary

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October 20, 2017

CAO Group, Inc. Mr. Robert Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, Utah 84084

Re: K171052

Trade/Device Name: Ultimate Contour, Ultimate Contour Mini Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: September 14, 2017 Received: September 18, 2017

Dear Mr. Larsen:

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, 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 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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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 (DICE) 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 (DICE) 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, Jennifer R. Stevenson -S3

For 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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Indications for Use

510(k) Number (if known) K171052

Device Name Ultimate Contour Ultimate Contour Mini

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Applicant Information:

Company Name:	CAO Group, Inc.
Company Address:	4628 West Skyhawk Drive
	West Jordan, Utah 84084 U.S.A.
Company Phone:	1-801-256-9282
Company Fax:	1-801-256-9287

Robert K. Larsen Contact Person: Preparation Date: October 17, 2017

Device Name:

Trade Name:	Ultimate Contour
Common Name:	Massager, vacuum, radio frequency induced heat
Product Code:	PBX
Regulation:	878.4400
Product Classification:	Class II

Legally Marketed Predicate Devices for Substantial Equivalence:

Venus Legacy, manufactured by Venus Concept, Ltd. (K143554)

Legally Marketed Reference Devices:

Axiem Touch-N-Go Registration Pointer, manufactured by Medtronic Navigation, Inc. (K141833)

Bi-Funnel Gastrostomy Feeding Tube with ENFit Connector, manufactured by Xeridiem Medical Devices (K171347)

Description of Submitted Device:

Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.

The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the

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exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.

Indications for Use of the Submitted Device:

The submitted device is indicated for -

Summary of Technological Characteristics and Substantial Equivalence:
	CAO Group, Inc.	Venus Concept, Ltd.
	Ultimate Contour	Venus Legacy
Radio Frequency	1MHz	1MHz
Radio Power	80W	150W
(Max.)
Electrical Power	100-240VAC, 50-60Hz, 207VA	100/110/240VAC, 50/60Hz, 670VA
Input (System)
Cooling Method	Heatsink/Air Convection	Not available
(Handpiece)
Cooling Method	Heatsink / Fan air cooled	Not available
(Unit)
Application Time	10-40 minutes	30 minutes
Dimensions	(Model 005-00035): 19" x 19" x 50"	15.75″ x 15.75″ x 40″
	(Model 005-00036): 13.75" x 14.5" x 14"
Weight	(Model 005-00035): 45.0 lbs.	88.0 lbs.
	(Model 005-00036): 5.0 lbs
User Interface	Interactive color LCD touchscreen	Interactive color LCD touchscreen
Patient-	Stainless Steel	Stainless Steel
Contacting	Nylon Plastic	ABS Plastic
Materials
Sterilization of	None Specified	None Specified
Patient-
Contacting
Materials
Environment of	Controlled medical office or practice	Controlled medical office or practice
Use
510(k) Number	K171052	K143554
Indications for	Application of non-thermal radio frequency	The Venus Legacy CX device is intended for the
Use	for relief of minor muscle aches and pains,	treatment of the following medical conditions;
	relief of muscle spasm, temporary	using LB2 and LF2 applicators for the delivery
	improvement of local blood circulation, and	of non-thermal RF combined with massage and
	temporary reduction in the appearance of	magnetic field pulses:
	cellulite.	●Relief of minor muscle aches and pain,
		relief of muscle spasm
		Temporary improvement of local blood●

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CAO Group, Inc.Ultimate Contour	Venus Concept, Ltd.Venus Legacy
	circulation• Temporary reduction in the appearance ofcellulite

Rationale for Substantial Equivalence:

The submitted device shares the same indications for use as the predicates. The submitted device utilizes the same energy type and means of energy application as the predicate device is used by the same type of operator as the predicate devices. The submitted device provides for similar user interface and control mechanisms as the predicate devices.

Performance Data:

ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY

The Ultimate Contour is demonstrated to comply with the performance requirements of IEC 60601-1: 3ª Edition, IEC 60601-1-2: 3" Edition, and IEC 60601-1-6.

PERFORMANCE BENCH TESTING

Bench testing per internal verification testing demonstrates that the Ultimate Contour meets the essential performance requirements established for the device, including measurements of the radio frequency power generated, and essential aspects of hardware and software performance. The software of this device is stated as a Major level of concern since failure of the software could present significant risk to the patient. All essential functions are demonstrated to work according to design specifications.

BIOCOMPATIBILITY

Materials used in the patient-contacting portions of this device are equivalent to legally marketed reference devices listed above that incorporate patient-contacting articles used for contacting similar tissues.

CLINICAL PERFORMANCE TESTING

Clinical performance testing for radio frequency performance was conducted via a single-site study on 5 human patients with varying skin pigmentation and demonstrates that the device is capable of heating skin tissues of the abdomen, thigh, arm, neck, and face to 40-45°C within 10 minutes without exceeding 45°C, in support of the claimed indication for this device.

Conclusion:

The Ultimate Contour is substantially equivalent to the listed predicate. This device shares identical intended use, identical operating principles, similar design features, and similar functional and performance characteristics.

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.