ULTHERA SYSTEM by ULTHERA, INC. | FDA 510(k) Summary

The Ulthera System was evaluated in an open-label clinical trial to support an expanded indication for lifting lax submental (beneath the chin) and neck tissue.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Metric	Reported Device Performance
Improvement in lift	51 out of 70 patients (72.9%) had an improvement of ≥20 mm² in lift. Among these, 84.3% were identified as showing improvement by masked evaluators.
Safety	Adverse events were mild, short-lived, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) were reported.
Patient Satisfaction (Qualitative Assessment)	Used as an evaluation method, but specific performance metrics are not detailed in the provided text.

Important Note: The provided document is a 510(k) summary, which often provides a high-level overview. A full clinical study report would contain more detailed acceptance criteria and specific statistical thresholds for primary and secondary endpoints. For example, it's not explicitly stated what percentage of patients with ≥20 mm² lift was required for acceptance; only the observed performance is given.

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

Sample Size: 70 patients.
Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "open-label clinical trial," which implies a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated. The document mentions "masked evaluators" identified improvement in 84.3% of patients with ≥20 mm² lift. The exact number of these evaluators and their qualifications (e.g., dermatologists, plastic surgeons, years of experience) are not provided in this summary.

4. Adjudication Method for the Test Set

The document mentions "masked evaluators" were used, but it does not specify an adjudication method (e.g., 2+1, 3+1, none) for disagreements among these evaluators. This detail would typically be in a full clinical study protocol.

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

No, an MRMC comparative effectiveness study that assesses human readers' improvement with AI vs. without AI assistance was not conducted. This study is evaluating the device's direct clinical effect, not an AI's impact on human interpretation.

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

Yes, in a sense, a standalone evaluation was done for the device's direct clinical effect. The "Improvement was evaluated through quantitative assessment, qualitative assessment and patient satisfaction questionnaires." This is an assessment of the device's performance in situ on patients, which is analogous to a standalone performance from the device's perspective, without requiring human interpretation of output from the device. However, it's not an AI algorithm being evaluated in isolation.

7. The Type of Ground Truth Used

The ground truth was established through a combination of quantitative assessment (≥20 mm² in lift, likely measured objectively by a physician or imaging) and qualitative assessment by "masked evaluators." This suggests a blend of objective measurement and expert visual assessment. Patient satisfaction questionnaires also contributed to the overall evaluation of improvement.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This study describes a clinical trial evaluating the therapeutic effect of the Ulthera System, not the performance of an AI algorithm that would typically require a training set. The Ulthera System is a focused ultrasound stimulator, not an AI diagnostic tool.

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

Not Applicable / Not Provided. As this is not an AI algorithm study, there is no "training set" or ground truth establishment method for a training set described.

Summary

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510(k) Summary

This 510(k) Summary for the Ulthera "System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

Applicant:	Ulthera, Inc.
Address:	2150 South Country Club Drive, Suite 21Mesa, AZ 85210
Contact Person:	Suzon Lommel, VP of Regulatory & Quality Affairs
Telephone:	480-649-4069
Fax:	480-619-4071
Submission Date:	June 7, 2012
Device Trade Name:	Ulthera® System
Common Name:	Focused Ultrasound Stimulator Use System for Aesthetic Use
Classification:	Regulatory Class II
Classification Name:	Focused Ultrasound Stimulator Use System for Aesthetic Use
Product Code:	OHV
Legally Marketed	Name: Ulthera® System
Predicates:	510(k): #K072505
Applicable Guidance:	The Class II Special Controls Guidance Document: Focused UltrasoundStimulator System for Aesthetic Use was developed in response to Ulthera'sDeNovo submission and 510(k) clearance K0272505 for the Ulthera System.

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The Ulthera System consists of the following components: Device Description: Ulthera® Control Unit . Handpiece . . Transducers The Ulthera System is indicated for use as a non-invasive dermatological Indications for Use: aesthetic treatment to: lift the eyebrow (current cleared indication) . . lift lax submental (beneath the chin) and neck tissue {requested expanded indication) To support the expanded indication, the Ulthera® System was evaluated in Performance Data: an open-label clinical trial investigating the clinical response following treatment with the Ulthera® System to achieve lifting of lax submental (beneath the chin) and neck tissue. Improvement was evaluated through quantitative assessment, qualitative assessment and patient satisfaction questionnaires. There were 51/70 patients that had an improvement of ≥20 mm² in lift, of these patients 84.3% were identified as showing improvement by masked evaluators. The adverse events resulting from treatment with the Ulthera® System during this study were mild, short-lived in duration, and resolved without incident. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the Ulthera® System. Conclusion: Based on the design, materials, principle of operation, and intended use, the Ulthera® System is substantially equivalent to the legally marketed predicate device.

Image /page/1/Picture/1 description: The image shows the word "Ulthera" in a stylized font. The letters are outlined, giving them a distinct appearance. Above the "era" portion of the word, there are three small circles arranged horizontally.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ulthera, Incorporated % Ms. Suzon Lommel Vice President of Regulatory & Quality Affairs 2150 South Country Club Drive, Suite 21 Mesa, Arizona 85210

OCT 2 2012

Re: K121700

Trade/Device Name: Ulthera® System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: August 1, 2012 Received: August 3, 2012

Dear Ms. Lommel:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Suzon Lommel

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Indications for Use Statement

K121700 510(k) Number:

Ulthera® System Device Name:

Indications for Use:

The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:

lift the eyebrow .
lift lax submental (beneath the chin) and neck tissue .

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 of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121700

Indications for Use Statement

Regulation Number and Section

§ 878.4590 Focused ultrasound stimulator system for aesthetic use.

(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.