The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation.

Device Description

The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for The Cellfina System, based on the provided text:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Endpoint)	Reported Device Performance at 5 Years
Primary Endpoint: Achievement of ≥1 point average reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and (5 years) after treatment.	The mean improvement was 1.8 points (p<0.0001) with a 97.5% upper confidence limit improvement of 1.4 points. (Met)
Secondary Efficacy Endpoint: Improvement of one grade or more in severity (none, mild, moderate, severe) in >60% of treated subjects as determined by independent physician assessment of subject photographs taken before and 5 years after treatment.	86.5% of treated subjects had ≥1-grade improvement with a 95% lower confidence limit of 74.7%. (Met)
Primary Safety Result: 100% of subjects free from Serious Adverse Events (SAE) directly attributable to the Cellfina System or procedure at 5 years.	100% of subjects were free from Serious Adverse Events (SAE) directly attributable to the Cellfina System or procedure at 5 years. (Met)
Additional Measures: Mean overall rate of correct selection (likely referring to identification of improvement by independent assessors)100% of subjects had noticeable improvement by the GAIS (Global Aesthetic Improvement Scale)35% of subjects characterized as having "Much Improved" or "Very Much Improved" by GAIS78% of subjects either "Satisfied" or "Very Satisfied"No subjects reported pain in the treatment area using an 11-point numerical rating scale at the 5-year follow-up visit.	The mean overall rate of correct selection was 92.8% with a lower 95% confidence limit of 86.3%. (Achieved/Acceptable)100% of the subjects had noticeable improvement by the GAIS. (Achieved/Acceptable)35% were characterized as having Much Improved or Very Much Improved. (Achieved/Acceptable)78% of the subjects were either Satisfied or Very Satisfied. (Achieved/Acceptable)No subjects reported pain in the treatment area using an 11-point numerical rating scale at the 5-year follow-up visit. (Achieved/Acceptable)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- 55 subjects participated in the baseline assessment and treatment.
- Follow-up progressively decreased: 3 Day (55), 14 Day (54), 1 Month (54), 3 Month (55), 6 Month (52), 1 year (50), 2 year (52), 3 year (45), 5 year (37). The primary and secondary endpoints are reported at 5 years, so the effective sample size for the long-term evaluation is 37.
Data Provenance:
- Study Design: Prospective, multi-center, non-randomized open label, safety and effectiveness study.
- Country of Origin: Not explicitly stated in the provided text, but "multi-center" implies it was conducted at several clinical sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The text refers to "independent physician assessment" for determining the Cellulite Severity Scale and classifying improvement. However, it does not specify the number of physicians or their specific qualifications (e.g., years of experience, specialty).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The text states "independent physician assessment." It does not explicitly describe an adjudication method like 2+1 or 3+1 (where multiple readers might assess independently and then a tie-breaker or consensus is used). It implies individual independent assessments were used to determine the Cellulite Severity Scale and photographic improvement.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance was not done. The Cellfina System is a physical medical device (powered surgical instrument) for treating cellulite, not an AI-powered diagnostic or assistive tool. The assessments described are of the device's clinical efficacy on patients, conducted by physicians.

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

No, a standalone (algorithm only) performance study was not done. As mentioned, The Cellfina System is a physical medical device, not an algorithm or AI. The study evaluated the device's performance in patients.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for effectiveness was primarily established by independent physician assessment of subject photographs, utilizing a Cellulite Severity Scale and classifying improvement grades.
For safety, it was based on outcomes data regarding the absence of Serious Adverse Events (SAE) attributable to the device or procedure.
Additionally, patient-reported outcomes (GAIS, satisfaction, pain levels) were also collected as secondary measures.

8. The sample size for the training set

The provided document describes a clinical study to evaluate the performance of the Cellfina System. It does not mention a "training set" in the context of an algorithm or AI model development. Therefore, no information is available on a "training set sample size" as this device is not an AI/ML product.

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

Since the device is not an AI/ML product, there is no "training set" or "ground truth for the training set" as would be applicable to such products. The clinical study described is for evaluating the device's clinical performance directly.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 9, 2019

Ulthera, Inc Lisa Pray Regulatory Affairs Manager 1840 S. Stapley Dr. Suite 200 Mesa, Arizona 85204

Re: K192185

Trade/Device Name: The Cellfina System Regulation Number: 21 CFR 878.4790 Regulation Name: Powered Surgical Instrument for Improvement in the Appearance of Cellulite Regulatory Class: Class II Product Code: OUP Dated: August 9, 2019 Received: August 12, 2019

Dear Lisa Pray:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192185

Device Name Cellfina System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

This 510(k) Summary for the Cellfina 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:	1840 South Stapley DriveSuite 200Mesa, AZ 85204
Contact Person:	Lisa Pray, Regulatory Affairs Manager
Telephone:	(480) 828-8856
Fax:	(480) 619-4071
Submission Date:	August 9, 2019
Device Trade Name:	The Cellfina System
Common Name:	Powered surgical instrument for improvement in the appearanceof cellulite.
Classification:	Regulatory Class II
Classification Name:	Powered surgical instrument for improvement in the appearanceof cellulite.
Regulation Number:	21CFR 878.4790
Product Code:	OUP
Legally Marketed Predicate:	The Cellfina System, 510(k): K161885
Applicable Guidance:	The following guidance special controls are applicable to theCellfina System:

Class II (special controls). The special controls for this device are:

(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.

(2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.

(3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.

(4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.

Image /page/3/Picture/9 description: The image shows the word "ulthera" in a stylized font. The "ul" is stacked on top of the "thera". The "ul" is in a light blue color and is made up of three vertical bars. To the right of the "ul" and above the "thera" are three orange circles in a horizontal row. To the right of the "thera" is a small trademark symbol.

{4}------------------------------------------------

K192185 The Cellfina System

(5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.

(6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.

Device Description: The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).
Indications for Use: The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation.

Substantial Equivalence Comparison:

The subject device remains unchanged from the predicate device. There has been no design, material, shelf life, cleaning and disinfection, software, or packaging updates since the predicate 510(k) submission (K161885). The subject device instructions for use have been updated to reflect compliance to IEC 60601-1-2 and to include the expanded indications for use statement.

Non-clinical Performance Data:

There have been no device changes to the subject device since the predicate device 510(k) K161885 submission. As such, all non-clinical performance data presented within the predicate device submission remains applicable to the subject device.

The only non-clinical performance data included in this submission is updated electromechanical safety testing. The predicate device of this Traditional 510(k) submission was compliant to IEC 60601-1-2:2007 3rd Edition; however, the subject device is now compliant to IEC 60601-1-2:2014 4th Edition.

Clinical Performance Data (In-Vivo):

The safety and effectiveness of the Cellfina System was evaluated in a pivotal clinical study conducted under IDE G120116. No additional treatments were performed at any followup time points. The overall study success was met (as defined within the protocol), despite the reduction in follow up participation at 5 years with a clinically significant, long term improvement in the appearance of cellulite in the treated subjects as shown within Table 05-1.

Image /page/4/Picture/12 description: The image shows the word "ulthera" in a sans-serif font. The letters are a light gray color. Above the "era" portion of the word are three orange circles. To the right of the word is a small trademark symbol.

{5}------------------------------------------------

K192185 The Cellfina System

Study Design:	Prospective, multi-center, non-randomized open label, safetyandeffectiveness study
Sample Size	55 Subjects participated in the baseline assessment and treatment
Follow up (N)	3 Day (55), 14 Day (54), 1 Month(54), 3Month (55), 6 Month (52), 1 year(50), 2 year (52), 3 year (45), 5 year (37)
InclusionCriteria	Female between the ages of 18 and 55, BMI less than 35
ExclusionCriteria	No prior drug treatment for contouring or cellulite during prior 90 days; noprior liposuction of thighs or buttocks, subject has had >10% weight lossin prior 6 months; subject has known difficulty with local anesthesia,subject is pregnant, other minor criteria
PrimaryEndpoint resultat 5 years	The primary endpoint was met: achievement of ≥1 point average reductionin the 0-5 point Cellulite Severity Scale as determined by independentphysician assessment of subject photographs taken before and (5 years)after treatment.The mean improvement was 1.8 points (p<0.0001) with a 97.5%upper confidence limit improvement of 1.4 points.
SecondaryEfficacy resultat 5 years	The powered secondary endpoint was met: improvement of one grade ormore in severity (none, mild, moderate, severe) in >60% of treated subjectsas determined by independent physician assessment of subject photographstaken before and 5 years after treatment.86.5% of treated subjects had ≥1-grade improvement with a 95%lower confidence limit of 74.7%.
Primary SafetyResult	The safety endpoint was met: 100% of subjects were free from SeriousAdverse Events (SAE) directly attributable to the Cellfina System orprocedure at 5 years
AdditionalMeasures	All additional secondary measures were also achieved or acceptable at the5 year time point:The mean overall rate of correct selection was 92.8% with a lower95% confidence limit of 86.3%.100% of the subjects had noticeable improvement by the GAIS and35% were characterized as having Much Improved or Very MuchImproved78% of the subjects were either Satisfied or Very Satisfied.No subjects reported pain in the treatment area using an 11-pointnumerical rating scale at the 5-year follow-up visit.

Table 05-1: Clinical Study Design Characteristics

Conclusion:

This Traditional 510(k) Premarket Notification is for an expanded indication for use statement. The included clinical data demonstrates that the Cellfina System is both safe and effective for the long term improvement in the appearance of cellulite in the buttocks

Image /page/5/Picture/5 description: The image shows the word "ulthera" in a stylized font. The word is in lowercase letters and is colored in a light blue-gray color. Above the "era" portion of the word are three yellow dots arranged horizontally. To the right of the dots is the trademark symbol.

{6}------------------------------------------------

K192185 The Cellfina System

and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation.

No design modifications to the Cellfina System motor module (CM1) or disposable kit (CK1) have occurred since the predicate device submission, 510(k) K161885. Updated labeling has been provided as part of this 510(k) submission for updated compliance to IEC 60601-1-2:2014.

These updated indications for use and labeling do not pose any new questions of safety, product output or efficacy. The subject device Cellfina System is as safe, as effective, and performs as well as the legally marketed predicate device (K161885), and as such, is substantially equivalent.

Image /page/6/Picture/4 description: The image shows the logo for Ulthera. The logo consists of the word "ulthera" in a sans-serif font, with the "u" and "l" in a light blue color and the rest of the word in a darker blue. To the right of the word, there are three orange circles arranged horizontally, followed by the "TM" symbol in a smaller font.

Regulation Number and Section

§ 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.

(a)
Identification. A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.
(2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.
(3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
(4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.
(5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.
(6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.