The provided document outlines the substantial equivalence determination for the Tria FANp device for the treatment of periorbital wrinkles. However, it does not contain the specific acceptance criteria for device performance, nor detailed results of a study designed to explicitly meet such criteria in the format requested. The document describes a safety and effectiveness study, but its focus is on demonstrating substantial equivalence to a predicate device, rather than proving the device meets predefined, quantitative performance acceptance criteria.

Therefore, the following information cannot be fully extracted or is not present in the provided text:

A table of acceptance criteria and the reported device performance: The document does not provide a table of performance metrics with specific acceptance thresholds. It states the device was "found to be as safe and effective as the predicate non-ablative fractional device," but doesn't quantify this.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable as this is a medical device (laser), not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for the same reason as above.
The sample size for the training set: Not applicable as this is a medical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable for the same reason.

Below is an attempt to extract relevant information given the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Not explicitly stated)	Reported Device Performance	Comments
Safety	To be as safe as the predicate	Found to be as safe as the predicate non-ablative fractional device	No specific safety endpoints or thresholds are provided.
Effectiveness	To be as effective as the predicate	Found to be as effective as the predicate non-ablative fractional device	No specific effectiveness endpoints (e.g., wrinkle reduction percentage, visual scores) or thresholds are provided.

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

Sample Size: 45 subjects.
Data Provenance: The study was a "prospective, open-label safety and effectiveness study" conducted to evaluate the Tria FANp. The country of origin is not specified, but the submission is to the US FDA. Given the context of a 510(k) submission, it is likely the study was conducted in a country with established regulatory pathways for medical devices, potentially the US.

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 in the document. The document describes a study to evaluate safety and effectiveness but does not specify how "effectiveness" (e.g., wrinkle reduction) was objectively measured or by whom (e.g., blinded expert evaluators, clinical photography with grading scales).

4. Adjudication method for the test set

Not mentioned in the document.

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

Not applicable. The Tria FANp is a physical laser device for treatment, not an AI diagnostic or assistance tool.

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

Not applicable. The Tria FANp is a physical laser device for treatment, not an algorithm.

7. The type of ground truth used

The document broadly refers to "safety and effectiveness." For safety, this would likely involve adverse event reporting. For effectiveness, it would typically involve clinical assessment of wrinkle reduction, potentially via standardized photographic scales or expert grading. However, the specific method for establishing "ground truth" (e.g., expert consensus, objective measurement) is not detailed.

8. The sample size for the training set

Not applicable. The Tria FANp is a medical device, not an AI/ML algorithm.

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

Not applicable. The Tria FANp is a medical device, not an AI/ML algorithm.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

December 30, 2014

Tria Beauty Incorporated % Mr. Johnathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, North West Washington, District of Columbia 20004

Re: K141868 Trade/Device Name: Tria FANp Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG Dated: November 12, 2014 Received: November 12, 2014

Dear Mr. Kahan:

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

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

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,

David Krause -S

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

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

Indications for Use

510(k) Number (if known) K141868

Device Name Tria Fanp

Indications for Use (Describe)

The FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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

Tria Beauty's Tria FANp

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Tria Beauty, Inc. 4160 Dublin Blvd. Ste 200 Dublin, CA 94568 Phone: 925-452-2500 Facsimile: 925-452-2595 Contact Person: Tobin Island, Ph.D. Date Prepared: June 30, 2014

Name of Device and Name/Address of Sponsor

Tria FANp Tria Beauty, Inc. 4160 Dublin Blvd, Ste 200 Dublin, CA 94568

Common or Usual Name

Diode Laser

Classification Name

Laser Instrument, Surgical, Powered Regulation Number: 21 CFR§878.4810 Product Code: ONG

Predicate Devices

Tria Beauty, Inc., Tria FAN System (K130459)

Intended Use / Indications for Use

Tria FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).

Technological Characteristics

The Tria FANp is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.

Performance Data

Performance data was submitted with this 510(k) notification to support the determination of substantial equivalence for the Tria FANp relative to its predicate device.

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

Performance Testing (Non-Clinical):

Performance testing was conducted to demonstrate that the Tria FANp performs according to specifications and functions as intended.

Animal:

A GLP compliant histology study was conducted. Hairless guinea pigs were treated with the Tria FANp and tissue sampling occurred immediately, 5 days, and 14 days post-treatment. The tissue response was found to be equivalent to the predicate nonablative fractional device.

Clinical:

A 45-subject, prospective, open-label safety and effectiveness study was conducted to evaluate the Tria FANp for the treatment of periorbital wrinkles. The Tria FANp was found to be as safe and effective as the predicate non-ablative fractional device.

Substantial Equivalence

The Tria FANp has the same intended use and indication, the same principles of operation, and similar technological characteristics as its predicate device. The minor technological differences between the Tria FANp and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Tria FANp is as safe and effective as the predicate device. Thus, the Tria FANp is substantially equivalent.

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.