The provided document is a 510(k) summary for the Tria Sapphire device, a blue light therapy system intended for the treatment of mild to moderate inflammatory acne. It focuses on demonstrating substantial equivalence to a predicate device (Tria Beauty, Inc., ATS-1 OTC, K090312).

However, the document does not contain the detailed information required to answer your specific questions about:

Acceptance criteria and reported device performance (in terms of clinical efficacy metrics like sensitivity, specificity, accuracy, or reduction in acne lesions)
Sample sizes for a test set for clinical performance
Number/qualifications of experts for ground truth establishment
Adjudication methods
MRMC comparative effectiveness study
Standalone algorithm performance
Type of ground truth used for clinical efficacy
Sample size for training set (of an AI/ML algorithm)
Ground truth establishment for the training set

The document primarily discusses:

Non-Clinical Performance: Testing for electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation. These are about device function and safety, not clinical efficacy performance against a specific metric.
Clinical Performance (Usability Study): It mentions a "60-subject, all-comers OTC usability study."
- Purpose: To demonstrate that subjects could self-select correctly, use the device properly, and comprehend labeling.
- Outcome: "No safety issues were identified. Usability results were consistent with the predicate ATS-1 OTC device and are appropriate for over-the-counter clearance."

This "clinical" study is a usability study, not a clinical efficacy study designed to prove a certain level of performance (e.g., a specific percentage reduction in acne lesions or accuracy in diagnosis). The 510(k) pathway for this device relied on demonstrating substantial equivalence to a predicate device, and the usability study was likely used to show that despite being a new device, it could be safely and effectively used by the target OTC population, similar to the predicate.

Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions related to AI/ML device performance, clinical efficacy metrics, or ground truth establishment for such metrics.

The device outlined in this 510(k) is a light therapy system, and the "performance data" discussed is primarily related to safety, engineering specifications, and usability, rather than the kind of clinical performance data one would expect for an AI/ML-driven diagnostic device (e.g., sensitivity, specificity, AUC, etc., against a gold standard).

If this was an AI/ML device, the detailed information you're asking for would be crucial and would typically be found in a separate clinical study report or a more extensive performance section of the 510(k) submission, which is not present in this summary.

Summary

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Image /page/0/Picture/0 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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

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

June 15, 2016

Tria Beauty, Inc. % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K160821

Trade/Device Name: Tria Sapphire 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: OLP Dated: March 24, 2016 Received: March 24, 2016

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 CFR

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

Jennifer R. Stevenson -A

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)

K160821

Device Name Tria Sapphire

Indications for Use (Describe)

The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne.

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)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

Tria Beauty's Tria Sapphire

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: 925-452-2597 Contact Person: Heather Tanner Date Prepared: March 23, 2016

Name of Device and Name/Address of Sponsor

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

Common or Usual Name

Light Therapy System

Classification Name

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

Predicate Devices

Tria Beauty, Inc., ATS-1 OTC (K090312)

Intended Use / Indications for Use

The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne. It is intended for over-the-counter use.

Technological Characteristics

The Tria Sapphire is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.

Performance Data

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

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Non-Clinical:

Performance testing was conducted to demonstrate that the Tria Sapphire performs according to specifications and functions as intended. The Sapphire device was tested and found to be compliant with the following:

. Electrical safety and essential performance (IEC 60601-1)
. Electromagnetic compatibility (IEC 60601-1-2)
. Biocompatibility (ISO 10993-5 & 10993-10)
. Software verification and validation testing

Clinical:

A 60-subject, all-comers OTC usability study was conducted. Subjects demonstrated the ability to (a) make the correct self-selection (mild to moderate inflammatory acne), (b) use the device properly and (c) comprehend key directions and warnings according to the Sapphire labeling. No safety issues were identified. Usability results were consistent with the predicate ATS-1 OTC device and are appropriate for over-the-counter clearance.

Substantial Equivalence

The Tria Sapphire is substantially equivalent to the legally marketed ATS-1 OTC blue light device (K090312). It has the same general intended use and indication for use, the same principles of operation and treatment method, and substantially similar technological characteristics as the predicate. The kev technical parameters effecting safety and efficacy are identical to the predicate. The performance and consumer usability data demonstrates that any technological differences or changes in labeling do not raise new questions of safety or efficacy or alter the device's intended therapeutic effect in comparison to the predicate. Therefore, Tria Sapphire 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.