The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

Device Description

The PicoSure™ workstation is a high powered Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.

AI/ML Overview

The provided text describes the Cynosure Picosure™ Workstation and its indications for use. It includes a summary of clinical study findings related to the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria	Reported Device Performance
Correct identification of post-treatment photograph in 80% or greater of subjects.	The three blinded evaluators correctly identified the "before" and "after" images in 91% of the 38 subjects who returned for 4-month evaluation. This meets the 80% or greater criterion.
Fitzpatrick Wrinkle Severity Scale (FWSS) improvement score of "1" or greater at four months.	The mean improvement score using the Fitzpatrick Wrinkle Severity Scale at four months was 1.2. This meets the "1" or greater criterion.
No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs).	No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs) were reported in this study. The events that were logged were typical reactions to laser treatments. This criterion was met.

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

Sample Size for the Test Set:
- The study included 40 subjects.
- 38 subjects returned for the 4-month evaluation, which is the test set for the photo and FWSS evaluations.
Data Provenance: The document does not specify the country of origin. The study was conducted as a prospective clinical trial, as evidenced by "before and after" evaluations and follow-up at 4 months post-treatment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Three blinded evaluators were used.
Qualifications of Experts: The document does not specify the qualifications of these evaluators (e.g., dermatologists, plastic surgeons, years of experience).

4. Adjudication method for the test set

The document implies a consensus or independent evaluation method, as it states "three blinded evaluators, who were able to identify correctly the before and after images in 91% of the 38 subjects." It doesn't explicitly state an adjudication method like 2+1 or 3+1 for discrepancies, but given the high agreement (91%), it might not have been a significant issue or simply not detailed in this summary. It appears each evaluator made an independent judgment, and the percentage reflects the overall agreement across all three for the majority of cases.

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, an MRMC comparative effectiveness study involving AI assistance was not done. The study evaluated the effectiveness of the laser device itself, with human evaluators assessing the outcome of the treatment without AI assistance.

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. The primary focus was on the efficacy of the Picosure™ Workstation when applied to human subjects, with human evaluators determining the success of the treatment.

7. The type of ground truth used

The ground truth for the effectiveness of the treatment was established by expert assessment of photographs (for correct identification of before/after images) and the Fitzpatrick Wrinkle Severity Scale (FWSS) scores, also assessed by experts, indicating a clinical improvement. Safety ground truth was based on reported adverse events.

8. The sample size for the training set

This document describes a clinical study to demonstrate the effectiveness of the medical device as a treatment. It is not describing the development or validation of an AI algorithm, so there is no mention of a training set in the context of machine learning. The "training set" for the device's efficacy would be considered the prior research and development that led to the device's design, but this is not a data set in the AI sense.

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

As there is no AI algorithm being described, there is no training set ground truth in the context of an AI algorithm. The device's "ground truth" for its intended performance is based on the underlying scientific principles of laser-tissue interaction and prior clinical research on similar technologies, not on a labeled dataset for an algorithm.

Summary

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

May 23, 2016

Cynosure, Incorporated Mr. Kevin J. O'Connell Senior Regulatory Affairs Manager 5 Carlisle Road Westford, Massachusetts, 01886

Re: K140719

Trade/Device Name: Picosure™ Workstation 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: GEX Dated: August 27, 2014 Received: August 29, 2014

Dear Mr. O'Connell

This letter corrects our substantially equivalent letter of September 22, 2014.

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

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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 (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" (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,

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) K140719

Device Name Picosure™ Workstation

Indications for Use (Describe)

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

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

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A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

807.92(a)(1) - Submitter Information
Name	Cynosure, Inc.
Address	5 Carlisle RoadWestford, MA 01886USA
Phone number	978-367-8736
Fax number	978-256-6556
Establishment RegistrationNumber	1222993
Name of contact person	Kevin J. O'Connell
Date prepared	April 4, 2016
807.92(a)(2) - Name of device
Trade or proprietary name	PicoSure™ workstation
Common or usual name	laser
Classification name	Instrument, Surgical, Powered, laser
Classification panel	General and Plastic Surgery
Regulation	21 CFR 878-4810
Product Code(s)	GEX
807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
	PicoSure™ workstation K121346PicoSure™ workstation K133364Apogee Elite laser K034030
807.92(a)(4) - Device description
The PicoSure™ workstation is a high powered Alexandrite system thatdelivers laser energy in the 755-nm wavelength. The system consists ofa console that houses the power supply, control electronics and thelaser. Laser energy is delivered to the skin via an articulated arm. Thelaser is activated using a footswitch.
807.92(a)(5) Intended use of the device
Indications for use	The PicoSure™ workstation is indicated for tattoo and benignpigmented lesions removal. The PicoSure™ workstation with the 3mmand 6mm hand pieces and the Focus Array are indicated for thetreatment of acne scars and wrinkles in Skin Types I-IV.

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Characteristic	PicoSure™Workstation(current submission)	PicoSure™WorkstationK133364	PicoSure™WorkstationK121346	EliteK034030
Laser Type	alexandrite	alexandrite	alexandrite	alexandrite
Wavelength	755nm	755nm	755nm	755 nm
Maximum AverageFluence	6.37 J/cm²	6.37 J/cm²	6.37 J/cm²	60 J/cm²
Repetition Rate	Single pulse, or 1,2.5, 5, or 10 pulse(s)per second (Hz)	Single pulse, or 1,2.5, 5, or 10 pulse(s)per second (Hz)	Single pulse, or1,2,5, or 10 pulse(s)per second (Hz)	1 to 5 pulse(s) persecond (Hz)
Pulse Width	450ps-900ps	400ps-900ps	400ps-900ps	0.1 to 300 ms
Spot Sizes	Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8,10 mmwith FOCUS lensarray 3mm, 6 mm	Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8,10 mmwith FOCUS lensarray 3mm, 6 mm	Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8,10 mm	Fixed 3, 5, 7, 10,12.5 and 15
807.92(b)(2) CLINICAL TESTS SUBMITTED
Discussion of Clinical Study:The study was performed using 40 subjects ages 47 – 64 whose skin typesranged from I to IV. Before and after ( 4 months post treatment)photographs were evaluated by three blinded evaluators, who were able toidentify correctly the before and after images in 91% of the 38 subjects thatreturned for 4 month evaluation. The mean improvement score using theFitzpatrick Wrinkle Severity Scale at four months was 1.2 Therefore theprimary objectives of the study: correct identification of post treatmentphotograph of 80% or greater and FWSS improvement score of "1" orgreater, have been met. There were no deaths, serious adverse events(SAEs) or unanticipated adverse device effects (UADEs) reported in thisstudy. The events that were logged were typical reactions to lasertreatments

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.