The Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

Device Description

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver thermal energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

AI/ML Overview

The provided text is a 510(k) Summary for the Sciton JOULE ProFractional System. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain acceptance criteria or details of a study proving the device meets specific performance criteria in the way a clinical trial report would.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics and indications for use of the JOULE ProFractional System to those of several predicate devices already on the market.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on your request and the limitations of the provided document:

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

This information is not available in the provided 510(k) summary. The document focuses on demonstrating "substantial equivalence" to predicate devices, not on meeting specific, quantitative acceptance criteria for performance as would be seen in a clinical study report. The table presents a comparison of technical specifications between the proposed device and predicate devices.

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

This information is not available in the provided 510(k) summary. The document does not describe a clinical test set or study data in this manner.

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)

This information is not available in the provided 510(k) summary. The document does not describe a process for establishing ground truth using experts.

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

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary. This device is a laser surgical instrument, and the document does not mention AI assistance or MRMC studies.

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

This information is not available in the provided 510(k) summary. This is a medical device, not an AI algorithm, and thus standalone performance for an algorithm is not applicable.

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

This information is not available in the provided 510(k) summary.

8. The sample size for the training set

This information is not available in the provided 510(k) summary as it is not an AI/algorithm-based device and does not refer to a "training set."

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

This information is not available in the provided 510(k) summary for the reasons mentioned above.

Summary of what the document DOES provide regarding comparison:

The document relies on demonstrating "substantial equivalence" to predicate devices (K101916, K081352, K100270, K110907, K142376) rather than defining and meeting specific, quantitative acceptance criteria via a new study.

The comparison table on page 4 (labeled "5") shows how the JOULE 2940 Fractional Handpiece (This Application) aligns with or is comparable to predicate devices across various technical specifications:

Indications for Use: "Yes" - indicates substantial equivalence to all listed predicates.
Ref. 510(k): K173285 for "This Application."
Energy Source: 2940 nm Er:YAG for all, "Yes" for substantial equivalence.
Spot Size: Range from 1.3x1.3mm to 20x20mm for the new device, comparable to predicates. "Yes" for substantial equivalence.
Wavelength: 2940 nm for all, "Yes" for substantial equivalence.
Maximum Repetition Rate: Up to 3 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
Pulse Duration: 0.5 to 1.5 msec for the new device, comparable to predicates. "Yes" for substantial equivalence.
Energy: Up to 70 mJ/microbeam for the new device, comparable to predicates. "Yes" for substantial equivalence.
Utilities: 230 VAC/25A, 50/60 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
Aiming Beam: Red/Green for new device and some predicates. "Yes" for substantial equivalence.
Delivery System: Articulated Arm for the new device, comparable to predicates. "Yes" for substantial equivalence.
Cooling System: Water to Air for all, "Yes" for substantial equivalence.
Control System: Microprocessor for all, "Yes" for substantial equivalence.
Energy Monitor: "Display Indicates Energy Delivered to Tissue" for all, "Yes" for substantial equivalence.
Safety: Safety Eyewear and Remote Interlock Connector for the new device and some predicates. "Yes" for substantial equivalence.
Console Dimensions: 14" x 21" x 41" high for the new device, comparable to some predicates. "Yes" for substantial equivalence.
Weight: 200 lbs for the new device, comparable to some predicates. "==" (presumably "Yes") for substantial equivalence.

The study that proves device meets acceptance criteria, in this context of a 510(k), is the comparison to legally marketed predicate devices, demonstrating that its technological characteristics and intended use are sufficiently similar. The "proof" is the argument of substantial equivalence, not data from a new clinical study with specific acceptance criteria.

Summary

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January 29, 2018

Sciton, Inc Mr.Jay Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303

Re: K173285

Trade/Device Name: Joule System 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: December 29, 2017 Received: January 4, 2018

Dear Mr. Patel:

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, 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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -ਟਤ

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) K173285

Device Name JOULE ProFractional 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)

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Attachment IV

510(k) Summary

Submitter:	Sciton, Inc.
Address:	925 Commercial Street, Palo Alto, CA 94303
Phone:	(650) 493-9155
Fax :	(650) 493-9146
Contact Person:	Jay M. Patel, VP of Regulatory Affairs
Date Prepared:	January 9, 2018
Device Trade Name:	JOULE ProFractional System
Common Name:	Laser Powered Surgical Device (and Accessories)
Classification Name:	Laser Surgical Instrument, 21 CFR 878.4810.
Product Code:	GEX
Legally MarketedPredicate Device:	K101916: Joule Multi-Platform SystemK081352: Profile Multi-Platform SystemK100270: Artisan Aesthetic SystemK110907: Palomar Icon Aesthetic SystemK142376: Palomar Icon Aesthetic System
Description ofJOULE ProFractionalSystem:	The JOULE ProFractional System consists of a console and laser deliveraccessories. It uses focusing optics to deliver thermal energy to the treatment site.The control console houses the power supply, cooling system, articulated armdelivery system and/or fiber optic arm delivery system with a handpiece. Theuser activates laser emission by means of a footswitch.
Intended Use:	The Joule 2940 nm ProFractional System with its accessories is intended for usein dermatological procedures requiring coagulation, resurfacing, and ablation ofsoft tissue. Procedures include skin resurfacing and treatment of wrinkles,rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, andvascular dyschromia.
TechnologicalCharacteristics:	The JOULE 2940 nm ProFractional System shares the same indications for use,and as noted below, shares similar design features (including wavelength, lasermedium and delivery systems, power supply, cooling and control system), functionalfeatures (including power output, repetition rate, energy, spot size and fluence), andis therefore substantially equivalent to the above legally marketed predicate devices.

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2940 nm Laser System
Specification	Predicate Devices				This Application	SubstantiallyEquivalent
	JOULE Multi-PlatformSystem	ProfileProFractional	PalomarLUX2940FractionalHandpiece	Cynosure	Joule 2940FractionalHandpiece
Indications forUse	The JOULE2940 nm Multi-Platform SystemwithProFractionalhandpiece anddelivery systemis intended foruse indermatologicalproceduresrequiring skinresurfacing,ablation andcoagulation ofsoft tissue.	Coagulation andresurfacing ofsoft tissue.	Coagulation,resurfacing andablation of softtissue, treatmentof wrinkles.pigmented lesionsand vasculardyschromia.	Coagulation,resurfacing, andablation of soft tissue.Procedures includeskin resurfacing andtreatment of wrinkles,rhytides, furrows, finelines, texturalirregularities,pigmented lesions,and vasculardyschromia	Coagulation,resurfacing andablation of soft tissue.Procedures includeskin resurfacing andtreatment of wrinkles,rhytides, furrows, finelines, texturalirreqularities, benignpigmented lesions,and vasculardyschromia	Yes
Ref. 510(k)	K101916	K081352	K100270, K110907	K142376	K173285	--
Energy Source	2940 nm Er:YAG	2940 nm Er:YAG	2940 nm Er:YAG	2940 nm Er:YAG	2940 nm Er:YAG	Yes
Spot Size	1.3x1.3mm to20x20mm	Up to 20 x 20mm	Up to 10 x 10 mm	Up to 10 x 10 mm	1.3x1.3mm to20x20mm	Yes
Wavelength	2940 nm	2940 nm	2940 nm	2940 nm	2940 nm	Yes
MaximumRepetition Rate	Up to 3 Hz	Up to 2 Hz	Up to 3 Hz	--	Up to 3 Hz	Yes
Pulse Duration	0.5 to 1.5 msec	0.5 to 1.5 msec	Up to 5 msec	Up to 5 ms	0.5 to 1.5 msec	Yes
Energy	Up to 70mJ/microbeam	Up to 70mJ/microbeam	Up to 24mJ/microbeam	Up to 70mJ/microbeam	Up to 70mJ/microbeam	Yes
Utilities	230 VAC/25A,50/60 Hz	230 VAC/25A,50/60 Hz	100-240 VAC,50/60 Hz	100-240 VAC, 50/60Hz	230 VAC/25A, 50/60Hz	Yes
Aiming Beam	Red/Green	Red/Green	--	--	==	Yes
DeliverySystem	Articulated Armor Fiber optic	Articulated Armor Fiber optic	Fiber optic	Fiber optic	Articulated Arm	Yes
Cooling System	Water to Air	Water to Air	Water to Air	Water to Air	Water to Air	Yes
Control System	Microprocessor	Microprocessor	Microprocessor	Microprocessor	Microprocessor	Yes
Energy Monitor	Display IndicatesEnergyDelivered toTissue	Display IndicatesEnergyDelivered toTissue	Display IndicatesEnergy Deliveredto Tissue	Display IndicatesEnergy Delivered toTissue	Display IndicatesEnergy Delivered toTissue	Yes
Safety	Safety Eyewearand RemoteInterlockConnector	Safety Eyewearand RemoteInterlockConnector	--	==	Safety Eyewear andRemote InterlockConnector	Yes
ConsoleDimensions	14" x 21" x 41"high	14" x 21" x 41"high	--	23" x 22" x 41" high	14" x 21" x 41" high	Yes
Weight	200 lbs	200 lbs	58 Ibs	135 lbs	200 lbs	==

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Safety andEffectiveness:	The indications for use are based upon the indications for use for predicate systems.Technologically, the JOULE ProFractional System is substantially equivalent to thelisted predicate devices. Therefore, the risks and benefits for the JOULEProFractional System are comparable to the predicate devices.
Conclusion:	JOULE ProFractional System shares similar indications for use, design features, andsimilar functional features as, and therefore is substantially equivalent to the currentlymarketed predicate devices.

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.