The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.

The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for

Device Description

The Alma Diode Tabletop Laser is comprised of the following major components:

The main console unit 1.
1. Pull-back
1. Footswitch
Accessories 4.

AI/ML Overview

The provided text is a 510(k) summary for the Alma Diode Tabletop Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, the acceptance criteria and study data provided in this document pertain to the device's substantial equivalence to predicate devices based on technical characteristics and safety standards, NOT to the performance of an AI/ML algorithm or its clinical effectiveness.

Therefore, I cannot provide information on acceptance criteria for an AI/ML device, nor studies proving its performance, nor details about ground truth, expert adjudication, or MRMC studies for an AI/ML algorithm, as none of that information is present or relevant to this 510(k) submission.

The document discusses "Design Verification Testing" for the hardware component (pullback accessory) and software validation for the control software, but this is not equivalent to clinical performance studies for an AI/ML diagnostic or therapeutic algorithm.

Here's what can be extracted from the document regarding the device's (a laser system and its pullback accessory) "acceptance criteria" and "proof" of meeting them, within the context of substantial equivalence:

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

The document doesn't present "acceptance criteria" in the typical sense of quantitative performance metrics for a clinical task (like sensitivity/specificity for a diagnostic AI). Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and meeting safety standards.

The closest to "criteria" and "performance" described are:

Technical Characteristics Comparison (Table 1 - Salient Characteristics of the 1470nm module and the Predicate Devices): This table implicitly serves as the "acceptance criteria" by showing that the proposed device's characteristics (e.g., laser wavelength, max power, operation mode, fiber size, user interface) are comparable or identical to the predicate devices. The "reported device performance" is essentially the listed characteristic itself, demonstrating it falls within the range/type of the predicates.

Parameter (Implicit Acceptance Criteria)	New Device (Alma Diode Tabletop Laser - 1470nm)	Predicate Device (K13 Alma diode tabletop laser)	Predicate Device (K100558 Quanta Diode Laser Family)
Laser Wavelength [nm]	1470	1470	1470
Max power	15W	15W	15W
Light/Laser Source	Diode	Diode	Diode
Laser Delivery	Optical Fiber	Optical Fiber	Optical Fiber
Operation Mode	Continuous wave, single pulse, pulsed	Continuous wave, single pulse, pulsed	Continuous wave, single pulse, pulsed
Pulse Duration	10-990ms	3ms - 2.5s (Predicate used is K100558, not K13)	3ms - 2.5s
Bare fiber size	200, 300, 320, 400, 600, 800, 1000	200, 300, 320, 400, 600, 800, 1000	200, 300, 320, 400, 600, 800, 1000
User Interface	LCD touch screen	LCD touch screen	LCD touch screen
Aiming beam	635nm	650nm (Predicate used is K100558, not K13)	650nm
Electrical Requirements	100-240, V AC 50-60 Hz, 6.3 A	100-240, V AC 50-60 Hz, 6.3 A, single phase	100-240, V AC 50-60 Hz, 6.3 A, single phase
Indications for Use	Matching predicate (listed)	Listed	Listed

Design Verification Testing (Section VIII):
- Criterion: Actual pullback speeds match requested speeds.
- Reported Performance: "Performing mechanical tests to verify the actual pull back speeds matched the requested speeds." (No specific numerical results provided, only an assertion of matching).
- Criterion: Software fully verified and validated according to IEC 62304 and FDA guidance.
- Reported Performance: "the software controlling the Alma 1470nm diode tabletop laser with the pull-back accessory was fully verified and validated in accordance with IEC 62304 and the FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"." (Again, an assertion of compliance rather than explicit test results).
Electrical Safety and EMC Testing (Section VII):
- Criterion: Compliance with IEC 60601-1 and IEC 60601-1-2.
- Reported Performance: "Additional product electrical safety testing and EMC testing was successfully completed in accordance with the following standards: IEC 60601-1... IEC 60601-1-2..." (Assertion of successful completion).

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

Not applicable for a clinical test set in the context of an AI/ML device. The "testing" mentioned is for hardware performance and software validation of the device's control system, not for an AI algorithm's performance on clinical data.
The document implies lab-based mechanical and electrical tests. There is no information on sample size of patients or data, nor data provenance (country of origin, retrospective/prospective).

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

Not applicable. This pertains to clinical ground truth for diagnostic AI. The "ground truth" for this device's testing would be precise measurements of speed, electrical parameters, and successful software operation, established by engineers and test equipment, not clinical experts.

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

Not applicable. This pertains to expert review of clinical data, not mechanical or software validation.

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, not done. This is a laser surgical instrument, not a diagnostic AI system intended to assist human readers.

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

Not applicable in the context of AI. The device itself is a standalone instrument. Its software controls its functions, but it's not a diagnostic algorithm.

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

For the pullback accessory: The "ground truth" for pullback speed verification would be precise mechanical measurements from calibrated instruments.
For electrical safety and EMC: The "ground truth" would be standardized test procedures and measured electrical parameters against defined thresholds in the IEC standards.
For software: The "ground truth" for software validation would be software requirements specifications and its ability to consistently execute defined functions without errors.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, no AI/ML training set is involved.

In summary: The provided document is a 510(k) submission for a traditional medical device (a laser and its accessory). It focuses on demonstrating substantial equivalence to existing devices through comparison of technical specifications and adherence to engineering safety and performance standards, rather than proving the clinical performance or validation of an AI/ML algorithm. Therefore, many of the questions related to AI/ML device performance studies are not applicable to this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized graphic of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

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

May 5, 2016

Alma Ltd % Ms. Kathy Maynor Regulatory Consultant 26 Rebecca Ct Homosassa, Florida 34446

Re: K160952

Trade/Device Name: Alma Diode Tabletop Laser 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: April 1, 2016 Received: April 5, 2016

Dear Ms. Maynor:

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

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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/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) K160952 "

Device Name Alma Diode Tabletop Laser

Indications for Use (Describe)

Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.

Indications for Use

laser assisted lipolysis.

The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules:

The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.

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

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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Section 8 – 510(k) Summary or 510(k) Statement

I. General Information

Submitter:	Alma Lasers, Ltd,Halamish St. POB 30Industrial ParkCaesarea Israel 38900
Contact Person:	Kathy MaynorConsultant352-586-3113 (cell)
Summary Preparation Date:	May 4, 2016

II. Names

Device Names:	Alma Diode Tabletop Laser
Primary Classification Names:	Surgical Powered Light Instrument

III. Predicate Devices

K #	Predicate Device
K140005	ALMA DIODE TABLETOP LASER
K133774	DIOTECH CO LTD - ATOVEN

IV. Product Description

The Alma Diode Tabletop Laser is comprised of the following major components:

The main console unit 1.
1. Pull-back
1. Footswitch
Accessories 4.

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V. Indications for Use

Intended Use

The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.

Indications for Use

The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.

Diode Laser Modules:

The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.

The indications for use for the 980 nm Alma Diode Tabletop Laser include:

-The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 147 0nm Alma Diode Tabletop Laser include:

-The Alma 1470 mm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.

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VI. Summary of Technical Characteristics

Table 1: Salient Characteristics of the 1470nm module and the Predicate Devices

	K13Alma diode tabletop laser	K100558Quanta Diode Laser Family
Parameter
ProductCode &RegulationNo.	GEX21 CFR 878.4810	GEX21 CFR 878.4810
LaserWavelength[nm]	1470	1470
Max power	15W	15W
Light/LaserSource	Diode	Diode
LaserDelivery	Optical Fiber	Optical Fiber
OperationMode	Continuous wave, singlepulse, pulsed	Continuous wave, single pulse,pulsed
PulseDuration	10-990ms	3ms - 2.5s
Bare fibersize	200, 300, 320, 400, 600,800, 1000	200, 300, 320, 400, 600, 800,1000
UserInterface	LCD touch screen	LCD touch screen
Aiming beam	635nm	650nm
ElectricalRequirements	100-240, V AC 50-60 Hz,6.3 A,	100-240, V AC 50-60 Hz, 6.3A, single phase,
Indicationsfor Use	The Alma 1470nm diodetabletop laser is indicatedfor use in endovenousocclusion of the greatersaphenous vein inpatients with superficialvein reflux. The Alma1470nm diode tabletoplaser is further indicatedfor laser assistedlipolysis,	The QUANTA Diode LaserSystem is intended for deliveryof laser light to soft tissue in thecontact and non contact modeduring surgical proceduresincludingvia endoscopes. The QUANTADiode Laser System is generallyindicated for use in endovenousocclusion of the greatersaphenous vein in Patients withSuperficial Vein Reflux. TheQUANTA1470 DiodeLaser is further indicated forlaser assisted lipolysis

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Manufacturer	Alma Lasers LTD	Alma Lasers LTD	DIOTECH CO LTD
Cleared Device	KXXXXXX	K140005	K133774
System Platform	Alma Diode Tabletop Laser	Alma Diode Tabletop Laser	ATOVEN
Accessory Description	Alma Lasers Pull-BackDevice		Automatic fiber pull-back driver ATOVEN
WavelengthSupported	1470nm	810nm, 980nm, and1470nm	1470nm
Intended Use /Indications For Use	The Alma Lasers Pull-BackDevice is an accessoryintended for use inconjunction with thepreviously cleared AlmaDiode Tabletop Laser1470nm (K140005).The Alma Diode TabletopLaser 1470 nm (K140005) isintended for use indermatologic and generalsurgical procedures:endovenous occlusion ofthe greater saphenous veinin patients with superficialvein reflux, and for laserassisted lipolysis.	The Alma Diode TabletopLaser 1470 nm is intendedfor use in dermatologic andgeneral surgicalprocedures: endovenousocclusion of the greatersaphenous vein in patientswith superficial vein reflux,and for laser assistedlipolysis.	ATOVEN is a diodelaser systemdesigned to deliveryof laser light to softtissue during generalsurgery procedures.This device intendedfor treatment of refluxof the saphenousveins of thighassociated withvaricose veins andvaricosities.
Pullback Accessory
Dimensions (cm)(H x W x D)	5x20x8	NA	Unk.
Weight (kg)	~0.5	NA	Unk.
Pullback Speed(mm/sec)	4 Steps:1, 2, and 4 mm/sec	NA	6 Steps:0.5, 0.7, 1.0, 1.2, 1.5,and 2.0 mm/sec
Pullback mode	Automatic	NA	Automatic
Acceptable fiber sizes	400µm fiber600µm fiber	NA	400µm fiber600µm fiber
Mode of Action	Controls the rate of fibermovement along the veinwall providing consistentexposure and minimizingtreatment time.	NA	Controls the rate offiber movement alongthe vein wallproviding consistentexposure andminimizing treatmenttime.

Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics provided demonstrates that the Alma diode tabletop laser is substantially equivalent to the predicate devices. Additional product electrical safety testing and EMC testing was successfully completed in accordance with the following standards:

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IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety ●
. IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances -Requirements and tests

VIII. D Design Verification Testing

Design verification testing was performed for the Alma 1470mm diode tabletop laser with the pullback accessory. The testing consisted of performing mechanical tests to verify the actual pull back speeds matched the requested speeds.

Additionally, the software controlling the Alma 1470nm diode tabletop laser with the pull-back accessory was fully verified and validated in accordance with IEC 62304 and the FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

IX. Conclusion

The Alma diode tabletop laser with the pull-back accessory was found to be substantially equivalent to the predicate device.

The Alma diode tabletop laser with the pull-back accessory shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.

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.