The Surgen™ U system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface.

AI/ML Overview

Acceptance Criteria and Study for Pollogen Ltd.'s Surgen U System

Based on the provided 510(k) summary for the Pollogen Ltd.'s Surgen U System, the following information can be extracted regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards rather than specific quantitative acceptance criteria for clinical outcomes of ablation and resurfacing. However, performance tests were conducted to ensure the device functions as intended within its design specifications.

Acceptance Criteria (Implied/Tested)	Reported Device Performance
Bench Testing:
Power control and accuracy relative to user input	Verified to validate Surgen U power control and accuracy.
Maximum energy per pin not higher than 62 mJ	Verified that maximum energy per pin is not higher than 62 mJ.
Applicator pins mechanical interface with disposable tip	Verified.
Applicator HE drop test	Verified.
Disposable tip packages durability after drop tests	Verified.
HE tips (gen 12 and gen 36) capable of performing 800 pulses	Validated; electrode pins and return were not affected and remained fully intact.
Pre-clinical Study (Safety):
Inducement of expected fractional pattern at treatment site	Demonstrated.
Surrounding normal healthy tissue un-effected	Demonstrated.
Overall safety of fractional skin ablation treatment	Supported as safe and effective.
Compliance with Performance Standards:
EN/IEC 60601-1 (General Requirements for Safety)	Complies.
EN/IEC 60601-1-2 (Electromagnetic Compatibility)	Complies.
EN/IEC 60601-2-2 (Safety of high frequency surgical equipment)	Complies.

Overall Conclusion: "In all instances, the Surgen U system functioned as intended and observations were as expected."

2. Sample Size Used for the Test Set and Data Provenance

Bench Testing: No specific numerical sample sizes are provided for the individual bench tests (e.g., number of units tested for power accuracy, number of tips dropped). The tests were conducted internally by Pollogen. The data provenance is presumed to be from the manufacturer's internal testing facilities (likely Israel, as Pollogen Ltd. is based in Tel Aviv) and is retrospective in the sense that it's data generated for the submission.
Pre-clinical Study: The study was conducted on "animal (pig) skin." No specific number of animals or treatment sites is provided. This was an experimental, prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the bench tests. For the pre-clinical study, the evaluation of "expected fractional pattern" and "normal healthy tissue" would typically involve pathologists or dermatopathologists, but their number and specific qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for either the bench testing or the pre-clinical study. The evaluation of results for bench tests would likely have been based on engineering and design specifications. For the pre-clinical study, the histology evaluation would typically be performed by a single pathologist or a small group, but no method for adjudication is detailed.

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 MRMC comparative effectiveness study was conducted or described in this 510(k) summary. The device is not an AI-assisted diagnostic or therapeutic tool; it is an energy-based medical device for dermatological procedures. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.

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

The Surgen U system is not an algorithm-only device. It is a physical electrosurgical system that requires a human operator (physician) for its intended use. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for bench tests was based on engineering specifications, design parameters (e.g., maximum energy per pin), and established performance standards (e.g., ability to perform 800 pulses, durability after drop tests).
Pre-clinical Study: The ground truth for the pre-clinical study was histology data from animal (pig) skin, assessing the "expected fractional pattern at the treatment site, surrounded by normal healthy tissue."

8. The Sample Size for the Training Set

The document does not mention a training set because the Surgen U System is a hardware device and not a machine learning or AI-based system that requires a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device, this question is not applicable.

Summary

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510(k) SUMMARY Pollogen Ltd.'s Surgen U System

Applicant's name:	Pollogen Ltd.6 Kaufman St.Gibor House, P.O.B. 50320Tel AvivISRAEL 6801298Tel. (972)3-510-4110Fax (972)3-510-4112
Contact Person:	Jonathan S. KahanPartnerHogan Lovells US LLP555 Thirteenth Street, NWWashington, DC 20004Tel. (202) 637-5794Fax (202) 637-5910
Date Prepared:	December 18, 2013
Name of Device:	Surgen U system
Common or Usual Name:	Electrosurgical cutting and coagulation device and accessories
Classification:	Product Code: GEIRegulation No: 21 C.F.R. §878.4400Class: IIClassification Panel: General & Plastic Surgery

Predicate Devices

Invasix Ltd., Fractora (K102461)

Device Description

Intended Use / Indications for Use

Pollogen's Surgen U system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Technological Characteristics

The Surgen U system consists of a console, Hybrid Energy (HE) hand held Applicator, Disposable tips, Footswitch and a Patient—Controlled Manual Switch. The disposable tips

DEC 18 2013

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attach to the distal end of the applicator and are placed on the patient's skin for treatment. The tips contain a matrix of bi-polar electrode pins. The disposable tips are provided sterile and in two size options. The applicator and tips are connected to the main console unit by a cable containing electrical wiring and a connector. A Footswitch controls activation of the RF current for delivery through the applicator tips. The physician can control the parameters of the treatment through a touch-screen user interface on the main console control panel. The system also includes a Patient-Controlled Manual Switch for the patient to stop treatment in case of discomfort.

Performance Data

Pollogen conducted several performance tests to demonstrate that the Surgen U system complies with performance standards and that it functions as intended. In this submission bench testing performance data as well as histology data presented.

Several bench tests were done to support the device performance, HE Electrical . Verification was done to validate the Surgen U power control and accuracy in reference to the user's input, and verify the maximum energy per pin is not higher than 62 mJ.
HE Mechanical verification was done to validate Applicator pins mechanical interface . with disposable tip and to validate Applicator HE drop test.
. HE disposable tip drop test Verification was done to validate disposable tip packages durability after drop tests.
Performance testing of the Hybrid Energy Applicator Tips was done to validate that . the HE tips, gen 12 and gen 36, are capable of performing 800 pulses while electrode pins and return were not affected and remain fully intact.
A pre-clinical study was performed in order to evaluate the safety of Pollogen's HE . applicator for fractional skin ablation treatment. For four time points, treatment was applied on animal (pig) skin for each disposable tip. Study results demonstrate that the treatment induces the expected fractional pattern at the treatment site, surrounded by normal healthy tissue. The results of this study support the conclusion that fractional ablation treatment using Pollogen's HE Applicator is safe and effective.

In all instances, the Surgen U system functioned as intended and observations were as expected.

Performance Standards

The Surgen U system complies with the following performance standards:

EN/IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for . Safety. Collateral Standard: Safety Requirements for Medical Electrical Systems.

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EN/IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard: . Electromagnetic Compatibility - Requirements and Tests.
EN/IEC 60601-2-2 Safety of high frequency surgical equipment. .

Substantial Equivalence

The Surgen U system is as safe and effective as Invasix Ltd.'s Fractora device (K102461). The Surgen U system has the same intended use and indications for use and similar technological characteristics and principles of operation as its predicate device. The main output parameter that determines the ablative and coagulative effects is the energy per pin, which is identical for the Surgen U and the predicate device. Minor differences in the number of pins, and array dimensions, may slightly affect the number of pulses required to cover the treatment area.

The minor technological differences between the Surgen U system and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Surgen U system is as safe and effective as its predicate device. Thus, Surgen U is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Pollogen Ltd % Mr. Jonathan S. Kahan Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K131758

Trade/Device Name: Surgen U System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 8, 2013 Received: November 12, 2013

December 18, 2013

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 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

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Page 2 - Mr. Jonathan Kahan

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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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/Medica]Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131758

··· משפחת הייתה היישוב של המועד המועד המועד המועד המועד המועד המו

Indications for Use Statement

510(k) Number (if known):	K131758
Device Name:	Surgen U
Indications for Use:	Pollogen's Surgen U system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A	Digitally signed by Long H. Chen - A DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen-A 0.9.2342.19200300.100.1.1=1300369056 Date: 2013.12.18 13:11:10 -05'00'
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for BSA

(Division Sign-off)

Division of Surgical Devices

510(k) Number: K131758

Page ___ of ___

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Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.