The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA consists of the following components: Electrosurgical Unit - Main body, Two different handpieces ( motor and AC), Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products, Neutral electrode pad and neutral electrode pad cable, cleared under K092761, Handpiece stand, Foot switch, Power cord. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode.

AI/ML Overview

This looks like a 510(k) summary for a medical device. Based on the provided text, the device in question is the "POTENZA," an RF electrosurgical device. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/CADe devices (i.e., sensitivity, specificity, reader studies, etc.).

This document describes the regulatory process for establishing substantial equivalence to a predicate device, which primarily relies on demonstrating that the new device has similar technological characteristics and performs comparably to devices already on the market. The performance data presented here are primarily engineering bench tests, electrical safety, biocompatibility, and software validation. These are standard tests for electrosurgical devices to ensure safety and functionality, not to evaluate diagnostic performance or AI algorithm effectiveness.

Therefore, many of the specific questions you've asked, particularly those related to AI/CADe system validation (sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance), are not applicable to the information provided in this 510(k) summary for an electrosurgical device.

Here's a breakdown of what can be extracted, and why other parts are not present:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical performance metric (like sensitivity or specificity) with a target value. Instead, the acceptance criteria are implicitly met by passing various engineering and biocompatibility tests.

Test Type	Standard / Objective	Reported Device Performance
Biocompatibility (for electrode tips)	FDA's "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", June 6, 2016. Specific ISO-10993 and ASTM F756 standards for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemolysis, and Pyrogenicity.	All tests (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolysis, USP Rabbit Pyrogen) Pass.
Electrical Safety & Electromagnetic Compatibility (EMC)	IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12 (General requirements for basic safety and essential performance) IEC 60101-2-2:2017 (High-frequency surgical equipment) IEC 60601-1-2:2014 (EMC) IEC 60601-1-6:2010, AMDI:2013 (Usability)	System was tested according to these standards, implying "satisfactory" or "compliant" outcome for these safety and functional aspects (explicit "pass" not stated for each, but inferred).
Software Verification and Validation	FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern.	Conducted, implying "satisfactory" or "compliant" outcome.
Bench Testing (Output Accuracy, Frequency, Power Fluctuation, etc.)	To assure the POTENZA operates safely and within predefined design specifications. Includes thermal testing per FDA guidance.	Conducted, implying "satisfactory" or "compliant" outcome for all listed parameters: Output accuracy (Monopolar/Bipolar, 1MHz/2MHz), Frequency, Power fluctuation, Negative output protection, Impedance measurement, HO count accuracy, Safety test of warnings/failsafe, Needle depth, Motor speed level, Thermal testing.

Regarding the specific questions about AI/CADe validation:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective).
- Not applicable. This device is an electrosurgical unit, not an AI/CADe system that analyzes data like images. The "test set" here refers to physical components and the device itself undergoing engineering and biological safety tests.
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).
- Not applicable. Ground truth, in the context of AI/CADe, involves expert interpretation of data. For this electrosurgical device, "ground truth" relates to objective physical and biological properties measured by standardized tests (e.g., cytotoxicity assays, electrical measurements).
Adjudication method (e.g. 2+1, 3+1, none) for the test set.
- Not applicable. Adjudication is for resolving discrepancies in expert interpretations of data. This is not performed for physical device testing.
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.
- Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electrosurgical unit through bench and safety tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The "ground truth" for the tests performed are highly standardized scientific and engineering measurements. For example, for biocompatibility, the ground truth is whether specific biological responses (e.g., cell death, irritation) occur above a predefined threshold according to the specified ISO standards. For electrical safety, the ground truth is whether the device parameters (e.g., leakage current, output power) fall within the limits set by IEC standards.
The sample size for the training set.
- Not applicable. There is no AI training set for this electrosurgical device.
How the ground truth for the training set was established.
- Not applicable. There is no AI training set or associated ground truth.

In summary, the provided document is a 510(k) summary for an electrosurgical device, detailing its regulatory pathway to market based on substantial equivalence. It focuses on safety and fundamental performance characteristics through engineering and biocompatibility testing, not on the diagnostic accuracy or AI performance metrics you've requested.

Summary

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February 20, 2020

Jeisys Medical Incorporated % Pamela Weagraff Director, MedTech Regulatory IOVIA 18 Bridie Lane Norfolk, Massachusetts 02056

Re: K192545

Trade/Device Name: Potenza Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 20, 2020 Received: January 21, 2020

Dear Pamela Weagraff:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K192545

Device Name POTENZA

Indications for Use (Describe)

The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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510(k) Summary 1

510(K) SUBMITTER I.

a) Company Name and Address

Jeisys Medical Incorporated 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu Seoul 08501 KOREA

b) Company Contact:

Wonchel Choi, Deputy Manager, Regulatory Affairs Jeisys Medical, Inc. 811, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-gu Seoul, 08501, Korea

Phone: +82.70. 7435.4926

c) Date Prepared: February 19, 2020

II. DEVICE

Name of Device: POTENZA

Common or Usual Name: Electrosurgical coagulation device and accessories

Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400)

Regulatory Class: II

Product Code: GEI

PREDICATE DEVICE III.

a) Predicate Devices

Predicate Device 1: INTRAcel Premium Fractional RF Micro Needle (FRM) System, K153727
Predicate Device 2: InMode System with Fractora3D/3D-90 Applicators, K180189 ●

b) Reference Devices

Reference Device 1: AGNES, K160469
Reference Device 2: Secret RE , K170325 ●

1 Prepared according to FDA's "Guidance for Industry and FDA Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" July 24, 2014

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Note: none of the above mentioned devices have been subject to a design-related recall, removal or correction.

IV. DEVICE DESCRIPTION

The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.

The POTENZA consists of the following components:

o Electrosurgical Unit - Main body
o Two different handpieces ( motor and AC)
Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products
Neutral electrode pad and neutral electrode pad cable, cleared under K092761
Handpiece stand ●
o Foot switch
Power cord

The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.

The POTENZA has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of the electrosurgical device.

The clinical use model for the POTENZA is identical to that of comparable electrosurgical devices, intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

V. INDICATIONS FOR USE

The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The POTENZA compares to the predicate devices and reference devices as follows:

. The principle of operation of the POTENZA is the same as the predicate devices with respect delivery of bipolar RF energy through micro needle electrode to achieve coagulation and hemostasis. It differs from the predicate devices, in that the POTENZA also supports monopolar mode of energy delivery. Reference device 1, however also supports monopolar RF energy delivery.
Electrosurgical Unit:
- The POTENZA bipolar operating mode is the same as the predicate devices. It differs from the predicate devices in that it also supports a monopolar operating mode. Reference device 1. however, also supports monopolar RF energy delivery.
- Λ The POTENZA is the same as the predicate devices with respect to output frequency of 1MHz. It differs from the predicate devices in that it also operates at 2 MHz. however. reference device 2 also supports an output frequency of 2MHz.
- Λ The POTENZA is the same as predicate device 1 with respect to flexibility to operate up to 50 W. The sole difference is the number of levels up to 50 W, 10 versus 7 levels. However, reference device 2 also offers normal operating power over 10 levels.
- The maximum power available with the POTENZA is the same as predicate device 1. There are no differences.
- The impedance available with the POTENZA is the same as predicate device 1. There are no differences.
- The POTENZA power source is the same as predicate device 1. There are no differences.
Active Accessory (Electrode): ●
- The POTENZA bipolar operating mode is the same as the predicate devices. It differs from the predicate devices in that it also supports a monopolar operating mode. Reference device 1, however, also supports monopolar RF energy delivery.
- The POTENZA is the same as the predicate devices with respect to the electrode type. There are no differences.
- The POTENZA is the same as predicate device 1 with respect to the RF treatment area. There are no differences.
- The material of the POTENZA active electrode is the same as predicate device 1 with respect to the electrode type. There are no differences.
- The POTENZA is the same as the predicate devices with respect to the active electrode being intended for single use. There are no differences.
- The POTENZA is the same as predicate device 2 with respect to depth of Skin ablation: up to 4.0 mm. There are no differences.
Neutral Electrode Pad: the POTENZA includes a 510(k)-cleared neutral electrode pad ● for monopolar operation which is similar to the reference device 1.

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VII. PERFORMANCE DATA

a) Biocompatibility Testing

Jeisys performed biocompatibility testing for the electrode tips according to FDA's "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", June 6, 2016. Of the POTENZA components, only the electrode tips and neutral electrode pad come into direct contact with the patient. The electrode tips are external communicating devices which come into contact with tissue / bone / dentin, for a limited period of time, i.e., less than 24 hours. The neutral electrode pad is a surface device which comes into contact with intact skin, also for a limited period of time.

Since the neutral electrode pad is a purchased component and has received a 510(k) clearance decision, K092761, biocompatibility testing was not performed. The electrode tips were tested as shown in Table 1 below.

Test Type	Standard	Results
Cytotoxicity	ISO 10993-05:2009, Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicityUSP 41:2018 <87> Biological Reactivity Tests, in vitroelution test	Pass
Sensitization: Guinea PigMaximization Test (GPMT)	ISO 10993-10:2010, Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization	Pass
Irritation or IntracutaneousReactivity [AnimalIntracutaneous (Intradermal)Reactivity Test	ISO 10993-10:2010, Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization	Pass
Acute Systemic Toxicity	ISO 10993:2017, Biological evaluation of medicaldevices - Part 11: Tests for systemic toxicity	Pass
Hemolysis	ISO 10993-4, Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood	Pass
	ASTM F756, Standard Practice for Assessment ofHemolytic Properties of Materials
USP Rabbit Pyrogen	ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity	Pass
	USP, General Chapter < 151 >, Pyrogen Test

Table 1: Electrode Tips – Biocompatibility Testing

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b) Electrical safety and electromagnetic compatibility (EMC)

Electrical safety, EMC, device-related electrical safety for high frequency and usability were conducted on the POTENZA system according to the following consensus standards:

. IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
IEC 60101-2-2:2017. Medical electrical equipment Part 2-2: Particular requirements . for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements . for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests
IEC 60601-1-6:2010, AMDI:2013, Medical electrical equipment Part 1-6, General . requirements for Safety – Collateral Standard: Usability

c) Software Verification and Validation Testing

Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern.

d) Bench Testing

Jeisys conducted bench testing to assure that the POTENZA operates safely and within the predefined design specifications. Tested parameters included:

. Output accuracy (Monopolar at 1MHz and 2 MHz)
Output accuracy (Bipolar at 1MHz and 2MHz
Frequency: manual and standard ●
Power fluctuation characteristics ●
Negative output protection
Impedance measurement accuracy and range
HO count accuracy
Safety test of various warnings / failsafe mechanisms ●
Needle depth
Motor speed level
. Thermal testing in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", August 15, 2014

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e) Animal Studies / Clinical Studies

The differences between the POTENZA and the predicate and reference devices did not require animal testing or clinical testing in humans.

VIII. CONCLUSIONS

The subject POTENZA device is similar to the predicate and reference devices with respect to the principles of operation, technological characteristics, as well as performance characteristics. Non-clinical testing was conducted to evaluate the performance of subject device in comparison to the predicate device. Results of design validation and verification activities, i.e., testing to designated standards and performance testing of the devices, have demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.

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.