The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types

Device Description

The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types. The mechanism of action of the Subject Device involves the delivery of thermal energy to the subcutaneous tissue and the deep dermis. The Device utilizes the electromagnetic waves originated from two poles: a single electrode on the handpiece that contacts the skin and a grounding reference plate (monopolar RF), or two electrodes of the handpiece placed over the treatment area (bipolar RF). Medical RF is equipped with three types of handpieces: Two monopolar handpieces (small and medium) and one bipolar handpiece; all of them contain a sensor temperature used by the DTC (Derma Temperature Control) technology. The DTC is an innovative system that instantly detects the temperature of the skin and regulates the power emissions to maintain (at the same value) the transferred temperature of RF during the treatment. The DTC system allows the operator to know the real-time temperature of the skin surface, there is no further need to manually regulate the power according to the temperature changes during the treatment session. DTC technology ensures the safety and effective functioning of the Subject Device. The user always knows the real-time temperature on the skin during the treatment and does not have to manually change the power emissions in relation to the patient's perception of heat, thereby improving the efficacy of the treatment. The Subject Device is recommended to be used by trained and qualified personnel only and includes a dedicated software (interface RS-232), installed by the manufacturer in the device's memory.

AI/ML Overview

I am unable to provide a comprehensive answer to your request because the provided text describes a 510(k) premarket notification for a medical device (Medical RF) and states that "Results of the clinical testing demonstrated that the Subject Device is safe and effective for its intended use." However, the document does NOT contain a table of acceptance criteria, nor does it explicitly detail the study that proves the device meets specific acceptance criteria in the format you've requested.

Here's what I can extract from the provided text and why I cannot complete the table or provide all the requested details of a study that proves device meets criteria:

Device: Medical RF

Intended Use: Non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types.

What the document does describe related to performance (but not as formal acceptance criteria table):

Clinical Evaluation: A clinical study was conducted.
Success Metric: "Any wrinkle score improvement (downgrade score >1) following the last treatment and at the follow-up visit, relative to pre-treatment wrinkle (baseline) score, was considered a success."
Result: "Analysis of photographic results reveals improvements in facial wrinkles (downgrade of at least 1 score, according to the Fitzpatrick scale) in all (100%) patients according to the clinical assessment."
Statistical Significance: "Score differences were found to be statistically significant while comparing baseline scores to the scores obtained at the end of treatment (p<0.05) and at the follow-up visit (p<0.05), thus confirming the treatment efficacy."
Safety: "The study revealed no adverse events during the follow up of 4 to 6 months after the conclusion of the treatment." and "Almost all patients marked the pain level with a 0 or 1 score, which corresponds to a slight sensation of discomfort and/or pain." and "The results obtained showed improvement in the appearance of wrinkles. The study confirms that treatment using the Medical RF system is safe and effective for the improvement of wrinkles and rhytides."

Based on the provided text, I cannot generate the requested table of acceptance criteria or fully address all aspects of the study that proves the device meets them because this information is not present in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, supported by clinical performance results.

Here's what I can provide based on the given text, and what is explicitly missing:

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

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Efficacy:
Wrinkle score improvement (downgrade >1 from baseline)	100% of patients showed improvement (downgrade of at least 1 score on Fitzpatrick scale)
Statistical significance of improvement (p<0.05)	Score differences statistically significant (p<0.05) at end of treatment and follow-up.
Safety:
Absence of adverse events	No adverse events reported during 4-6 month follow-up.
Minimal pain perception	Almost all patients rated pain 0 or 1 (slight sensation of discomfort/pain).
Absence of visual skin responses (edema, erythema, scarring, etc.)	(Implicitly met as no adverse events reported)

Missing: The document does not explicitly state these as pre-defined "acceptance criteria" with specific numerical targets (e.g., "minimum 80% of patients must show wrinkle improvement"). Instead, it reports the observed performance and concludes efficacy and safety.

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

Sample Size: 40 samples (two samples from each of the 20 patients).
Data Provenance: Not explicitly stated (e.g., country of origin). It is a clinical evaluation of the device.
Retrospective/Prospective: Implied prospective as it's a "clinical evaluation" conducted to gather performance data for the submission.

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

Number of Experts/Physicians: Two physicians.
Qualifications: Not explicitly stated beyond "physicians."

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

Adjudication Method: Not explicitly stated. The assessment was done "by the doctors, following the examination of the treated areas and the related photos." It does not mention a consensus or adjudication process if their assessments differed.

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

MRMC Study: No. This device is a treatment device (Medical RF), not an AI-assisted diagnostic or imaging device. The clinical study described evaluates the device's effect on wrinkles, not human reader performance.

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

Standalone Performance: Not applicable. This is a medical device for treatment, not an algorithm, and it requires clinical application by trained personnel. While it has an internal "DTC system" (Derma Temperature Control), the "standalone" concept as applied to AI algorithms doesn't fit here.

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

Type of Ground Truth: Expertise-based assessment using standardized scales:
- Wrinkle assessment: "Fitzpatrick Wrinkle Assessment (for I to IV Fitzpatrick Skin Types) or Glogau scale."
- Assessment performed by "the doctors" based on examination and "related photos, before and after treatments."
- Pain assessment: Patient self-reported on a "0 to 4 scale."
- Side effects: "visually assessing skin responses."

8. The sample size for the training set

Training Set Sample Size: Not applicable/Not provided. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm whose performance depends on a training set. The device has internal software, but the document does not describe "training" in the context of machine learning.

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

Ground Truth for Training Set: Not applicable/Not provided (as per point 8).

In summary, the provided document focuses on the safety and effectiveness of a non-invasive RF device for wrinkle treatment, demonstrating substantial equivalence to predicate devices based on its technological characteristics and a clinical study. It does not provide the kind of detailed AI/ML model validation information you've requested.

Summary

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November 6, 2020

Triworks Group S.r.l. % Parul Chansoria Elexes Medical Consulting 453 West San Carlos Street San Jose, California 95110

Re: K192621

Trade/Device Name: Medical RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 2, 2020 Received: October 2, 2020

Dear Parul Chansoria:

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.

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

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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 medical devices and radiation-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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Indications for Use

510(k) Number (if known) K192621

Device Name Medical RF

Indications for Use (Describe)

The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types

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

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

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510(k) Summary K192621

5.1 Submitter's Information

Triworks Group S.r.l. Registered Office: Via L.Belpulsi 3-86100 Campobasso. Italy Operating Office: Via Don G.Mucciardi 5-86020 Campochiaro (CB), Italy

Contact Person

Parul Chansoria Elexes Medical Consulting Telephone: 408-475-8091 E-mail: parul@elexes.com

Summary Prepared: Nov 3, 2020

5.2 Device Information

Common/ Usual Name: Electrosurgical, cutting and coagulation and device and accessories Trade Name: Medical RF Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Classification Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400

5.3 Predicate Device Information

The Medical RF (Subject Device) is substantially equivalent to the following cleared devices:

Company	Predicate Priority	Product	510(k) Number
Alma Lasers, Ltd.	Primary Predicate	Accent	K070004
Lumenis, Inc	Secondary Predicate	Aluma Skin Renewal System	K051214
BTL Industries, Ltd.	Tertiary Predicate	Exilis	K092191

5.4 Device Description

The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types.

The mechanism of action of the Subject Device involves the delivery of thermal energy to the subcutaneous tissue and the deep dermis. The Device utilizes the electromagnetic waves originated from two poles: a single electrode on the handpiece that contacts the skin and a

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grounding reference plate (monopolar RF), or two electrodes of the handpiece placed over the treatment area (bipolar RF).

Medical RF is equipped with three types of handpieces: Two monopolar handpieces (small and medium) and one bipolar handpiece; all of them contain a sensor temperature used by the DTC (Derma Temperature Control) technology. The DTC is an innovative system that instantly detects the temperature of the skin and regulates the power emissions to maintain (at the same value) the transferred temperature of RF during the treatment.

The DTC system allows the operator to know the real-time temperature of the skin surface, there is no further need to manually regulate the power according to the temperature changes during the treatment session. DTC technology ensures the safety and effective functioning of the Subject Device. The user always knows the real-time temperature on the skin during the treatment and does not have to manually change the power emissions in relation to the patient's perception of heat, thereby improving the efficacy of the treatment.

The Subject Device is recommended to be used by trained and qualified personnel only and includes a dedicated software (interface RS-232), installed by the manufacturer in the device's memory.

5.5 Indications for use

The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types.

5.6 Technological Characteristics w.r.t Predicate Devices

The Indications for Use, key technological characteristics, and operating principle of the Subject Device (Medical RF) are equivalent to the Primary and the Secondary Predicate Devices.

Table 2: Substantial Equivalence w.r.t. Predicates
Title	Subject device	PrimaryPredicate	SecondaryPredicate 1	Tertiary Predicate 2	Comparison
Manufacturer	Triworks GroupS.r.1	Alma LasersLtd.	Lumenis Inc.	BTL IndustriesLtd.	---
Device Name	Medical RF	Accent	Aluma SkinRenewalSystem	Exilis	---
510(k) Number	K192621	K070004	K051214	K092191	---
Product Code	GEI	GEI	GEI	GEI	Equivalent
RegulatoryNumber	878.4400	878.4400	878.4400	878.4400	Equivalent
Regulatory Class	II	II	II	II	Equivalent
Indications forUse	The Medical RFis a non-invasivedevice intendedfor use inDermatologicand GeneralSurgicalnon-invasivetreatmentprocedures ofwrinkles andrhytides for I toIV FitzpatrickSkin Types.	The Accent isintended for usein Dermatologicand GeneralSurgicalprocedures fornon-invasivetreatment ofwrinkles andrhytides usingcombinedtreatment withUnipolar andBipolar.	The AlumaSkinRenewableSystem is anon-invasivedevice intendedfor use inDermatologicand GeneralSurgicalproceduresnon-invasivetreatment ofwrinkles andrhytides.	The EXILISdeviceis indicated foruse innon-invasivedermatologicand generalsurgicalprocedures.	Equivalent
Performance Characteristics
Energy source	Radiofrequency	Radiofrequency	Radiofrequency	Radiofrequency	Equivalent
RF Power	200 W	200 W-300 W	2 W-10 W	170 W	Same asPrimaryPredicate andsimilar toTertiaryPredicate
OutputRadiofrequency	470 KHz	40680 KHz(±2 KHz)	468 KHz	3400 KHz	Similar withPrimary andSecondaryPredicates asit falls withinthe range ofthe PrimaryPredicate, andthe range ofSecondaryPredicate isslightly lowerthan theSubjectDevice.
Input Voltage	110-240 VAC50-60 Hz	100-120 VAC,5 A,50-60 Hz208-240 VAC,5 A, 50-60 Hz	120 VAC ±10%, 60 Hz,12A	110-240 VAC50-60 Hz	Equivalent
RF Handpiece	Bipolar,Monopolar(small andmedium)	Bipolar,Unipolar(monopolar)	Bipolar (smalland large)	Unipolar(monopolar)	Same asprimaryPredicate andsimilar toSecondaryand tertiaryPredicates.
Waveforms	Radiofrequencycurrents havingfrequency, time,modulation, andcirculation asdecided by theoperatoraccording to thespecific medicalprotocol definedby the therapy.	Radiofrequencycurrents havingfrequency, time,modulation, andcirculation asdecided by theoperatoraccording to thespecific medicalprotocol definedby the therapy.	Radiofrequencycurrents havingfrequency,time,modulation,and circulationas decided bythe operatoraccording to thespecificmedicalprotocoldefined by thetherapy.	Radiofrequencycurrents havingfrequency, time,modulation, andcirculation asdecided by theoperatoraccording to thespecific medicalprotocoldefined by thetherapy.	Equivalent
ProgrammableLogicController	PIC(ProgrammableInterfaceController)providing thesafety functionof the system	Programmedtreatmentprotocols	PLC providingthe safetyfunction of thesystem	DTC providingthe safetyfunctionof the system	Different butdoes notraise newquestions ofsafety orefficacybecause theDTC of theSubjectDevice(MedicalRF) detectsinstantly thetemperatureof the skinsurface andconsequentlyregulates thepoweremission.

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5.7 Performance Data

Medical RF complies with the applicable standards for Electrical Safety, Electromagnetic Compatibility, and Biocompatibility to demonstrate the safety and effectiveness of the device.

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Results of the clinical testing demonstrated that the Subject Device is safe and effective for its intended use. The supplied Instructions for Use provide the user with the applicable warnings and cautions during use. There are no new safety or effectiveness issues related to this device.

5.8 Clinical Evaluation

The clinical evaluation was conducted on a total of 40 samples (two samples from each of the 20 patients, performed by two physicians). The study population consisted of both genders, within the age range of 33 to 68, in good health. The study was designed by considering the real scenario of the aesthetic treatments with RF energy, and to include all types and degrees of skin wrinkles, rhytides, and other imperfections. An improvement of wrinkles was evaluated by a score value which was assessed by the doctors, following the examination of the treated areas and the related photos, before and after treatments, in accordance with the Fitzpatrick Wrinkle Assessment (for I to IV Fitzpatrick Skin Types) or Glogau scale. Anv wrinkle score improvement (downgrade score >1) following the last treatment and at the follow-up visit, relative to pre-treatment wrinkle (baseline) score, was considered a success. The study revealed no adverse events. during the follow up of 4 to 6 months after the conclusion of the treatment.

The assessment for side effects was made by visually assessing skin responses, including edema, erythema, scarring, hypopigmentation, hyperpigmentation, and textural changes immediately after the treatment. Adverse event outcomes were calculated by each physician according to the level of pain perceived by the patients; the subjects were asked to rate their pain on a 0 to 4 scale. Almost all patients marked the pain level with a 0 or 1 score, which corresponds to a slight sensation of discomfort and/or pain.

All the 20 patients enrolled had successfully completed the treatments. Analysis of photographic results reveals improvements in facial wrinkles (downgrade of at least 1 score, according to the Fitzpatrick scale) in all (100%) patients according to the clinical assessment. Score differences were found to be statistically significant while comparing baseline scores to the scores obtained at the end of treatment (p<0.05) and at the follow-up visit (p<0.05), thus confirming the treatment efficacy. At the follow-up visit in four/five/six months, the subjects reported the same or additional improvements of facial wrinkles.

The results obtained showed improvement in the appearance of wrinkles. The study confirms that treatment using the Medical RF system is safe and effective for the improvement of wrinkles and rhytides.

5.9 Conclusion

Medical RF is substantially equivalent to the Predicate Devices in terms of technological characteristics, performance characteristics, system operating ranges, user interface characteristics and intended use. Performance testing demonstrates that Medical RF is as safe and effective as the Predicate Devices.

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.