Volnewmer™ is a noninvasive monopolar radiofrequency (RF) therapy system. The radiofrequency output of the device is 6.78 MHz, and the maximum output power is 115 W.

. Volnewmer™ delivers radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis.
Volnewmer™ delivers energy from the disposable/reusable tip to the patient.
. Volnewmer™ employs radiofrequency tuning to provide radiofrequency energy across a range of impedances for delivery to the patient through the disposable/reusable tip.
Volnewmer™ consists of the following components:
Console ●
. Handpiece x2
Treatment Tips ●
Accessories:
- Return Pad -
- Return Pad Cable -
- Coupling Gel -
- Footswitch -

AI/ML Overview

The provided text, K240248, is an FDA 510(k) clearance letter for the Volnewmer™ device, an electrosurgical cutting and coagulation device. It details the device's characteristics, its comparison to predicate devices, and a summary of non-clinical testing performed to demonstrate substantial equivalence.

However, the document specifically states "Summary of Non-Clinical Testing" and explains that "Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device." It then lists tests like EMC, electrical safety, thermal effect & safety in-vivo test, bench testing, biocompatibility, and software verification/validation.

Crucially, the document does NOT contain information about acceptance criteria or specific studies that prove the device meets acceptance criteria related to a clinical performance study involving human subjects or AI performance. The questions you've posed, particularly those regarding sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for training/test sets, are typical for the evaluation of AI/ML-enabled medical devices or diagnostic devices with clinical performance claims. This document pertains to a Class II electrosurgical device that relies on non-clinical testing and comparison to predicates for substantial equivalence, not a device with such complex performance metrics.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to address the points based only on the information available in the given document:

Acceptance Criteria and Device Performance (Based on provided Non-Clinical Testing):

Since this is a 510(k) for an electrosurgical device cleared based on substantial equivalence and non-clinical testing, the "acceptance criteria" discussed are largely related to safety and fundamental performance characteristics as demonstrated through engineering tests and comparison to predicates, rather than clinical efficacy metrics (like sensitivity, specificity, accuracy, or improvements from AI assistance) which would require clinical studies.

The document implicitly states that the acceptance criterion for the non-clinical tests was that the device performs as intended and meets design specifications and that the differences (from predicate) do not raise any new issues of safety or effectiveness.

Here's a table reflecting what can be inferred as acceptance criteria and reported performance from the "Summary of Non-Clinical Testing" section:

Acceptance Criteria (Inferred from Non-Clinical Tests)	Reported Device Performance (Summary of Test Results)
Compliance with Electrical Safety Standards (e.g., IEC 60601-1, IEC 60601-1-2)	EMC and Electrical safety of the subject device was tested in compliance with IEC 60601-1 Edition 3.2; IEC 60601-1-2 Edition 4.0 and IEC 60601-2-2 Edition 6.0 (Implies successful compliance).
Acceptable Thermal Effect & Safety Profile (In-Vivo)	Thermal Effect & Safety In-Vivo Test were conducted for evaluating the safety and performance profile of the subject device. The test results support the substantial equivalence. (Implies positive results demonstrating safety and performance comparable to expectations for substantial equivalence).
Device Performs as Intended and Meets Design Specifications (Bench Testing)	Bench testing was performed to ensure that the subject device performs as intended and meets design specifications. (Implies successful performance against design specifications).
Biocompatibility of Patient-Contacting Components	Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." to demonstrate biocompatibility of the patient-contacting components of the device. (Implies successful demonstration of biocompatibility).
Software Verification and Validation as per FDA Guidance (Enhanced Documentation)	Software Verification and Validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (issued on June 14, 2023). The software documentation level for the subject device is considered as 'Enhanced Documentation'. (Implies successful and documented V&V commensurate with the 'Enhanced' documentation level, suggesting software reliability and proper function for its intended purpose within the device).
Differences from Predicate Device Do Not Raise New Safety/Effectiveness Issues	Non-clinical test results demonstrate that the Volnewmer™ safety and performance are substantially equivalent to the predicate device for the requested indications for use. (Overall conclusion based on all non-clinical tests).

Since the document focuses on non-clinical testing for a device leveraging substantial equivalence, the following points address what is not present in the provided text:

Sample size used for the test set and the data provenance: Not applicable/not mentioned. The "test set" here refers to non-clinical tests (e.g., electrical safety tests, bench tests, in-vivo thermal tests on an animal model, likely, although not explicitly stated). No human patient "test set" data for clinical performance is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This type of information is relevant for AI/ML or diagnostic devices where human expert consensus often forms the ground truth for clinical evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
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, an MRMC study was not done (or at least not reported in this document). This device is not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not mentioned for clinical performance. For the non-clinical tests, the "ground truth" would be established by validated test methodologies and engineering specifications.
The sample size for the training set: Not applicable/not mentioned. This device is not an AI/ML device that requires a training set in the typical sense (e.g., for image recognition). Its software undergoes verification and validation, but not machine learning model training.
How the ground truth for the training set was established: Not applicable/not mentioned.

In summary, the provided FDA 510(k) clearance letter for the Volnewmer™ device focuses on non-clinical performance and substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating its efficacy or the performance of an AI/ML component. Therefore, the detailed questions regarding clinical test sets, expert ground truth, and AI training data are not addressed by this type of regulatory submission document.

Summary

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April 29, 2024

Classys Inc. James Hoon Lim Regulatory Affairs Team Manager, Classys Inc. 208 Teheran-ro. Gangnam-gu Seoul. 06220 Korea, South

Re: K240248

Trade/Device Name: Volnewmer™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 30, 2024 Received: January 30, 2024

Dear James Hoon Lim:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.29 09:23:20 -04'00 Mark Trumbore, 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Submission Number (if known)

Device Name

Volnewmer TM

Indications for Use (Describe)

Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.

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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The assigned 510(k) Number: K240248

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Name: CLASSYS Inc.
. Address: 208 Teheran-ro, Gangnam-gu, Seoul, Republic of Korea
. Postal Code: 06220
General Telephone: +82-2-1544-3481 .

Contact Person:

Contact Person: Mr. James Hoon Lim (RA Team Manager, Classys)
Tel: +82-10-3351-1414
Email: h.lim@classys.com

2. Date of the summary prepared: April 25, 2024

3. Subject Device Information

Type of 510(k): Traditional ●
Trade Name: Volnewmer™ ●
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories ●
Common Name: Radio Frequency Therapy System ●
Review Panel: General & Plastic Surgery ●
Product Code: GEI ●
Regulation: 21 CFR 878.4400 ●
. Regulatory Class: Class II

4. Predicate Device Information

510(k) Number: K170758
Trade/Device Name: Thermage FLX System .
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories ●
Regulatory Class: Class II ●
Product Code: GEI, ISA ●
Manufacturer: Solta Medical, Inc.

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5. Reference Device Information

. 510(k) Number: K211562
Trade/Device Name: Virtue RF ●
Regulation Number: 21 CFR 878.4400 .
Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories ●
Regulatory Class: Class II ●
. Product Code: GEI
Manufacturer: ShenB Co., Ltd. .

6. Device Description

Volnewmer™ is a noninvasive monopolar radiofrequency (RF) therapy system. The radiofrequency output of the device is 6.78 MHz, and the maximum output power is 115 W.

. Volnewmer™ delivers radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis.
Volnewmer™ delivers energy from the disposable/reusable tip to the patient.
. Volnewmer™ employs radiofrequency tuning to provide radiofrequency energy across a range of impedances for delivery to the patient through the disposable/reusable tip.

Volnewmer™ consists of the following components:

Console ●
. Handpiece x2
Treatment Tips ●
Accessories:
- Return Pad -
- Return Pad Cable -
- Coupling Gel -
- Footswitch -

7. Indications for Use

Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.

8. Comparison to Predicate Device

The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

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		K240248	Page 3 of 4
ComparisonItem	Proposed Device,VolnewmerTM	Predicate Device,Thermage FLX System,	Reference Device,Virtue RF
510(k)Number	K240248	K170758	K211562
Trade/DeviceName	VolnewmerTM	Thermage FLX System	Virtue RF
RegulationNumber	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
RegulationName	Electrosurgical Cutting andCoagulation Device andAccessories	Electrosurgical Cutting andCoagulation Device andAccessories	Electrosurgical Cutting andCoagulation Device andAccessories
RegulatoryClass	Class II	Class II	Class II
Product Code	GEI	GEI, ISA	GEI
Manufacturer	CLASSYS INC., Inc.	Solta Medical, Inc.	ShenB Co., Ltd.
IndicationFor Use /Intended Use	Dermatologic procedures forelectrocoagulation andhemostasis of soft tissue.	Dermatologic and generalsurgical procedures forelectrocoagulation andhemostasis of soft tissue.	The Virtue RF System isintended for use indermatologic and generalsurgical procedures forelectrocoagulation andhemostasis.
OutputFrequency	6.78MHz	6.78MHz	0.5 MHz ~ 2 MHz
Max OutputPower	115 W	400 W	220 W
UserInterface	LCD TouchscreenTechnology for userinteraction and controls.	LCD TouchscreenTechnology for userinteraction and controls.	LCD TouchscreenTechnology for userinteraction and controls.
TipSpecification	• 0.25 cm2• 3 cm2• 4 cm2• 16 cm2	• 0.25 cm2• 3 cm2• 4 cm2• 16 cm2	• 2.78 cm2 / 36pin• 3.12 cm2 / 12pin• 6 cm2 / 36pin
CoolingMechanism	Water cooling system	R-134A Cryogen GasCooling	Water cooling system

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9. Summary of Non-Clinical Testing

Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device.

EMC and Electrical safety of the subject device was tested in compliance with IEC 60601-1 Edition 3.2; IEC 60601-1-2 Edition 4.0 and IEC 60601-2-2 Edition 6.0

Thermal Effect & Safety In-Vivo Test were conducted for evaluating the safety and performance profile of the subject device. The test results support the substantial equivalence.

Bench testing was performed to ensure that the subject device performs as intended and meets design specifications.

Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued on September 8, 2023) to demonstrate biocompatibility of the patient-contacting components of the device.

Software Verification and Validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (issued on June 14, 2023). The software documentation level for the subject device is considered as 'Enhanced Documentation'.

11. Conclusion

The Volnewmer™ shares the same indications for use, fundamental scientific technology, design and functional features. Non-clinical test results demonstrate that the Volnewmer™ safety and performance are substantially equivalent to the predicate device for the requested indications for 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.