Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

Device Description

Apollo Duet has RF handpiece attached to the main body, and consists of an electrode cable and a power adapter. This equipment has RF mode, which is the main function, RF mode is a mode in which Radio-frequency is output in a bipolar method. An RF handpiece is used, and a high frequency is output through 4ea RF handpiece electrodes. In addition, the RF handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 45 C

AI/ML Overview

The provided text describes the regulatory clearance of a medical device called "Apollo Duet" (Model: APD-4000) by the FDA. It does not contain information about a study that proves the device meets specific acceptance criteria related to its performance in terms of effectiveness for its intended use.

The document focuses on demonstrating substantial equivalence to a predicate device (InMode RF Pro System) based on technical, safety, and operational characteristics, rather than a clinical effectiveness study with defined acceptance criteria for efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The information requested regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is not present in the provided text.

Here's what can be extracted regarding testing and related safety:

Acceptance Criteria and Study Information (Based on provided text)

The document outlines safety and performance bench testing and adherence to international standards to demonstrate substantial equivalence and safety, rather than effectiveness acceptance criteria for its therapeutic claims (relief of muscle aches, spasm, and improved blood circulation).

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

Acceptance Criteria (Implied Safety/Technical)	Reported Device Performance (Compliance)
Electrical Safety (IEC 60601-1:2005, AMD1:2012)	Complies with standard
Electromagnetic Compatibility (IEC 60601-1-2:2014)	Complies with standard
High Frequency Surgical Equipment Safety (IEC 60601-2-2:2017)	Complies with standard
Nerve & Muscle Stimulators Safety (IEC 60601-2-10:2012/A1:2016)	Complies with standard
Risk Management (ISO 14971:2019)	Risk management recorded
Usability (IEC 60601-1-6:2010 + A1:2013)	Usability documented
Biocompatibility (ISO 10993-1) (Electrode: SUS 304, LED Display: PC (SR3108FM))	Materials are biocompatible for intact skin, limited contact (<24 hours)
RF Ablation Thermal Effects (Ex-vivo testing)	Performed to compare thermal effects with predicate device
Skin Temperature Measurement	Measured with thermographic camera; output automatically turns off if skin temperature exceeds 45°C

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

RF Ablation Thermal Effects (Ex-vivo testing): Not specified (type of tissue: porcine abdominal skin).
Skin temperature measurement: 6 healthy volunteers (3 light skin, 3 dark skin). Data provenance: Not specified (implied to be from the manufacturer, WEERO Co., Republic of Korea). This appears to be a prospective safety test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not specified in the document. The tests seem to be objective measurements (e.g., temperature, compliance with standards) rather than expert-derived ground truth for performance.

4. Adjudication method for the test set:
Not applicable/Not specified.

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 study was done, as this is not an AI-assisted diagnostic device, but an electrosurgical cutting and coagulation device and accessories.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not directly applicable in the context of typical AI standalone performance. The device itself is a standalone medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For safety/technical testing, the "ground truth" is compliance with established international standards (e.g., IEC 60601 series, ISO 14971) and objective measurements (e.g., temperature thresholds). For ex-vivo testing, direct measurement of thermal effects on tissue.

8. The sample size for the training set:
Not applicable. This device does not appear to involve machine learning models that require a training set.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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August 25, 2022

Weero Co. Eunice Cho Quality Management Representative A605 VentureValley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Re: K212253

Trade/Device Name: Apollo Duet (Model : APD-4000) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: July 15, 2021 Received: July 19, 2021

Dear Eunice Cho:

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

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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 (OS) 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,

for

Colin K. Chen, Ph.D. Acting 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) K212253

Device Name Apollo Duet (Model name: APD-4000)

Indications for Use (Describe)

Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

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

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

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K212253 Exhibit 5

Date of Summary Preparation: August. 23, 2022

1. Submitter and US Official Correspondent Submitter : WEERO Co. Address: A605 VentureValley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea Telephone No.: +82-31-5182-8588

Official Correspondent: Eunice cho
Correspondent:	WEERO Co.
Address:	A605 VentureValley II, 142-10, Saneop-ro 156beon-gil,Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea
Telephone No.:	+82-31-5182-8588
Email:	eunice@weeroweero.com

2.	Device Information
	Trade/Device Name:	Apollo Duet
	Regulation Name:	Electrosurgical cutting and coagulation device and
		accessories
	Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
	Product Code:	GEI, PBX
	Device Class:	Class II per regulation 21CFR878.4400

Predicate Device(Equivalent Legally Marketed Device) 3.

Manufacturer:	InMode Ltd.
Device Name:	InMode RF Pro System
510(k) Number:	K210492
Classification:	Electrosurgical, Cutting & Coagulation & Accessories: GEI,Massager, Vacuum, Radio Frequency Induced Heat: PBXMassager, Therapeutic, Electric: ISA,Massager, Vacuum, Light Induced Heating: NUVClass II per regulation 21CFR878.4400.

1. Description of the Device
  Apollo Duet has RF handpiece attached to the main body, and consists of an electrode cable and a power adapter.

This equipment has RF mode, which is the main function, RF mode is a mode in which Radio-frequency is output in a bipolar method. An RF handpiece is used, and a high frequency is output through 4ea RF handpiece electrodes. In addition, the RF handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 45 C

1. Indications for use (intended use) Apollo duet (RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

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Apollo Duet
510(k) Summary

Substantial equivalence chart 7.

Name	Proposed device	Predicate device
Device Name	Apollo Duet (RF Mode)	InMode RF Pro System(Applicator: Forma)
Product CodeClass	GEIClass II	GEIClass II
Manufacturer	WEERO Co.	InMode Ltd.
510(k) No.	K212253	K210492
Indicationsfor use	Apollo duet(RF Mode) is intended forrelief of minor muscle aches and pain,relief of muscle spasm, and temporaryimprovement of local blood circulation.	The InMode RF Pro System with theNon-invasive RF Applicators employsRF energy for various applications:i-Forma, Forma (Plus), Plus (Plus Plus)and Plus90 for relief of minor muscleaches and pain, relief of muscle spasm,and temporary improvement of localblood circulation.
Target Population	Adults requiring treatment asspecified in the indication for use	Adults requiring treatment asspecified in the indication for use
Environment Used	Hospital or Clinic setting	Hospital or Clinic setting
Input Power	100-240V~, 50/60Hz	100-240V~, 50/60Hz
Energy Used	(Non-invasive) Bipolar RF	(Non-invasive) Bipolar RF
MaximalRF output power	40[W]	Forma: 50[W]
RF Frequency	1MHz	1MHz
Biocompatibility	Materials are biocompatible.	Materials are biocompatible.
Sterility	NA	NA
Reprocessing	Applicator to be reprocessed inaccordance with user manualinstructions.	Applicator to be reprocessed inaccordance with user manualinstructions.

The proposed device uses similar or identical technology as the predicate devices and has same intended uses. Based upon the predicted overall performance characteristics for the Apollo Duet, WEERO Co. believes that no significant differences in usage of its underlying technological principles between Apollo Duet and the predicate devices.

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Apollo Duet

510(k) Summary

8. Software / Cybersecurity

The Apollo Duet software design and development follows FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".

The Apollo Duet cybersecurity follows FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Device:.

9. Electrical Safety, Electromagnetic Compatibility Testing & Performance Data

Bench tests were conducted to verify that the proposed device met all design specifications.

Ex-vivo testing was performed to compare RF ablation thermal effects of subject device and predicate device on porcine abdominal skin tissue.

Skin temperature was measured when using the subject device on 6 healthy volunteers, including 3 people of light skin and 3 people of dark skin, with a thermographic camera at the irradiated areas on the skin.

Safety testing results demonstrated that the proposed device complies with the following standards:

Basic safety and essential performance of the Apollo Duet is tested and evaluated according to the IEC 60601-1:2005, AMD1:2012.
Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014.
Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories is tested and evaluated according to the IEC 60601-2-2:2017.
Particular requirements for the basic safety and essential performance of nerve and muscle stimulators is tested and evaluated according to the IEC 60601-2-10:2012/A1:2016.
Risk management was recorded by referring to ISO 14971:2019.
Usability was documented by referring to IEC 60601-1-6:2010(Third Edition) + A1:2013.

Biocompatibility

Part	Material	Patient Contact	Duration ofContact byISO 10993-1	Bio-compatibility
Electrode	SUS 304	Intact Skin	Limited(< 24 hours)	Yes
LED Display	PC (SR3108FM)	Intact Skin	Limited(< 24 hours)	Yes

11. Conclusion

Based on the information provided in this Summary, WEERO Co. the Apollo Duet is as safe and effective as the predicate device as indicated 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.