The Winback Back 3SE device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The Winback Back 3SE massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Description

The Winback Back 3SE generates a high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitor resistive monopolar mode and a multipolar mode. The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300 KHz to 1 MHz.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Winback Back 3SE" device, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to a predicate device (truSculpt, K133739) rather than presenting a detailed study with specific acceptance criteria and performance metrics for the Winback Back 3SE itself.

Therefore, the requested information components related to the acceptance criteria and a study proving the device meets those criteria (Table of acceptance criteria and reported performance, sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and training ground truth establishment) cannot be fully extracted or are not applicable in the context of this 510(k) submission.

Here's a breakdown of what can be inferred or explicitly stated from the document:

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

Acceptance Criteria (Inferred from Substantial Equivalence): The primary "acceptance criteria" for a 510(k) device are that it is as safe and effective as a legally marketed predicate device. This is demonstrated by showing "substantial equivalence" in intended use, technological characteristics, and safety/performance. For this device, the "acceptance criteria" would implicitly be that its performance matches or is equivalent to the predicate device, especially in its ability to elevate tissue temperature safely and efficiently.
Reported Device Performance:
- Tissue Temperature Elevation: "Results indicated satisfactory safe therapeutic increases in tissue temperature." (No specific temperature ranges or effectiveness percentages are provided, only a qualitative statement of "satisfactory safe therapeutic increases.")
- Electrical Safety & EMC: Satisfactory results against IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility: Satisfactory results for cytotoxicity, sensitization, and intracutaneous reactivity.
- Software Assessment: Addressed FDA software validation guidelines for Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing.
- Usability & Risk Management: Assessments were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated. The document mentions "volunteers of varying skin colors" for the tissue temperature elevation assessment but does not specify the number of volunteers.
Data Provenance: The tissue temperature elevation studies were conducted in "Korea & France." It is implied these were prospective studies conducted for the purpose of this submission.
Retrospective or Prospective: Implied to be prospective, as the studies "were done" for this submission.

3. 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. The document does not describe a ground truth establishment process by experts in the typical sense of diagnostic imaging or clinical outcome assessment studies. The "ground truth" for a device like this would be its physical performance, safety, and functionality, tested against engineering standards and observed physiological responses.

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

Not applicable. This concept (adjudication of expert readings) is relevant for studies where human expert interpretations are compared or pooled to establish a reference standard, typically for diagnostic devices or AI diagnostic aids. It is not described for this type of device performance testing.

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. This study type (MRMC) is generally for AI-assisted diagnostic devices where human readers interpret cases with and without AI. The Winback Back 3SE is a therapeutic device (electrosurgical cutting and coagulation, topical heating for pain relief, muscle spasms, circulation, and cellulite reduction), not a diagnostic device that assists human readers.

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

Yes, in a sense. The performance assessments (electrical safety, biocompatibility, software, electromagnetic compatibility, and the device's ability to raise tissue temperature) represent "standalone" testing of the device's inherent characteristics and functionality, independent of a human operator's diagnostic interpretation. The "Tissue Temperature Elevation Assessment" directly assesses the physical effect of the device on tissue.

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

For the performance tests:
- Electrical Safety, EMC, Software, Biocompatibility: Ground truth is established by compliance with international standards (e.g., ISO10993, IEC60601-1, IEC60601-1-2) and FDA guidelines.
- Tissue Temperature Elevation: The "ground truth" is the actual, measured increase in tissue temperature within a "safe therapeutic" range, likely determined by established physiological parameters and safety limits for RF energy application. This is a direct physiological outcome.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set in the typical sense. Its functionality is based on established RF technology.

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

Not applicable, for the same reason as point 8.

Summary

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

September 18, 2017

WINBACK USA Corp % David Furr Regulatory Correspondent FDC Services 8708 Capehart Cove Austin, Texas 78733

Re: K162828

Trade/Device Name: Winback Back 3SE Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: August 13, 2017 Received: August 16, 2017

Dear David Furr:

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 of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K162828

Device Name Winback Back 3SE

Indications for Use (Describe)

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.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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510(k) Summary Pursuant to 21 CFR 807.92

Date: August 13, 2017 K162828

1.	Submitted By:	WINBACK USA Corp302 High Plains DriveDripping Springs, TX 78620323-898-2469
2.	Contact:	David C. FurrFDC Services, LLC8708 Capehart CoveAustin, Texas 78733512-906-9654
3.	Product:	Winback Back 3SE(21CFR§878.4400) Class IIWinback Back 3SEProduct code PBX
4.	Common/Trade Name:	Massager, Radiofrequency Induced HeatWinback Back 3SE

Description:

The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300 KHz to 1 MHz.

Intended Use:

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Substantial Equivalence/Technological Characteristics:

The Winback 3SE device is substantially equivalent to the following device:

. Predicate device clearance: K133739
Trade Name: truSculpt .
Company: Cutera Incorporated .

Both devices are cart mounted consoles with electrode accessories capable of operation in monopolar and multipolar modes in the range of 300kHz to 1MHz radiofrequency.

Both devices operate in the same treatment range and voltage and feature intensity adjustments from 0 to 100% . Electrical safety and biocompatibility have been established for both devices. No direct comparison was made since there are no significant differences in operation and test results indicate identical safety.

The table below summarizes the equivalence of the devices.

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Element of Comparison	510(k) Device:	Predicate Device:	Explanation of Differences
	Winback 3SE	truSculpt, Cutera IncorporatedK133739
Regulation and ProductClassification Code	21 CFR 878.4400PBX	21 CFR 878.4400PBX	None
Indications for Use	The Winback Back 3SE deviceis intended to provide topicalheating for the purpose ofelevating tissue temperature forthe treatment of selectedmedical conditions such asrelief of pain, muscle spasms,and increase in localcirculation.The Winback Back 3SEmassage device is intended toprovide a temporary reductionin the appearance of cellulite.	The truSculpt RF energy is intendedto provide topical heating for thepurpose of elevating tissuetemperature for the treatment ofselected medical conditions such asrelief of pain, muscle spasms, andincrease in local circulation.The truSculpt massage device isintended to provide a temporaryreduction in the appearance ofcellulite.	No significantdifference forradiofrequencydevice.
Massaging Hand piece	Yes	Yes	Identical
Electrode Shapes	Square and circular	Square and rectangle	Electrode shape isnot a significantdifference
Infrared Light	No	No	Identical
Vacuum (suction)	No	No	Identical
Treatment Activation	Finger selection on console	Finger switch	No significantdifference
RF Type	Multipolar/Unipolar	Bipolar/Monopolar	No significantdifference
RF Frequency	300kHz – 1 MHz	300kHz - 50 MHz	truSculpt clearanceis for up to 50 MHzhowever actualtruSculpt productspecifications areidentical (300kHz-1MHz)
Max RF Power	300 W	300 W	Identical
Intensity Adjustment	0-100%	0-100%	Identical
Configuration	Cart mounted console withaccessories	Cart mounted console withaccessories	Identical
Patient Safety Switch	Yes	Unknown	Subject device has apatient circuitbreaker safety switch
Standards Compliance	ISO10993, IEC60601-1 &IEC60601-1-2 Compliant	ISO10993, IEC60601-1 &IEC60601-1-2 Compliant	Identical

Predicate Device Comparison Table

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Summary of Testing:

The technological characteristics of the Winback Back 3SE System has been verified based on assessments of electrical safety, performance, biocompatibility, software and usability. In addition, an assessment was done to demonstrate that the device effectively raises tissue temperature in a safe and efficient manner.

The following testing has been conducted with satisfactory results:

Back 3SE Usability & Risk Management: Usability and Risk Management ● assessments were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.
Tissue Temperature Elevation Assessment: Studies were done in Korea & France . using volunteers of varying skin colors to assess the capacity of the device to elevate tissue temperature in the treatment areas. The smallest and the largest electrodes were tested as well as the facial applicator electrode. Results indicated satisfactory safe therapeutic increases in tissue temperature.
. Biocompatibility: Samples of the tissue contacting probes were tested for cytotoxicity, sensitization and intracutaneous reactivity.
Software Assessment: Software features were assessed in accordance with FDA . software validation guidelines. Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing were all addressed.
Electromagnetic compatibility: EMC testing was done to evaluate emissions and ● immunity to electromagnetic fields in accordance with IEC 60601-1-2.
Electrical safety: Full electrical safety testing was done in compliance with IEC 60601-1.

Conclusion:

The Winback Back 3SE is substantially equivalent to the predicate device. Both devices operate in the same treatment range and voltage and feature intensity adjustments from 0 to 100%. Electrical safety and biocompatibility have been established for both 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.