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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.

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.

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.

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