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The Venus Heal device is intended for the treatment of the following medical conditions; using the Large and Small applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:

• . Relief of minor muscle aches and pain, relief of muscle spasm.
• Temporary improvement of local blood circulation .
• Temporary reduction in the appearance of cellulite ●

The subject device Venus Heal system is a modification of the legally marketed Venus Legacy CX system cleared under K143554. The proposed system is a smaller and lightweight version of the previously cleared Venus Legacy CX system. The Venus Heal system consists of a console (main unit) and two applicators (Large and Small). The console design change is driven to enhance the ergonomic capabilities of the product family.

The additional changes are summarized below:
a) Ergonomics of the user interface: bigger Liquid Crystal Display (LCD) color touch screen.
c) Tissue manipulation includes manual massage only.
d) Increase of Maximal RF output power.
e) Updated software to reflect hardware changes.

The Venus Heal RF energy, pulsed magnetic fields (PMF) and tissue manipulation are utilized to trigger changes in the tissue which result in muscle spasm relief and pain relief, along with local blood circulation improvement.

Temporary reduction in the appearance of cellulite is similarly achieved by combination of these three main mechanisms: RF and Pulse Magnetic Field (PMF) delivery as well as tissue manipulation,

Consistent with the previous clearance, the system is intended to be used in professional healthcare facilities (prescription use) just as the predicate, and its major components are still the main console unit, and individual modules/hand pieces.

The Venus Heal device is intended for the treatment of minor muscle aches and pain, muscle spasm relief, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The device uses non-thermal RF, massage, and magnetic field pulses.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1 (General Requirements For Basic Safety And Essential Performance)
• IEC 60601-1-6 (General Requirements for basic safety and essential performance)
• IEC 60601-2-2 (Particular Requirements For The Basic Safety and Essential Performance Of High Frequency Surgery Equipment and High Frequency Surgical Accessories)
• IEC 60601-1-2 (Electromagnetic Compatibility Requirements and Tests). |
  | Software verification and validation. | Performed. |
  | Biocompatibility. | Confirmed using the same product material as in the predicate device. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for the benchmark test beyond "skin surface," but implies multiple measurements.
• Data Provenance: The study was a bench test, implying it was conducted in a laboratory setting by the manufacturer (Venus Concept USA Inc.). Country of origin is not specified, but the submission is to the U.S. FDA. It is a prospective test to verify performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Experts: Not applicable. The ground truth for the bench test was established through direct physical measurements of temperature and functional assessment against specified engineering and regulatory standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The performance was assessed against objective physical and engineering standards, not through expert consensus on subjective outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Yes, the described performance testing (bench tests, software verification) appears to be a standalone (algorithm/device only) performance evaluation. It assesses the device's inherent capability to meet technical specifications and safety standards independent of user interaction beyond basic operation. There is no AI component mentioned in the device description.

7. Type of Ground Truth Used

• Ground Truth Type: For the bench test, the ground truth was based on objective physical measurements (e.g., temperature readings) and engineering standards (e.g., compliance with IEC standards) as defined by the device's technical specifications and regulatory requirements.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not appear to involve a machine learning algorithm that would require a "training set." The testing performed was for device performance verification and validation against established standards.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm.

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