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The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

The Symmed Elite Aesthetic device is a radiofrequency generator that is used for a number of pain related applications such as" to relieve pain, muscle spasms and increase local circulation through electrical and thermal stimulation of the treated tissues". In addition, it contains a massage function that provides temporary improvement in the appearance of cellulite. The Symmed Elite Aesthetic consists of a console plus 2 handpieces, each with 3 different size electrodes. Each handpiece is capable of being fitted with the optional massager. This allows for flexible treatment parameters throughout the working range and handpieces.

The provided document, a 510(k) summary for the Symmed Elite Aesthetic, does not describe an AI medical device. Instead, it details a radiofrequency generator for topical heating and a massage device for cellulite reduction. Therefore, the questions related to AI device acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set data are not applicable.

However, I can extract the relevant performance testing information for the described device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Indiba Diathermia RF, K161458) through comparison of specifications and direct performance testing. While explicit "acceptance criteria" for each performance metric are not listed as pass/fail thresholds in a table, the performance testing section describes what was evaluated and the comparison table highlights areas of similarity or difference with the predicate.

Key Performance Testing Conducted (General Acceptance Criteria Implied):

• Electrical Safety & Performance:
  • IEC 60601-1:2005 (Third Edition) + A1:2012 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2014 (Electromagnetic compatibility requirements and tests)
  • IEC 60601-2-2:2017 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories)
• Biocompatibility:
  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Implies components in contact with the body are safe)
• Software Verification & Validation:
  • IEC 62304:2006/A1:2016 (Implies software functions as intended and is safe)
• Specific Device Functionality:
  • Performance testing to show that frequency, impedance, voltage output, and output power all performed within the accepted range (Implies these electrical parameters were measured and found compliant).
  • Tissue Heating Capability: The device "can maintain a skin surface temperature of 40°C for 10 minutes of treatment." (This is a specific functional acceptance criterion and was met).

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

The document states: "The Symmed Elite Aesthetic device has been validated through an in-house study to demonstrate that the device can maintain a skin surface temperature of 40°C for 10 minutes of treatment."

• Sample Size: Not specified. It's an "in-house study," which typically implies a limited number of test subjects or a bench test setup simulating skin.
• Data Provenance: "In-house study," likely conducted by the manufacturer, Termosalud, in Spain (Ataulfo Friera Tarfe, 8 - 33211 Gijón, Spain). It is a prospective test of the device's performance.

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

N/A for this type of device. There is no "ground truth" established by experts in the context of diagnostic interpretation as there would be for an AI device. The validation is based on physical measurements (temperature, electrical parameters, safety standards).

4. Adjudication Method for the Test Set:

N/A. This is not an interpretive diagnostic study requiring adjudication. Performance is measured against predefined technical specifications or the ability to achieve a physical outcome (e.g., maintaining a specific temperature).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This is not an AI device, and its performance is not assessed in terms of human reader improvement.

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

N/A. This is a physical device, not an algorithm. The device's performance is inherently standalone in its function (e.g., it heats by itself).

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering specifications, international consensus standards (IEC, ISO), and direct physical measurements (e.g., temperature, electrical outputs). For the tissue heating study, the ground truth was the measured attainment of 40°C for 10 minutes on the skin surface.

8. The Sample Size for the Training Set:

N/A. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

N/A.

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