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The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.

The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The Transform Applicator in EMS mode is intended for:

• . Relaxation of muscle spasms
• . Prevention or retardation of disuse atrophy
• . Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion ●
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●

The Transform Applicator in TENS mode is intended for:

• Symptomatic relief and management of chronic, intractable pain
• . Post-surgical acute pain
• . Post-trauma acute pain

Additionally the Transform Applicator in sequential RF/EMS mode is intended for:

• . Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen ●

The Evolve System with the Transform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-cleared Evolve System platform (K210877).

The Evolve System includes the following components:

• LCD display touch screen, ●
• Audio loudspeaker,
• 48V AC/DC power supply, ●
• Real time controller, distributor card and 2 RF generators, .
• . Fans

The System operates while connected to the Transform Applicator.

The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.

The provided text describes the regulatory clearance of "The Evolve System with the Transform Applicator" and includes information about its performance data to demonstrate safety and efficacy. However, it does not present acceptance criteria in a formal table or describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it explicitly define "acceptance criteria" for the clinical study results.

Based on the information provided, here's an attempt to answer your questions, interpreting some elements from the clinical study summary:

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

The document doesn't explicitly define "acceptance criteria" with numerical thresholds for performance. Instead, it states that "The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70%" for the photographic assessment. For the primary outcome (circumference measurement), it broadly states "Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other."

Without explicit pass/fail criteria from the submission, we can infer the "reported device performance" based on the study outcomes:

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

• Sample Size for Test Set: 44 subjects.
• Data Provenance: Prospective, multi-site, single-arm clinical study. The country of origin of the data is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Three blinded evaluators were used to assess the "before and after 3 months photographs."
• Qualifications of Experts: The qualifications of these experts are not explicitly stated (e.g., radiologist with 10 years of experience). They are only referred to as "blinded evaluators."

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

The document states that "Three distinct measurements were used to evaluate fat reduction: circumference measurement by measurement tape (primary endpoint), fat thickness caliper measurement, and fat layer ultrasound measurement. Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other." It also mentions that "Before and after 3 months photographs were assessed by three blinded evaluators."

The method for reconciling differences between the three evaluators for the photographic assessment, or if simple majority or consensus was used, is not specified. Therefore, the adjudication method is unclear from the provided text.

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

The provided text describes a single-arm clinical study evaluating the Evolve System with the Transform Applicator. It does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The study focuses solely on the device's performance in achieving non-invasive lipolysis and circumference reduction.

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

This device is not an AI algorithm but a physical device that delivers RF and EMS energy. Therefore, the concept of "standalone (algorithm only)" performance does not directly apply here in the way it would for a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The study assesses the device's effect on patients.

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

The ground truth for the efficacy evaluation was based on clinical measurement and observation data:

• Circumference measurement by measurement tape (primary endpoint)
• Fat thickness caliper measurement
• Fat layer ultrasound measurement
• Assessment of before and after photographs by three blinded evaluators.
• Patient-reported comfort and satisfaction.

8. The sample size for the training set

The provided text describes a clinical study validating the device's effectiveness. It does DNOT refer to a "training set" in the context of an AI/ML model. The 44 subjects are part of the performance data or test set for demonstrating the device's clinical efficacy.

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

As there is no training set discussed in the context of an AI/ML model, this question is not applicable based on the provided document. The study is a clinical validation of a physical medical device.

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