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The Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q- Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.

The Resonic™ Rapid Acoustic Pulse (RAP) device is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of cellulite. Resonic uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in accelerated tattoo fading and fewer office visits to achieve sufficient tattoo fading. When used for improving the appearance of cellulite, the acoustic waves induce physical effects in the fibrous structures and improve the appearance of skin laxity.

The Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Handpiece and the replaceable Cartridge. The Console supplies saline to the Handpiece to enable formation of the shock wave within the acoustic pulse chamber. The Handpiece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent window of the Cartridge and acoustic ultrasound gel or similar hydrogel pad, which is placed against the surface of the skin to be treated.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The independent, blinded photo assessment study comprised 56 participants. For the primary effectiveness endpoint on skin laxity, 5 participants were excluded as they were not considered to have skin laxity, resulting in an effective sample size of 51 participants.
• Data Provenance: The images for the aesthetic study were "collected from the pivotal study that evaluated the Resonic device for improvement in the appearance of cellulite." The document does not explicitly state the country of origin or if the data was retrospective or prospective for the original pivotal study. However, the skin laxity assessment itself was a retrospective analysis of existing images.

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

• Number of Experts: Three independent, blinded physicians.
• Qualifications of Experts: The document states they were "independent, blinded physicians." Specific details regarding their specializations (e.g., dermatologists, plastic surgeons) or years of experience are not provided.

4. Adjudication Method for the Test Set

• The adjudication method was a 2 out of 3 consensus. The primary effectiveness endpoint was defined as "correct identification by at least 2 of 3 blinded reviewers of 12-week post-treatment images with respect to skin laxity from randomized groups of pre- and post-treatment images."

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or conducted. This study focused on assessing the device's direct effect on skin laxity through expert review of treated vs. untreated images.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not conducted or mentioned. The study described relies on human expert assessment of photographic images, not an AI algorithm's performance.

7. Type of Ground Truth Used

• The ground truth used was expert consensus (specifically, a 2 out of 3 consensus among independent, blinded physicians) based on the visual assessment of photographic images.

8. Sample Size for the Training Set

• The document does not mention a training set as this study does not involve an AI algorithm that would require training. The assessment was based on human expert review of clinical images.

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

• As there was no AI algorithm and therefore no training set, this information is not applicable.

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