(88 days)
The Soliton 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 1 year of observation.
The Soliton Resonic™ Rapid Acoustic Pulse 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, such as the fibrous septa in the subcutaneous tissue.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Soliton Resonic™ Rapid Acoustic Pulse Device
Intended Use: Long-term improvement in the appearance of cellulite.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Effectiveness) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: A blinded physician panel correctly identifies long-term (>52-weeks) post-treatment photographs. (Specific threshold for correct identification is not explicitly stated as a percentage in the acceptance criteria, but implied by the reported performance). | The blinded physician panel correctly identified the long-term (>52-weeks) post-treatment photograph in 95.2% of the cases. |
| Mean Cellulite Severity Score Reduction: (Specific target reduction not explicitly stated, but implied as a measure of improvement). | The mean cellulite severity score reduction was 1.09. |
| Patient Satisfaction (at 52 weeks): Implied, as the study collected patient satisfaction responses and aimed to demonstrate maintained treatment benefits. (Specific percentage target not explicitly stated in acceptance criteria). | At 52 weeks, all participants found their treatment areas to appear improved compared to the pre-treatment photos, and 97.6% of participants found there was good improvement in the appearance of cellulite. |
| Safety: No significant adverse events, or only mild/moderate expected adverse events. (Implied, as safety is always a key consideration for medical devices). | All adverse events observed were categorized as mild or moderate and were expected. No adverse events were related to the device. There were no serious adverse events. |
| Long-Term Improvement: Demonstrates no significant reduction in treatment benefits up to 1 year of observation. (This is the overarching acceptance criteria for the new indication). | The reported performance data (95.2% correct identification, 1.09 mean severity reduction, high patient satisfaction, and maintained safety profile) collectively demonstrates that the treatment effect with Resonic RAP device in improving the appearance of cellulite is maintained through 1 year after the treatment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: A total of 67 participants were enrolled.
- Data Provenance:
- Country of Origin: United States (4 sites in the United States).
- Retrospective or Prospective: Prospective multi-site trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "Blinded independent reviewers" and "blinded physician panel." The exact number of individuals on the panel is not specified in this document.
- Qualifications of Experts: They were described as "blinded independent reviewers" and "blinded physician panel." While the specific medical specialty (e.g., dermatologist) or years of experience are not explicitly stated, the term "physician panel" implies qualified medical professionals.
4. Adjudication Method for the Test Set
The adjudication method is implied as "blinded independent reviewers" or a "blinded physician panel" assessing photographs. The specific scheme (e.g., 2+1, 3+1) for resolving disagreements among multiple reviewers is not explicitly stated. It just mentions they "assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study comparing human readers with vs. without AI assistance was not done.
This study focused on the effectiveness of the device itself (Resonic RAP) for improving cellulite appearance, as assessed by a blinded physician panel, not on human reader performance assisted by the device or AI. The device is not an AI diagnostic tool that "assists" human readers in making diagnoses. It's a treatment device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable in the conventional sense for an AI device. The Resonic RAP device is a physical acoustic pulse device, not an AI algorithm. Its performance is inherent in its physical operation, not an output from a standalone algorithm. The "standalone" aspect in this context refers to its use as a "standalone device to improve the appearance of cellulite" as opposed to an accessory for tattoo removal, but this is a treatment application, not a diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for effectiveness was established by:
- Expert Consensus/Assessment: Assessment of serial clinical photographs by a "blinded independent reviewers" or "blinded physician panel" to identify post-treatment images and evaluate cellulite severity reduction.
- Patient Reported Outcomes: Patient satisfaction surveys were used to assess participants' perception of improvement.
8. The Sample Size for the Training Set
Not applicable/Not provided within this document. This document describes a clinical study for a physical medical device (Resonic RAP), not the development or validation of a machine learning algorithm that requires a separate training set. The "training set" concept is typically relevant for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, this document does not describe the development of an AI/ML algorithm with a training set.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.