(25 days)
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 1 year of observation.
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, such as the fibrous septa in the subcutaneous tissue.
The Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Hand Piece and the Cable connecting the Hand Piece to the Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent window and acoustic ultrasound gel or similar hydrogel pad, which is placed against the surface of the skin to be treated.
The provided text describes the regulatory clearance of the Resonic Rapid Acoustic Pulse device, specifically focusing on a software modification to change the pulse repetition rate for cellulite treatment from 50Hz to 100Hz. The information primarily relates to demonstrating substantial equivalence to a predicate device rather than a comprehensive study for initial device approval.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the clinical study. Instead, it describes a "primary effectiveness endpoint" and the results of a comparison study.
| Acceptance Criteria (Inferred Primary Effectiveness Endpoint) | Reported Device Performance (100Hz Cellulite Dose Study) |
|---|---|
| Blinded independent physician assessment (IPA) panel correctly identifies post-treatment 50 Hz dose and 100 Hz dose photographs. | 100% correct identification for both 50 Hz and 100 Hz treatment doses. |
| No significant difference between the 50 Hz and 100 Hz doses in the Wilcoxon matched pairs signed rank test. | "No significant difference" found between the two doses in the Wilcoxon matched pairs signed rank test. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 15 female participants.
- Data Provenance: The document does not explicitly state the country of origin. It indicates a "bridging study was performed," implying a prospective study. Participants were treated with the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: The document refers to a "blinded independent physician assessment (IPA) panel." The specific number of physicians on this panel is not provided.
- Qualifications of Experts: Only "physician" is mentioned; no specific qualifications (e.g., specialization, years of experience) are detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The adjudication method is described as "Correct ID (2 of 3)" in Table 6-2 for the Cellulite Dose Study. This suggests that a decision was considered "correct" if at least two out of three adjudicators agreed.
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
- No MRMC comparative effectiveness study was done. This study compared two treatment settings (50Hz vs. 100Hz) of the same device on patients, with physicians assessing the outcomes after treatment, not with AI assistance. Therefore, there is no information on human reader improvement with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a physical medical device (acoustic pulse device) and not an AI algorithm. The "performance data" section focuses on hardware safety, software verification, and clinical study outcomes, not an AI algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: Expert consensus based on "blinded independent physician assessment (IPA)" of before and after photographs of patients. Outcomes data (long-term improvement in cellulite appearance) from previous studies also informed the context.
8. The sample size for the training set
- The document describes a clinical study to compare two treatment settings (50Hz vs. 100Hz) of the device. It does not mention a "training set" in the context of machine learning. The device itself is not described as an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a machine learning training set for this device.
§ 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.