(58 days)
The Softem is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SoftWave System is also intended for short-term improvement in the appearance of cellulite.
The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console.
The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; and for short-term improvement in the appearance of cellulite.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|
| Improvement in cellulite appearance (as assessed by blinded independent reviewers) | Blinded reviewers correctly identified post-treatment images for 89% of subjects. |
| Safety of the device | Only one adverse event reported, unrelated to the device. No serious or unanticipated adverse events. Mean pain level was 4.6 (moderate). |
| Consistency with predicate device in terms of clinical effects for cellulite | Study results were consistent with predicate device based on a literature review. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 68 subjects were treated.
- Data Provenance: Prospective clinical study conducted at 4 sites in the United States.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Unspecified number of "blinded independent reviewers."
- Qualifications: "Blindness" implies they were unaware of the treatment status of the images. Specific professional qualifications (e.g., dermatologists, plastic surgeons, radiologists) are not provided in this document.
4. Adjudication Method for the Test Set
- The document states that "blinded independent reviewers" assessed photographs. It does not specify a formal adjudication method like "2+1" or "3+1" for discrepancies, implying either a single reviewer per assessment or a consensus approach without explicit detailing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly mentioned or detailed in this document regarding human readers improving with or without AI assistance. The study focused on the device's standalone effectiveness.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone study demonstrating the algorithm's performance (the device in this case, as it's a treatment system) was conducted. The clinical study evaluated the device's ability to improve cellulite appearance without human intervention beyond performing the treatment and assessing results.
7. Type of Ground Truth Used
- For Cellulite Improvement: Expert consensus/review of clinical photographs using the Cellulite Severity Scale (CSS) and Global Aesthetic Improvement Scale (GAIS), and Laxity Scale (LS) for blinded independent reviewers.
8. Sample Size for the Training Set
- The document does not detail a separate training set for an AI/algorithm in the traditional sense, as the device is a therapeutic system rather than a diagnostic AI. The "performance data" section focuses on the clinical study for expanding indications, which acts as the primary evidence for its effectiveness for the specified condition.
9. How Ground Truth for the Training Set Was Established
- Not applicable as there is no mention of a separate training set for an AI algorithm. The device's "training" and validation in a broader sense would be through its engineering and design processes, and its clinical performance is assessed through the described study.
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.