(87 days)
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; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
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, loT, 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 provided text describes the acceptance criteria and a clinical study conducted to expand the indications for use of the SofWave System to include improvement of the appearance of skin laxity on the upper arms.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Improvement in upper arm skin laxity | 93% of treated arms showed improvement as assessed by blinded reviewers. |
| Safety profile/device-related adverse events | No device-related adverse events. |
| Patient discomfort/pain | Most subjects reported none to mild levels of pain during treatment and no discomfort afterward. |
2. Sample size used for the test set and the data provenance
- Sample Size: 46 subjects.
- Data Provenance: Prospective, self-controlled, multicenter study conducted at 4 sites in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: 3 blinded reviewers.
- Qualifications of experts: The document does not explicitly state the qualifications of the "blinded reviewers" (e.g., dermatologists, plastic surgeons, specific years of experience). It only states they were "blinded reviewers."
4. Adjudication method for the test set
- Adjudication method: The primary efficacy evaluation was based on the "correct identification of the pre- and post-treatment photographs by at least 2 of 3 blinded reviewers." This implies a form of 2 out of 3 consensus or majority vote.
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
- MRMC Comparative Effectiveness Study: No, this was not an MRMC comparative effectiveness study involving AI assistance for human readers. The study described is a clinical trial evaluating the effectiveness of the SofWave System itself, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone (algorithm only) performance: No, this device is a physical medical device (ultrasound system) for aesthetic treatment, not an AI algorithm. The performance described is the outcome on patients.
7. The type of ground truth used
- Type of ground truth: Expert assessment/consensus. The primary efficacy was determined by the assessment of pre- and post-treatment photographs by blinded reviewers, and secondary efficacy endpoints were also assessed by these reviewers using a grading scale. Subjective reports of pain and discomfort were also used.
8. The sample size for the training set
- Sample size for training set: This information is not applicable or provided. The study described is a clinical trial for a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: This information is not applicable or provided because it's not an AI model.
§ 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.