(187 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 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.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Indication/Endpoint | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Eyebrow Lift | ||
| % Blinded Reviewer Identification of Pre- vs. Post-Treatment (Eyebrow) | Implicitly, significant identification rate demonstrating improvement | 79% (53/67) identified correctly |
| Objective Measurement of Maximal Eyebrow Height (MEH) | Implicitly, measurable average lift | 0.78 mm average lift |
| Objective Measurement of Average Eyebrow Height (AEH) | Implicitly, measurable average lift | 0.69 mm average lift |
| PGAIS Assessment (% Improved) | Implicitly, significant improvement rate | 80% (51/64) improved at 3-month follow-up |
| Patient Satisfaction (Eyebrow Lift) | Not explicitly defined as an acceptance criterion, but reported for context | 55% reported improvement and satisfaction |
| Lax Submental and Neck Tissue Lift | ||
| % Blinded Reviewer Identification of Pre- vs. Post-Treatment (Submental/Neck) | Implicitly, significant identification rate demonstrating improvement | 80% (60/75) identified correctly |
| Objective Measurement of Lax Submental and Neck Tissue Lift (Area) | Implicitly, measurable average lift | 38 mm² average lift |
| PGAIS Assessment (% Improved) | Implicitly, significant improvement rate | 85% (61/72) improved at 3-month follow-up |
| Patient Satisfaction (Submental/Neck Lift) | Not explicitly defined as an acceptance criterion, but reported for context | 55% reported improvement, 50% reported satisfaction |
Note: The document does not explicitly state numerical acceptance criteria for each endpoint. Instead, it reports the performance and states that "both co-primary endpoints are met," implying that the observed performance was considered sufficient for approval.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set):
- 92 subjects enrolled.
- 80 subjects treated.
- 467 facial areas treated across 3 zones.
- Specific numbers for each endpoint:
- Eyebrow Lift (Zone 1): 67 subjects evaluated for blinded review, 64 for PGAIS and patient satisfaction.
- Submental/Neck Lift (Zone 3): 75 subjects evaluated for blinded review, 72 for PGAIS and patient satisfaction.
- Data Provenance: Prospective, conducted at 5 investigational sites in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The text mentions "independent masked evaluators" and "blinded reviewers" for both eyebrow lift and submental/neck lift.
- Number of Experts: Two blinded reviewers are explicitly mentioned for identifying pre- vs. post-treatment images for both eyebrow and submental/neck lift (e.g., "based on the agreement of two blinded reviewers").
- Qualifications of Experts: Not specified in the provided text.
4. Adjudication Method for the Test Set
- For the co-primary effectiveness endpoints related to image identification, the results are "based on the agreement of two blinded reviewers." This implies a form of consensus or 2-reader agreement was used. The specific rule (e.g., unanimous, majority) is not detailed.
- For other assessments like PGAIS, it's "Physician Global Aesthetic Improvement Scale (PGAIS) assessment," suggesting physician evaluation, but no explicit adjudication method is stated for individual physician assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to compare human readers with and without AI assistance for this device.
- The study was designed to evaluate the standalone performance of the SofWave System for aesthetic improvements.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, this device is a medical system that requires human operation. The performance described is the device's effectiveness when used on patients, not an AI algorithm's standalone performance. The "device performance" mentioned in the non-clinical section refers to functional bench testing of the system itself, not its output as an algorithm.
7. Type of Ground Truth Used
- Clinical Ground Truth: The ground truth was established through a combination of:
- Expert Clinical Assessment: "Independent masked evaluators'" correction identification of pre-post image sequence and "Physician Global Aesthetic Improvement Scale (PGAIS) assessment."
- Objective Quantitative Measurement: Objective measurements of maximal eyebrow height (MEH), average eyebrow height (AEH), and lax submental and neck tissue lift (area) using "quantitative 2D imaging."
- Patient Reported Outcomes: Patient satisfaction questionnaires.
8. Sample Size for the Training Set
- The document does not specify a training set size. The clinical study described appears to be for "expansion of indications" and serves as the primary effectiveness and safety evaluation reported here, consistent with a pivotal study for premarket notification. This device is a physical system, not an AI algorithm requiring a specific data "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as the document does not describe an AI algorithm that would typically require a "training set" with established ground truth in the conventional sense. The "ground truth" discussed in the performance data section refers to the clinical outcomes observed in the human subjects treated with the device.
§ 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.