(79 days)
The SofMave 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 region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.
The Pure Impact module is indicated to be used for:
· Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
· Strengthening, toning and firming of buttocks and thighs.
The SofMave 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 SofMave System consists of three main functional components: 1) console; 2) applicator; and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz 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 EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.
The provided text focuses on the 510(k) submission for the SofWave System, specifically for the addition of a "Smooth applicator" and its use in "short-term improvement in the appearance of cellulite." The core of the submission is to demonstrate substantial equivalence to a predicate device (K232455), which fundamentally relies on showing that the changes introduced (the Smooth applicator) do not raise new questions of safety or effectiveness.
It is important to note that the provided text does not detail specific, quantified acceptance criteria for the device's performance in terms of achieving a certain level of improvement in cellulite appearance, nor does it present a direct comparative effectiveness study (MRMC) against human readers or specify an "effect size of how much human readers improve with AI vs without AI assistance." This is because the device itself is a treatment device (Focused Ultrasound Stimulator System for Aesthetic Use), not an AI-based diagnostic tool that assists human readers.
Instead, the "performance data" section describes the studies conducted to demonstrate that the device (with the new applicator) functions safely and as expected, aligning with the predicate device's established performance. The study described is a clinical study for safety and effectiveness related to cellulite appearance, which is a clinical outcome rather than an algorithm's performance in a diagnostic task.
Given this context, I will extract and present the information as best as possible, interpreting "acceptance criteria" and "device performance" in the context of a treatment device demonstrating substantial equivalence, rather than a diagnostic AI.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a treatment device, the "acceptance criteria" are implied by the FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" (2011) and the expectation of demonstrating substantial equivalence to a predicate device. The performance is assessed in terms of safety and the expected aesthetic improvement, similar to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device-related adverse events are minimal and mild. | Throughout the study, there was only one device-related adverse event reported, which was mild in severity. No serious or unanticipated adverse event was reported during the study. |
| Effectiveness (Cellulite Appearance): Demonstrates improvement in cellulite appearance, consistent with predicate device. | Blinded Reviewer Assessment: The blinded reviewers correctly identified the post-treatment images for 92% of the subjects. |
| Pain Level: The mean pain level was 4.26 (moderate pain). No subjects withdrew from the study due to discomfort or pain. | |
| Consistency with Predicate: Based on a literature review, the study results were consistent with the predicate device. | |
| Functional Bench Testing: Addition of Smooth applicator does not negatively affect device performance. | Functional bench testing was conducted to verify that the addition of the Smooth applicator did not affect the device performance (reported as "demonstrated that the device performs as intended"). Acoustic mapping testing showed very similar acoustic parameters for the Smooth and Lift applicators. Thermal coagulation for each PZT is expected to be the same, demonstrated in performance testing. |
| Biocompatibility: Patient-contacting components are biocompatible. | Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993. |
| Software Verification and Validation: Software performs as intended. | Software verification and validation was performed, and demonstrated that the software performs as intended. |
| Electrical Safety and EMC: Complies with relevant standards. | Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, and IEC 60601-2-62. |
| In vivo (Animal) Safety & Effectiveness: Thermal effects and coagulation zones are as expected. | The preclinical, acute, in vivo study using a porcine model demonstrated that the thermal effects and the coagulation zones induced by SofWave Smooth applicator are as expected. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 60 subjects were enrolled and treated in the clinical study.
- Data Provenance:
- Country of Origin: The clinical study was conducted at 5 sites in the United States.
- Retrospective or Prospective: The clinical study for cellulite appearance was prospective, as subjects received treatments and were followed up (baseline, 3-month follow-up). The animal model study was also prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text describes that "blinded independent reviewers" assessed photographs to identify pre-treatment vs. post-treatment images and grade improvement.
- Number of experts: Not specified explicitly. It states "blinded independent reviewers" (plural).
- Qualifications of experts: Not specified beyond being "independent" and "blinded." Their specific medical or aesthetic qualifications (e.g., dermatologists, plastic surgeons, radiologists) are not detailed.
4. Adjudication method for the test set
The text does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for the "blinded independent reviewers'" assessments. It just states they "assessed" and "correctly identified" images, implying a single assessment per reviewer or the aggregate result of their assessments.
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 Study: No, an MRMC comparative effectiveness study was not conducted in the traditional sense of evaluating an AI's impact on human reader diagnostic performance. The SofWave System is a treatment device, not a diagnostic AI. The clinical study aimed to demonstrate the device's safety and effectiveness in treating cellulite, not to improve human diagnostic accuracy.
- Effect Size of Human Readers with/without AI: Not applicable for this device and study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable/not performed in the context of an AI algorithm's diagnostic performance. The "device performance" was evaluated in terms of its physical outputs (acoustic parameters, thermal effects) and its clinical outcomes when used by an operator (as a therapy).
7. The type of ground truth used
The "ground truth" for the clinical study on cellulite improvement was established through:
- Expert Consensus/Blinded Reviewer Assessment: Serial clinical photographs assessed by blinded independent reviewers to identify pre-treatment vs. post-treatment images and grade improvement using established scales (Cellulite Severity Scale - CSS, Global Aesthetic Improvement Scale - GAIS, Laxity Scale - LS). This is a form of expert consensus on photographic evidence.
- Outcomes Data: Evaluation of Adverse Events (AEs) via physician examination.
- Pathology/Histology (for animal study): For the animal model, the ground truth for the efficacy of the thermal effects was histological tissue thermal effects and coagulative zones.
8. The sample size for the training set
The text relates to a 510(k) submission for a physical medical device (ultrasound system), not for an AI algorithm that requires a "training set" in the machine learning sense. Therefore, a sample size for a training set is not applicable and not mentioned.
9. How the ground truth for the training set was established
As explained above, there is no "training set" in the context of an AI algorithm here. The ground truth for the device's development and validation involved engineering specifications, bench testing, animal studies, and limited human clinical data to demonstrate physical and clinical performance, but not in the format of a machine learning training dataset.
§ 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.