(122 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 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 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, IoT, 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 subject device of this 510(k) adds an EMS module ("Pure Impact") to the previously cleared SofWave ultrasound system (K230820). The EMS module is wirelessly connected to and controlled by the SoftWave console. It functions independently from the existing 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 describes the SofWave System, specifically focusing on the addition of an EMS module called "Pure Impact." The document is a 510(k) summary from the FDA, outlining the substantial equivalence of the SofWave System to predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria beyond general statements about nonclinical performance testing and substantial equivalence. It primarily focuses on comparing the technological characteristics of the new Pure Impact module with existing predicate and reference devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts, their qualifications, or adjudication method for ground truth.
- MRMC study information or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance Data" section (page 12) only lists high-level nonclinical tests that were conducted:
- Biocompatibility (ISO 10993-1)
- Software verification and validation
- Electrical Safety and Electromagnetic Compatibility (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, IEC 60601-2-62, and IEC 62133)
- Functional bench testing
- Usability validation study
For these tests, it simply states that the "SofWave System functioned as intended" and "demonstrated that the device performs as intended." No specific metrics, acceptance thresholds, or study results are provided. The document concludes with a statement that "The minor technological differences between the subject and the predicate devices do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus is substantially equivalent to its predicates."
Without further documentation, it's impossible to detail the acceptance criteria and the study that proves the device meets them as requested.
§ 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.