(57 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.
· Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
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 three main functional components: 1) console: 2) applicator: and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes 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.
This FDA 510(k) K241685 summary describes the SofWave System, which includes an ultrasound system and an Electrical Muscle Stimulation (EMS) module (Pure Impact). The 510(k) submission is for minor changes to the existing SofWave System (K240687) and an updated software for the Pure Impact module to include the arms in its indications for use.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for performance in a quantitative sense for this 510(k) submission. Instead, it focuses on demonstrating substantial equivalence to predicate devices for the modified SofWave system and the Pure Impact module. The performance data section primarily discusses validation of the changes.
However, based on the context of a 510(k) and the information provided, we can infer the acceptance criteria were that the device performs as intended and that the changes do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|
| Minor changes in SofWave module do not raise different questions of safety or effectiveness. | "Performance testing, including design verification testing and electrical safety testing, confirmed the minor changes in the SofWave module did not raise different questions." |
| Software modifications for Pure Impact module are successfully implemented without major issues. | "The software modifications were evaluated through software verification testing, which was completed successfully with no major issues found." |
| Overall, the device performs as intended. | "In all instances, the subject SoftWave System performed as intended." |
| Pure Impact module has similar output waveform specifications as predicate/reference devices. | "Notably, the subject Pure Impact module has very similar output waveform specifications as the accufit predicate device and the HIVOX reference device. As shown in the detailed comparison below, all parameters are similar between the devices. Differences are minor and not clinically relevant." (Detailed table 3 on pages 9-10 supports this.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
This indicates that there was no clinical test set in the traditional sense for evaluating the device's clinical performance against an acceptance criterion in this particular 510(k) submission. The evaluation focused on engineering and software verification and validation. Therefore, information about sample size and data provenance for a "test set" in the context of clinical performance is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
Since "No clinical test data was used," there was no "ground truth" establishment by experts in the context of a clinical test set. The evaluation was based on engineering and software testing against predefined specifications and comparisons to predicate devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test data was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "No clinical test data was used."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described is a physical medical device (ultrasound system and electrical muscle stimulator) with software components, not an AI/algorithm-only device. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to AI medical devices is not applicable. The software modifications were validated through software verification testing.
7. The Type of Ground Truth Used:
For the evaluation described in this summary, the "ground truth" for demonstrating substantial equivalence was effectively:
- Engineering specifications and standards: The device's electrical safety, design, and waveform output (for the Pure Impact module) were compared against established engineering principles and relevant voluntary standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971).
- Predicate device characteristics: The technological characteristics and performance of the modified SofWave module and the Pure Impact module were compared directly to already cleared predicate devices (K240687 for SofWave module and Pure Impact, and K233926 for accufit as another EMS predicate). The "ground truth" was that the subject device's performance fell within acceptable ranges or was equivalent to these legally marketed devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that involves a "training set" in the conventional sense. The software modifications mentioned were validated through verification testing, not a machine learning training process.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set was used.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).