(70 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.
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.
The provided text describes the SofWave System, a focused ultrasound stimulator system for aesthetic use. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SofWave System, K223237) for the addition of a smaller applicator.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format as commonly seen for diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the substantial equivalence is based on demonstrating similar technological characteristics, safety, and effectiveness to its predicate. The key performance criteria evaluated relate to the functional equivalence of the new small applicator to the existing large applicator regarding thermal effects.
| Acceptance Criteria (Inferred from study description) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993 standards for patient-contacting components. | Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993. |
| Software Performance: Software verification and validation demonstrate intended performance. | Software verification and validation was performed, and demonstrated that the software performs as intended. |
| Electrical Safety & EMC: Compliance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, and IEC 60601-2-62. | Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, and IEC 60601-2-62. |
| Functional Bench Testing: Addition of small applicator does not affect device performance. | Functional bench testing was conducted to verify that the addition of the small applicator did not affect the device performance. |
| In Vivo Thermal Effects: Small applicator produces substantially equivalent histological tissue thermal effects and coagulative zones as the larger applicator of the predicate device across a range of treatment settings. | The preclinical, acute, in vivo study using a porcine model demonstrated that the new small applicator has substantially equivalent thermal effect to the larger applicator of the previously cleared SofWave System (K223237) as assessed by histopathology evaluation of coagulation areas. Specific quantitative metrics (e.g., size or depth of coagulation zones) are not provided in this summary, but the conclusion states "substantially equivalent thermal effect." |
Study Details:
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Test Set Sample Size and Data Provenance:
- Sample Size: The document mentions "an animal model" (porcine model) for the in vivo study. It doesn't specify the number of animals or the number of tissue samples / treatment areas evaluated.
- Provenance: Preclinical, acute, in vivo study using a porcine model. Country of origin is not specified.
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Number of Experts and Qualifications for Ground Truth:
- Number of Experts: "a third-party expert reviewer" (singular).
- Qualifications: Not explicitly stated beyond "third-party expert reviewer."
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Adjudication Method for Test Set:
- The document states, "Histopathology evaluation of coagulation areas was performed by a third-party expert reviewer blinded to the treatment setting." This indicates a single blinded reviewer, so no multi-reader adjudication method (e.g., 2+1, 3+1) was used.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is an aesthetic treatment device, and the study presented focuses on its biophysical effects (thermal coagulation) rather than diagnostic performance requiring human interpretation with and without AI assistance.
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Standalone Performance (Algorithm only without human-in-the-loop):
- This question is not directly applicable in the context of this device. The SofWave System is a physical medical device (ultrasound stimulator), not an AI algorithm. The performance evaluated relates to the physical effects of the device itself. The software controls the device operation, and its performance was verified as part of functional checks, but there's no "standalone algorithm performance" in the traditional sense of an AI diagnostic.
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Type of Ground Truth Used:
- The ground truth for the in vivo study was "histopathology evaluation of coagulation areas" by a third-party expert.
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Training Set Sample Size:
- The document discusses a preclinical in vivo study to evaluate the new small applicator, but it does not describe a "training set" in the context of an algorithm's development. The study is a verification/validation study for the device's physical effects.
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How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no mention of a training set for an algorithm. The in vivo study served as a performance evaluation, not a training phase for 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.