(87 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 intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
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 Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.
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) the console; 2) the applicator; and 3) 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 FDA 510(k) clearance letter and summary for the SofWave System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, particularly in relation to AI/software performance.
The document details the device's technological characteristics, comparison to predicate devices, and regulatory compliance (electrical safety, EMC, software V&V). However, it explicitly states under "Clinical Summary": "No clinical test data was required to support substantial equivalence." This means there was no clinical performance study conducted to demonstrate the device's effectiveness in achieving its stated indications (e.g., improvement of facial lines, muscle tone) through a study with human subjects, let alone one involving AI assistance or a standalone AI algorithm.
Therefore, many of the requested points cannot be extracted from this document because the type of study you are asking about (a performance study with acceptance criteria, human readers, ground truth establishment, etc.) was not performed or submitted for this 510(k) clearance.
Below, I will fill in the requested table and answer the questions based only on the information available in the provided text. Where information is not present, it will be explicitly stated.
Acceptance Criteria and Device Performance Study (Based on Provided Document)
Summary: The provided FDA 510(k) clearance document for the SofWave System demonstrates substantial equivalence through comparisons to predicate devices and non-clinical performance testing (software verification and validation, electrical safety, functional bench testing), but explicitly states that no clinical test data was required. Therefore, a clinical study with acceptance criteria related to device efficacy (e.g., improvement in facial lines, muscle tone) and involving a test set, expert ground truth, or AI performance metrics was not conducted and is not described in this document.
1. Table of Acceptance Criteria and Reported Device Performance
Given that "No clinical test data was required to support substantial equivalence," the document does not present clinical acceptance criteria for efficacy or performance in the way one might expect for a diagnostic AI device. The acceptance criteria mentioned are related to non-clinical performance and regulatory compliance.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit from Text) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Software Performance | Software performs as intended. (Implied acceptance via "Software verification and validation was performed") | "Software verification and validation was performed, and demonstrated that the software performs as intended" |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-10 (and others per various tables). Meeting specified leakage currents. | "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"; "Normal condition = less than 100µA" (for patient leakage current) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | "Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2," (among others) |
| Functional Bench Testing | Minor device modifications do not affect device performance. (Implied acceptance via "Functional bench testing was conducted to verify") | "Functional bench testing was conducted to verify the minor device modifications did not affect the device performance." (and "In all instances, the subject SofWave System performed as intended.") |
| Substantial Equivalence | Device is as safe and effective as its predicate device, showing similar intended use, indications, technological characteristics, and principles of operation, with minor differences not raising new safety/effectiveness questions. | "Thus, the SofWave is substantially equivalent to its predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided. The document explicitly states, "No clinical test data was required." The functional and software testing conducted would not typically involve a "test set" in the context of patient data or clinical outcomes.
- Data Provenance: Not applicable / Not provided. No patient data or clinical data is mentioned as being used for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. Since no clinical test data was required, there was no need for experts to establish ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set or ground truth adjudication took place.
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
- Not applicable / Not provided. No clinical study, MRMC study, or AI assistance component (in the clinical efficacy sense) is detailed or claimed in this 510(k) summary. The "Pure Impact module" section describes the device as a "Powered Muscle Stimulator" and refers to "muscle training" but does not indicate any AI-driven diagnostic or interpretative capabilities that would necessitate an MRMC study for improved human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. The device described is a medical system with specific treatment functionalities (ultrasound for aesthetic treatments, EMS for muscle stimulation). It is not described as an AI algorithm intended for standalone diagnostic or evaluative performance. Software verification and validation were performed, but not in the context of an AI algorithm's standalone performance against a clinical ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided for clinical efficacy. The "ground truth" for the non-clinical testing would be the engineering specifications and established standards (e.g., IEC standards for electrical safety), which the device was verified against.
8. The sample size for the training set
- Not applicable / Not provided. If there were any machine learning components, details about a training set are not included in this 510(k) summary, as it explicitly states "No clinical test data was required."
9. How the ground truth for the training set was established
- Not applicable / Not provided. (See point 8).
Conclusion: The provided FDA 510(k) clearance document for the SofWave System focuses on demonstrating substantial equivalence to predicate devices and fulfilling non-clinical performance and safety requirements. It explicitly states that clinical test data was not required for this clearance. Therefore, the detailed information about acceptance criteria for clinical performance, test set characteristics, expert ground truth establishment, or AI performance studies (MRMC, standalone) that you requested are not present in this document.
§ 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).