(134 days)
The sensiFirm device is intended for the following medical conditions using non thermal RF combined with massage:
Temporary reduction in the appearance of cellulite.
The sensiFirm is an OTC, home use device, designed to deliver non-thermal RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the non-thermal RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a noninvasive, non-ablative device and it is supplied as non-sterile.
The sensiFirm device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes a vibration motor, four Bi-polar (2 pairs) electrodes and two redundant temperature sensors. The PLC (on the PCBA) is specially configured software combined with hardware circuits that provides the operational and safety function of the system.
The sensiFirm device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the non-thermal RF energy together with mechanical massage over the entire treatment area.
The document describes the acceptance criteria and the study that proves the device, sensiFirm, meets these criteria for the temporary reduction in the appearance of cellulite.
Here’s the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety - Skin Temperature | Max skin temperature of 41°C / 105.8°F (or below pain threshold of 44°C and burn threshold of 48°C) | RF delivery automatically stops when skin temperature exceeds 41°C, resuming at 40.5°C. No adverse events occurred during and after the clinical study. |
| Safety - Electrical/Mechanical | Compliance with IEC 60601 family of standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-2). | Bench testing conducted and device complies with all listed standards. |
| Safety - Software | Software verification and validation per FDA guidance. | Software verification and validation testing conducted and documentation provided, classified as "moderate" level of concern. |
| Safety - Human Factors (Label Comprehension) | Typical OTC users can understand device labeling and correctly choose the device for its intended use and self-selection (contraindications). Primary endpoint: 100% correct decision regarding intended use, 98% correct for treatment areas, 96% correct for contraindications. | 100% of participants made correct decision regarding intended use, 98% correctly identified treatment areas, and 96% reported correct answers for contraindications (K=0.91). Success criteria for primary endpoint met. |
| Safety - Human Factors (Usability/User Interface) | Intended OTC user can correctly use the device based on labeling materials for aesthetic purpose. Primary endpoint: 100% success rate per each task scenario. | All 21 tasks across four use scenarios were completed by 100% of participants, with a 100% success rate per each task scenario. Success criteria for primary endpoint met. |
| Effectiveness - Cellulite Appearance (Evaluator Assessment) | At least 2 out of 3 independent evaluators agree on at least one degree of improvement (score reduction) in the Modified Neurenberg-Muller Cellulite Grading Scale compared to baseline. | At T8 (end of active treatment): 93% of participants showed improvement. |
| At FU1 (1 month post-treatment): 96% showed improvement. | ||
| At FU2 (3 months post-treatment): 100% showed improvement. | ||
| Average reduction: -1.28 (T8), -1.59 (FU1), -1.78 (FU2). Untreated side remained unchanged. | ||
| Effectiveness - User Satisfaction | High user satisfaction with the device and improvement in skin appearance, cellulite appearance, and skin texture. | 95% of participants were generally satisfied. 94% reported improvement in skin's appearance, 89% in cellulite appearance and skin tightening, 90% in skin texture. Device found easy to use, comfortable to hold and reach treatment areas (82-93% agreement). 96% found the treatment regimen reasonable. All found it painless/discomfort-less. |
| Performance - Power Accuracy | Measured total power within predefined error margin on 150 Ω load and other impedance values. | The device met the acceptance criteria. |
| Performance - Parameter Validation | Varied parameters (radio frequency, pulse cycle, waveform, pulse duration) within acceptance criteria. | All results were within the acceptance criteria. |
| Biocompatibility | All parts in contact with user comply with ISO-10993-1, ISO 10993-5:2009 (cytotoxicity), and ISO 10993-10:2010 (sensitization and irritation). | Body contact materials are biocompatible per listed ISO standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study (Effectiveness):
- Sample Size: 33 women (age 29-63, average 46 ± 9 years).
- Data Provenance: Prospective, interventional, single-arm clinical study conducted in a home-use environment. Country of origin not explicitly stated but implied to be where the company is located (Israel) or a clinical site arranged by them.
- Human Factors Validation Testing (Usability/Label Comprehension):
- Labeling Comprehension/Self-Selection Study: 47 participants (5 men, 42 women, age 24-71, average 42 ± 12 years).
- Usability/User Interface Study: Not explicitly stated for this particular subsection, but it's part of the broader Human Factors testing which implies it leveraged the participants from the Human Factors study. (The document states "None of the participants required assistance from the moderator while performing the tasks," suggesting it refers to the same participant pool).
- Data Provenance: Not explicitly stated for Human Factors studies, but typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Clinical Study (Effectiveness):
- Number of Experts: 3 evaluators.
- Qualifications: 3 board-certified dermatologists and plastic surgeons.
4. Adjudication Method for the Test Set
- Clinical Study (Effectiveness):
- Adjudication Method: "A participant was considered a success if at least 2 out of the 3 independent evaluators agreed that the participant had shown at least one degree of improvement in the cellulite appearance." This is a form of 2-out-of-3 consensus or 2/3 agreement.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a single-arm clinical trial assessing the device's efficacy, with a comparison to an untreated control side of the body. There was no AI component to assist human readers described in this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The sensiFirm device is a physical device that delivers RF energy and massage; it is not an AI algorithm. Its performance is evaluated through its direct physical effects and user interaction, not as a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Clinical Study (Effectiveness): Expert consensus of 3 board-certified dermatologists and plastic surgeons using the Modified Neurenberg-Muller Cellulite Grading Scale, combined with participant satisfaction questionnaires (outcomes data). The design included "subject as her own control" and a concurrent untreated control side for objective comparison.
- Human Factors Validation Testing: Expert observation and qualitative assessment by a moderator for correct task completion and labeling comprehension, along with participant self-reporting/satisfaction.
8. The sample size for the training set
- This information is not provided in the document. The document describes a clinical study and human factors testing for device validation, not the development or training of an AI model.
9. How the ground truth for the training set was established
- Not applicable, as no AI model training is described in the provided document.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.