(118 days)
The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
The sensiLift is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:
- . User Interface
- Programmable logic controller (PLC, microcontroller) embedded in PCBA ●
- RF power module
- Power Supply ●
- RF electrodes ●
The provided document describes the SensiLift device, an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles. The document outlines the studies conducted to demonstrate its safety and effectiveness for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SensiLift device are inferred from the safety and effectiveness endpoints of the clinical study, as well as the successful completion of various non-clinical bench tests and human factors studies.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from study objectives) | Reported Device Performance |
|---|---|---|
| Safety | - No adverse events | No adverse events occurred during and after the study. |
| - RF delivery deactivates when skin temperature exceeds 40°C | Two redundant thermistors continuously monitored skin temperature and automatically de-activated RF energy delivery when temperature of 40°C/104°F was detected. | |
| - Power accuracy within error margin | Measured total power was within the error margin. | |
| - Compliance with electrical safety and EMC standards (IEC 60601 family) | The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-2. | |
| - Software verification and validation (for "moderate" level of concern) | Software verification and validation testing were conducted as recommended by FDA guidance, with a "moderate" level of concern. | |
| - Biocompatibility of body contact materials | All body contact materials are biocompatible per ISO 10993-5:2009 and ISO 10993-10:2010. | |
| Effectiveness | - Improvement in overall facial wrinkles appearance (at least one score decrease on Fitzpatrick Wrinkles Severity Scale) at end of active treatment (T8) | 89%, 95%, and 95% of participants (as assessed by 3 reviewers, respectively) showed improvement. |
| - Improvement in overall facial wrinkles appearance at 3 months after last treatment (FU2) | 97%, 100%, and 100% of participants (as assessed by 3 reviewers, respectively) showed improvement. | |
| - High user satisfaction | All participants were highly satisfied, with 89% reporting improvement in their skin's appearance. Average satisfaction: 1.66 ± 0.25 on a 1-5 discrete scale (1=best). | |
| Human Factors/Usability | - User comprehension of labeling and ability for self-selection | 100% of participants reported correct answers regarding intended use, treatment areas, and contraindications. |
| - OTC user can correctly use the device based on labeling | All tasks were completed by 100% of participants, with a 100% success rate per task scenario. |
Study Details
The document primarily describes a single-arm, prospective, interventional clinical study for effectiveness and safety, along with several non-clinical studies.
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A table of acceptance criteria and the reported device performance: See table above.
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Sample sizes used for the test set and the data provenance:
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Clinical Study (Effectiveness & Safety):
- Enrollment: 40 female participants (ages 40-64).
- Completed Study: 35 participants (total of 87 treatment areas) completed 8 treatments and the 3-month follow-up.
- Provenance: Not explicitly stated, but presumable from the location of the submitting company (Israel) or where a clinical trial would be conducted. The study is described as "prospective" and "interventional."
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Human Factors Validation Testing:
- Labeling Comprehension/Self-Selection Study: 43 participants (2 men, 41 women), ages 18-65 (45 ± 13 years old).
- Usability/User Interface Study: Not explicitly stated but implies a subset of the 43 participants or a similar number based on "14 out of 20" and "7 out of 20" comments. Assuming it's at least 20 participants for this part.
- Provenance: Not specified, but likely conducted in a simulated environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Study (Effectiveness): 3 independent physicians (apart from the PI - Principal Investigator).
- Qualifications: "3 board certified dermatologists or plastic surgeons."
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Adjudication method for the test set:
- Clinical Study (Effectiveness): Wrinkles appearance was assessed independently by the 3 physicians. There is no explicit mention of an adjudication process (e.g., 2+1 or 3+1 consensus). The percentages of improvement are reported for each reviewer separately (e.g., "89%, 95% and 95% of the study participants (as assessed by 3 reviewers, respectively)"). This implies independent assessment rather than a combined adjudicated score for each participant.
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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 MRMC comparative effectiveness study involving AI assistance for human readers was conducted or described. This device is a direct-to-consumer physical device for wrinkle treatment, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical electrosurgical aesthetic device, not an algorithm. Bench tests and a clinical trial evaluated the device's standalone performance in a human-in-the-loop setting (users operating the device).
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The type of ground truth used:
- Clinical Study (Effectiveness): Expert assessment using the Fitzpatrick Wrinkles Severity Scale. Improvement was defined as a decrease of at least one score on this scale. This is a clinical outcome observed by qualified experts.
- Clinical Study (Safety): Observation of adverse events.
- Human Factors Study: Direct observation of task completion and user responses to questions.
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The sample size for the training set:
- The document implies that the clinical study was conducted for final validation and performance assessment. There's no separate mention of a distinct "training set" for an algorithm, as this is a physical device submission. If the device's software had any machine learning components, details about a training set would typically be provided under software V&V. The software concern level is "moderate," indicating potential harm from errors, but it's not described as an AI/ML algorithm.
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How the ground truth for the training set was established:
- Not applicable, as a discrete training set for an AI/ML algorithm is not described. The clinical study acts as the primary validation of the device's performance against ground truth established by expert consensus (dermatologists/plastic surgeons) using a recognized severity scale.
§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.
(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.