(236 days)
The InMode WMface device is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytides.
The InMode WMface device is designed to deliver radio frequency (RF) energy which is emitted into the skin in a uniform manner, via two pairs of bi-polar electrodes. RF energy heats the tissue to trigger collagen remodeling for the treatment of wrinkles and rhytides. The InMode WMface device is designed to deliver RF energy to the skin. The device provides individual adjustment of RF power to achieve maximum efficiency and safety for each patient. The ergonomic hand piece allows efficient treatment of the skin. The InMode WMface device consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a handle and two pairs of electrodes.
The InMode WMface Device is an electrosurgical cutting and coagulation device intended for noninvasive treatment of mild to moderate facial wrinkles and rhytides.
Here's an analysis of its acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Output Parameters | RF Output Power | 10-65 Watt (Matches predicate device) |
| RF Output Frequency | 1 MHz ± 2% (Matches predicate device) | |
| Skin Temperature Maintenance | Consistently maintained below specified temperature limit during recommended treatment. | |
| Thermal Energy Distribution | Identical energy distribution pattern | Demonstrated identical pattern to predicate device in ex-vivo tests. |
| Penetration depth | Demonstrated identical penetration depth to predicate device in ex-vivo tests. | |
| Maximal temperature | Demonstrated identical maximal temperature to predicate device in ex-vivo tests. | |
| Safety | Compliance with IEC 60601-1, IEC 60601-1-2 | Complies with these standards. |
| Compliance with IEC 60601-2-2 | Complies with this standard. | |
| Biocompatibility | Materials in contact with skin | All device materials in contact with skin surface are biocompatible. |
| Cleaning | Device is intended for multiple use and must be cleaned | Cleaning instructions are provided in the Instruction For Use. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not applicable. The primary studies described are bench tests and ex-vivo tests, not clinical studies with human participants.
- Data Provenance: The bench tests and ex-vivo tests were likely conducted in a controlled laboratory environment. The document does not specify a country of origin for the data but the applicant is based in Israel. The studies are not described as retrospective or prospective clinical trials.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The reported studies are non-clinical (bench and ex-vivo) and do not involve expert assessment of clinical outcomes or images for establishing ground truth. Ground truth for these tests would be based on instrument readings and physical measurements.
4. Adjudication Method for Test Set:
Not applicable, as no human-reviewed test set is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission relies on non-clinical performance data (bench and ex-vivo tests) to demonstrate substantial equivalence to a predicate device, rather than comparative clinical efficacy against human readers or other devices.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
Yes, the studies conducted were standalone. The device's performance was evaluated independently in bench tests and ex-vivo tests. There is no mention of a human-in-the-loop component in these studies.
7. Type of Ground Truth Used:
The ground truth for the non-clinical studies was based on:
- Instrumental Measurements: For RF output power, frequency, and skin temperature.
- Physical Observations/Measurements: For thermal energy distribution, penetration depth, and maximal temperature in the ex-vivo porcine tissue model.
8. Sample Size for Training Set:
Not applicable, as this is a medical device and not an AI/algorithm-based diagnostic or imaging device that would typically have a training set for machine learning. The "training" of the device is through its engineering design and manufacturing to meet specified parameters.
9. How Ground Truth for Training Set Was Established:
Not applicable for the reasons stated in point 8.
§ 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.