(111 days)
The EmFace Device with Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The EmFace Device with the Cheek and Chin Applicators is a hands-free, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 43℃. The hands-free applicators multiple RF units are sequentially activated over the treatment area. This ensures homogenous and safe heating distribution over the entire treatment area. The EmFace Device consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF non-invasive Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a Start/Stop button on the LCD screen. The System operates while connected to any of the following applicators: - . Chin Applicator (with three sequentially activated units) or; - . Cheek Applicator (with eight sequentially activated units) The applicator is connected to the main console via a designated cable and a connection port. The applicators' units are adjusted to the patient using an adjustable designated belt set.
The provided text describes the EmFace Device and its submission for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device (InMode PLUS System). The text focuses on safety and performance, rather than specific diagnostic accuracy or classification of medical conditions, which would typically involve detailed acceptance criteria for an AI-powered diagnostic device.
Therefore, many of the requested categories for AI device evaluation are not directly applicable or explicitly stated in the provided documentation, as the device is an electrosurgical cutting and coagulation device.
Here's an attempt to extract relevant information and note where the requested information is not available or applicable based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as pass/fail thresholds for specific clinical outcomes or diagnostic accuracy metrics. Instead, the "acceptance" is based on demonstrating safety and comparable performance to a predicate device, primarily through thermal effects.
| Acceptance Criteria (Implied from Safety/Performance Studies) | Reported Device Performance (EmFace Device) |
|---|---|
| Bench Testing (Temperature Build-up): | Similar temperature build-up to predicate device at 30W and 50W RF outputs. |
| - Similar heat transfer/loss characteristics | |
| - Temperature stability | |
| Pre-Clinical (Animal) Study (Thermal Effect): | |
| - No signs of tissue necrosis | No signs of tissue necrosis in porcine tissue in all power levels. |
| - Measured temperature on tissue surface ~43ºC | Measured temperature on tissue surface around 43ºC and lower in deeper tissue layers. |
| Clinical Performance (Human Study - Safety): | |
| - Safe use for intended purpose | Safe use demonstrated for temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. |
| - No adverse events reported | No adverse events reported. |
| - Desirable skin thermal profile (around 43ºC) | Skin thermal profile showed a desirable temperature level of around 43ºC. |
| - Tolerable discomfort levels | Most subjects endured maximal treatment parameters with mild to moderate discomfort. |
| - Comparable thermal outcomes to predicate device | Treatment methodology contributes to the same thermal outcomes obtained by using the respective predicate device for the same intended use. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size (Clinical Study): Thirty (30) eligible human subject participants.
- Data Provenance (Clinical Study): Prospective, conducted on human subjects (no specific country of origin mentioned, but the manufacturer is InMode MD Ltd. from Israel).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For aesthetic devices like this, "ground truth" related to diagnostic accuracy is not typically established by expert consensus in the same way it would be for an imaging-based AI diagnostic device. The "ground truth" here revolves around safety (e.g., absence of adverse events, temperature readings) and the observation of the device's intended physiological effects, likely performed by the study investigators.
4. Adjudication method for the test set
This information is not provided in the document. Given the nature of the device (electrosurgical for muscle relief, not a diagnostic tool), a formal adjudication process for "truth" in the context of diagnostic agreement (like 2+1 or 3+1) is not typically applicable. Safety observations and temperature measurements would likely be recorded directly by study staff.
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
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging interpretation where human readers (e.g., radiologists) use AI assistance to improve their performance. This device is not an AI diagnostic tool and does not involve "human readers" in this context.
- Effect Size: Not applicable as no such study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device functions as a standalone electrosurgical device. Its performance is evaluated on its direct physical effects (temperature, tissue response), not as an algorithm making a decision. The clinical study described evaluates the device in its intended operational mode, which is "standalone" in the sense that it directly applies energy without an AI interpretation layer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance relies on several objective and observational measures:
- Bench Testing: Direct physical measurements (temperature build-up at different power levels).
- Pre-Clinical (Animal) Study: Histopathological examination (tissue vitality, absence of necrosis) and direct temperature profiling.
- Clinical Study: Direct thermal measurements on human skin, skin observation for adverse events, and subject reports of discomfort (absence of adverse events and maintenance of target temperature profiles being the positive "ground truth").
8. The sample size for the training set
This information is not applicable/not provided as the EmFace Device is an electrosurgical device, not an AI/machine learning model that requires a training set. The device is hardware-based with software controls; it learns nothing from data.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI/machine learning model.
§ 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.