(72 days)
The TheraFace microcurrent is a hand-held device for over-the-counter aesthetic purposes . The TheraFace microcurrent is indicated for facial stimulation.
The TheraFace microcurrent device consist of main control unit and its attachment applicators for microcurrent output which can be control by the device control button or APP in cell phone via Bluetooth connection. The device powered by one internal lithium rechargeable battery which can be charged by external battery charger. The device has the electrode contractors for facial stimulation by applying an electrical micro current to face skin. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 3 levels of output intensity, which can be adjusted by user. The low-level electrical current pulse goes through the face muscle and cause face muscle contraction for facial stimulation.
The provided text is a 510(k) premarket notification for the TheraFace microcurrent device. This type of FDA submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving independent effectiveness through a rigorous clinical trial with defined acceptance criteria and human-in-the-loop studies.
Therefore, the document does not contain the specific information requested about acceptance criteria for device performance as a standalone, human-in-the-loop, or a multi-reader multi-case (MRMC) study, nor does it detail a study proving the device meets such criteria.
Instead, the submission demonstrates equivalence by:
- Comparing the device's technical specifications and indications for use to a previously cleared predicate device (2 Face / Face Evolution - K171821). The core of the argument is that because the new device's parameters are similar to a device already deemed safe and effective for the stated purpose, it too is safe and effective.
- Adhering to relevant electrical safety, EMC, and biocompatibility standards. This ensures the device itself is safe to operate and materials are biologically compatible.
Here's a breakdown of what can be extracted from the document, and what is missing based on your specific questions:
Information Present in the Document:
1. A table of acceptance criteria and the reported device performance:
* The document presents a comparison table (pages 4-6) showing the "Elements of Comparison" between the "Subject Device" (TheraFace microcurrent) and the "Primary Predicate Device" (2 Face / Face Evolution).
* This table serves as the "acceptance criteria" by proxy. The implicit acceptance criterion is that the new device's specifications should be "substantially equivalent" to the predicate, meaning similar enough not to raise new questions of safety or effectiveness. The "Reported Device Performance" for the TheraFace microcurrent is its listed specifications.
* Example from table:
* Element: Maximum Output Voltage (+/- 10%)
* Subject Device: 0.24V @ 500Ω; 1.0V @ 2kΩ; 5.0V @ 10kΩ
* Predicate Device: 0.31V @ 500Ω; 1.16V @ 2kΩ; 5.56V @ 10kΩ
* Remark: SE (Substantially Equivalent) - Note 3 explains why this difference is considered SE.
* The "Remarks" column often indicates "SE" (Substantially Equivalent), sometimes with cross-references to "Notes" (pages 8-9) that provide justification for minor differences. This is the primary method of "proving" the device meets the "acceptance criteria" of being substantially equivalent to the predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* The document describes the device as a "hand-held device for over-the-counter aesthetic purposes" intended for "facial stimulation" (page 4).
* The performance is assessed by comparing its electrical output characteristics (waveform, voltage, current, frequency, pulse width) and safety features (automatic overload/no-load trip, shut-off) to the predicate device.
* This comparison to a predicate device is the "standalone" performance assessment in the context of a 510(k) for this type of device. There's no AI or algorithm that produces an output that would require a separate "standalone" performance evaluation in the way one might assess an AI diagnostic tool. The "software/firmware/microprocessor control" is noted, but its performance is implied to be acceptable if the device's electrical output specifications are met and it complies with relevant safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
* For the TheraFace microcurrent specifically, the evaluation relies on compliance with recognized consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 for electrical safety/EMC, and ISO 10993-5, ISO 10993-10 for biocompatibility). These standards inherently represent a form of "ground truth" for safety and performance for medical devices.
* There is no clinical "outcomes data," "pathology," or "expert consensus" in the sense of a diagnostic agreement presented in this 510(k) submission.
8. The sample size for the training set:
* Not applicable. This device is a transcutaneous electrical stimulator, not an AI/ML device that requires a "training set" for an algorithm. Its performance is based on its physical and electrical characteristics.
9. How the ground truth for the training set was established:
* Not applicable, as there is no training set for an AI/ML algorithm.
Information NOT present in the document (and why it's not applicable to this type of 510(k) submission):
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No "test set" in the sense of a clinical data set is referenced. Performance is assessed through engineering testing against standards and comparison to a predicate.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth is based on engineering standards and the predicate device's existing clearance.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable due to the absence of a clinical "test set" requiring adjudication.
- 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. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting output.
- Any numerical "performance" metrics for specific clinical outcomes (e.g., percent reduction in wrinkles, skin firmness improvement, etc.). The 510(k) process for this device type does not typically require clinical performance data beyond demonstrating electrical and physical equivalence to a predicate and compliance with safety standards.
In summary, this 510(k) primarily demonstrates the TheraFace microcurrent's safety and effectiveness by establishing its "substantial equivalence" to a previously cleared predicate device and compliance with relevant engineering and biocompatibility standards, rather than through a clinical study with traditional acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).