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The device can work in multiple function modes as following with different indication for use:

1. The red light is intended to treat periorbital wrinkles.
2. The blue light is intended to treat mild to moderate inflammatory acne.
3. The Red + IR is intended to treat periorbital wrinkles.

The TheraFace LED device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm&633 ± 10 nm), or in the blue light region of the spectrum(415±10nm).

The TheraFace LED device consists of a main control unit and its attachment applicators for the LED irradiation ring, which can be controlled by the device control button. The device is powered by one internal lithium rechargeable battery which can be charged by an external batterv charger.

Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is adjustable to one wavelength with a narrow spectral bandwidth in red light. It provides narrow bands of red-light energy and is intended to treat periorbital 633±10nm. wrinkles.

Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is adjustable to one wavelength with a narrow spectral bandwidth in 415 ±10nm. It provides narrow bands of blue light energy to facial skin, and is intended to treat mild to moderate inflammatory acne.

Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm) and IR (830 nm) spectrum on facial skin. It is intended to treat periorbital wrinkles.

This document is a 510(k) summary for the TheraFace LED device, asserting its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance metrics, or study details in the format requested.

Specifically, the document states:

• "There were no clinical studies performed." (Page 9)
• It outlines "Performance Standards Applied" (Page 8-9) which are a series of bench tests for electrical safety, electromagnetic compatibility, and biocompatibility, designed to show the device meets general safety standards, similar to predicate devices. These are not acceptance criteria related to efficacy or clinical performance.
• It mentions "PERFORMANCE TESTING BENCH" (Page 9) including a "Usability Study Report" and "TheraFace LED Light Power Density Test Report," but provides no details on acceptance criteria or results from these reports.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on technical and safety comparisons to predicate devices, not on clinical performance studies.

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The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.

The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The Console (Pressure control unit) supplies air at a regulated pressure to a compression garment worn over the area to be treated. The console contains a compressor which generates the air pressure, valves which control the outlet air, user control panel and firmware which controls the pressure and treatment cycle. The pressure control unit is powered by external DC Power Adapter, plugged into a wall electrical outlet or by a recharqeable battery which can operate the device for more than four hours. The battery is located inside the Console and can be charged while the device operates from a wall electrical outlet. The Prong Plug is used as a dummy hose plug for sealing the second air outlet to prevent air escape when the other outlet is connected to the pressure garment. The Medical grade DC Power Adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 12 VDC 3A to the Console. The DC power adaptor is also used for charging the Battery. The Battery Pack is located inside the Console's enclosure is used as backup power. When Battery is fully charged it can power the Console for more than four (4) hours. The Battery may be charged during normal operation of the console. The Battery charging time is up to 8 hours. Smart-phone application uses low power Bluetooth wireless to communicate with the Console. The application enables modifying, storage and display of the device's treatment parameters, and start/stop treatment via Bluetooth communication, similar to reference device (K190493).

The provided text describes a 510(k) premarket notification for the RecoveryAir PRO device. This type of submission is a declaration of substantial equivalence to a predicate device, rather than a demonstration of meeting specific performance acceptance criteria through the kind of clinical study typically associated with AI/software as a medical device (SaMD) clearances.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The "Performance Data" section (Page 12) refers to standard medical device testing for electrical safety, EMC, biocompatibility, and software verification/validation, which are engineering and quality control tests, not clinical performance studies for an AI/SaMD.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria for AI Performance: The device (RecoveryAir PRO) is a physical, air compression therapy device. It's regulated as a powered inflatable tube massager (21 CFR 890.5650). While it has a smartphone application with Bluetooth communication (Pages 4, 11), this appears to be for user control and display of parameters, not for an AI algorithm performing a diagnostic or prognostic function. Therefore, there are no AI-specific performance acceptance criteria in this submission.
• Study Design (Test Set, Ground Truth, Experts, MRMC, Standalone): Because the device is not an AI/SaMD performing a medical image analysis or similar task, no such studies (clinical or even retrospective data analysis focused on AI performance) were conducted or reported. The 510(k) relies on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety/EMC/biocompatibility testing, not on clinical performance derived from AI output.
• Training Set Information: Similarly, since there's no disclosed AI model for a medical function that would require a "training set" of patient data, this information is not applicable and not present.

In summary, the provided document is a 510(k) for a physical medical device. It does not provide information about AI acceptance criteria or studies proving AI performance because the device, as described, does not appear to incorporate an AI component that performs a medical function requiring such validation.

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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.

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