(208 days)
The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.
The CurrentBody Skin RF device 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 PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
The provided text describes the regulatory clearance of the CurrentBody Skin RF device, focusing on its substantial equivalence to a predicate device. As such, it details non-clinical testing and comparisons rather than comprehensive acceptance criteria for a "study that proves the device meets the acceptance criteria" in the way one might expect for a new, AI-driven diagnostic device undergoing clinical trials.
The document emphasizes demonstrating substantial equivalence through bench tests, electrical safety, software validation, human factors, and thermal effects, rather than through a direct clinical performance study with specific effectiveness endpoints measured against acceptance criteria against a ground truth.
Therefore, many of the requested elements for a typical effectiveness study (e.g., sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this submission. The device is not an AI-driven diagnostic.
Here's an analysis based on the information available:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in the traditional sense of clinical effectiveness endpoints. Instead, it demonstrates that the new device meets various safety and performance standards, and is substantially equivalent to a predicate device in its technical specifications and intended use. The "acceptance criteria" are implied by compliance with these standards and equivalence to the predicate.
| Category | Acceptance Criteria (Implied by Standards/Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV (OTC home use) | Matches the predicate device's intended use. |
| RF Energy Specifications | Similar RF frequency and electrical power to predicate device. | - Maximal power output: 5 ± 1 Watt |
- Frequency: 1 ± 0.05 MHz
- Operating RF Power (200 Ohms): $5W \pm 1$
- Total Power Density (fluence): $5 W/cm^2 \pm 1$ |
| Temperature Control | Maintain temperature within target treatment range (e.g., maximal temperature of $40.5 \pm 0.5^\circ C$). | Two redundant thermistors constantly measure skin temperature and alter power to maintain constant temperature. |
| Power Accuracy | Measured total power within error margin on a 200 Ω load. | Measured total power was within the error margin. |
| Parameter Validation | Varied parameters (RF, pulse cycle, waveform, pulse duration) within acceptance criteria. | All results were within the acceptance criteria. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-2. | The device complies with these standards. |
| Software Verification & Validation | Compliance with FDA Guidance for Software in Medical Devices ("moderate" level of concern). | Software verification and validation testing were conducted and documentation provided as recommended. |
| Human Factors Validation | Users can safely and effectively self-select, prepare, and perform treatment. | A Self-Selection and Human Factors validation study was performed to demonstrate this. |
| Thermal Equivalence | Spatio-temporal heating profile comparable to predicate device. | Measurements showed comparable (near identical) spatio-temporal tissue heating in porcine belly skin. |
| Biocompatibility | All patient-contacting parts comply with ISO 10993-1. | Compliance with ISO 10993-1 demonstrated. |
Study Details
This submission relies on non-clinical testing and comparison to a predicate device, rather than a clinical effectiveness study.
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not applicable for a clinical effectiveness study. For non-clinical tests:
- Power Accuracy, Parameter Validation: Not specified, likely small batches of devices for bench testing.
- Human Factors Validation: Not specified, but involved a user group for self-selection and treatment performance.
- Thermal Effects: "Porcine belly skin samples" – number not specified.
- Data Provenance: Not explicitly stated, but testing appears to be conducted by the manufacturer or their contracted labs (implied through the submission). The "porcine belly skin" indicates animal tissue, not human.
- Test Set Sample Size: Not applicable for a clinical effectiveness study. For non-clinical tests:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI studies (e.g., expert consensus on medical images, pathology results) is not relevant here. The "ground truth" for non-clinical tests would be the established performance standards or the predicate device's measured characteristics.
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Adjudication method for the test set: Not applicable. There was no clinical effectiveness study requiring expert adjudication of results.
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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: Not applicable. This device is not an AI-driven diagnostic and no MRMC study was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for aesthetic treatment, not a standalone algorithm. The software component, however, underwent "standalone" verification and validation to ensure its proper functioning and safety.
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The type of ground truth used:
- For Non-Clinical Tests: Engineering specifications, compliance with international standards (IEC, ISO), and the measured performance of the predicate device.
- For Thermal Equivalence: Direct comparative measurements against the predicate device on porcine tissue.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. Software verification and validation refer to testing the programmed logic and control, not training an AI model.
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How the ground truth for the training set was established: Not applicable.
§ 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.