(366 days)
The Pobling MITY 2 is intended for facial stimulation and is indicated for over-the counter cosmetic use.
Pobling MIITY 2 is a facial toning device and it is composed of main unit and adaptor. The micro-current is delivered to healthy facial skin through head of main unit to stimulate the face. The device is a battery-powered and hand-held device. There have heating and cooling function by pressing the button additionally.
The document describes the acceptance criteria and supporting studies for the Pobling MIITY 2, a Transcutaneous Electrical Nerve Stimulator for facial stimulation. The primary study presented is a comparison with predicate devices to demonstrate substantial equivalence, rather than a standalone clinical trial or MRMC study.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices (Carol Cole Company, NuFACE® Plus, K103472 and Nu Skin Enterprises, Inc., NuSkin Facial Spa, K122711) across various technical characteristics and safety standards. The reported device performance is presented as a direct comparison in the table on page 4.
| Feature | Acceptance Criteria (Implied by Predicate Performance) | Pobling MIITY 2 Performance |
|---|---|---|
| Regulation Number | 21 CFR § 882.5890 | 21 CFR § 882.5890 |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator | Transcutaneous Electrical Nerve Stimulator |
| Regulatory Class | Class II | Class II |
| Product Code | NFO | NFO |
| Intended Use | Stimulate the face | Stimulate the face |
| Indication for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use |
| Power Source | Battery operated | Battery operated |
| Number output channels | 1 | 1 |
| Automatic shut off | Yes | Yes |
| Indicator Display (ON/OFF) | Yes | Yes |
| Indicator Display (Low-Battery) | Yes | Yes |
| On Time (seconds) | Constant | Constant |
| Off Time (seconds) | None | None |
| Compliance with Voluntary Standards | IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-11 | IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-11 |
| Mode | One to Five (Predicate NuSkin Facial Spa) / One (Predicate NuFACE® Plus) | Two |
| Waveform | Pulsed Monophasic (Predicate NuFACE® Plus) / Direct Current (Predicate NuSkin Facial Spa) | Direct |
| Maximum Output Voltage (@500Ω) | 137mV (NuFACE® Plus); 188mV-184mV (NuSkin Facial Spa) | Mode1: 174mV |
| Mode2: 174mV | ||
| Maximum Output Voltage (@2kΩ) | 769mV (NuFACE® Plus); 722mV-741mV (NuSkin Facial Spa) | Mode1: 710mV |
| Mode2: 710mV | ||
| Maximum Output Voltage (@10kΩ) | 3.82V (NuFACE® Plus); 2.626V-3.787V (NuSkin Facial Spa) | Mode1: 3200mV |
| Mode2: 3200mV | ||
| Maximum Output Current (@500Ω) | 274uA (NuFACE® Plus); 376uA-369uA (NuSkin Facial Spa) | Mode1: 350uA |
| Mode2: 350uA | ||
| Maximum Output Current (@2kΩ) | 387uA (NuFACE® Plus); 361uA-373uA (NuSkin Facial Spa) | Mode1: 360uA |
| Mode2: 360uA | ||
| Maximum Output Current (@10kΩ) | 383uA (NuFACE® Plus); 362uA-379uA (NuSkin Facial Spa) | Mode1: 320uA |
| Mode2: 320uA | ||
| Heating and Cooling | Not specified in predicates as primary function | Mode1: Heating (Temp. 41℃±3℃) |
| Mode2: Cooling (Temp. 10℃±3℃) | ||
| Weight | 9oz (NuFACE® Plus); 120g (NuSkin Facial Spa) | 115g |
| Dimensions | 3"x5.25"x1.25" (NuFACE® Plus); 143x31.2x67.5mm (NuSkin Facial Spa - Large) | 150x500mm (unit) |
| Housing material and construction | Thermo Plastic (NuFACE® Plus); ABS, Chrome plate, ABS, rubber (elastomer) (NuSkin Facial Spa) | ABS |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests beyond the overall device. The testing described for electrical safety, EMC, biocompatibility, technical characteristic, and thermal safety would involve a sample of the Pobling MIITY 2 device(s) itself.
- Data Provenance: The document does not specify the origin (e.g., country) of the data for the tests. It refers to "our testing method" and compliance with international standards (IEC, ISO). The comparison data for the predicate devices would be from publicly available information or submissions related to those devices. The study is non-clinical performance assessment.
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, as the study is a non-clinical performance assessment comparing the device to predicates and demonstrating compliance with technical standards. There is no mention of experts establishing ground truth for a test set in the context of diagnostic performance or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable, as the study is a non-clinical performance assessment and not a reader study.
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool, but rather a direct-action therapeutic (stimulating) device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was conducted for the Pobling MIITY 2 device, focusing on its technical characteristics, electrical safety, EMC, biocompatibility, and thermal safety. The device's performance was evaluated independently to ensure it met relevant standards and its characteristics were comparable to predicates. There is no algorithm involved; it's a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical performance tests was based on:
- Compliance with international standards: IEC 60601-1, IEC 60601-1-2, ISO 10993.
- Technical specifications: Measured output voltage and current values compared against the reported values of the predicate devices.
- Functional verification: For heating and cooling properties.
There is no "expert consensus," "pathology," or "outcomes data" in the typical sense as this is a non-clinical technical and safety assessment for a device without a diagnostic or complex analytical function.
8. The sample size for the training set:
This information is not applicable as the device is a hardware product and does not involve AI or machine learning algorithms that require a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
§ 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).