(581 days)
"Myolift QT" is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
The MyoliftQT is a microcurrent, handheld, and mobile application-based device which is easy to operate. The mobile application used in the device supports both types of users (iPhone®/Android™). The user has to download the application via Google Play™ store (Android) /App Store® (IOs) and connect the device via Bluetooth of their phone. The users can thereafter make their profiles accordingly.
The purpose of this device is to lift and tone the face and neck. It is a battery-powered device used with conductive gel. The conductive gel is used to reduce the impedance between the electrodes and the skin of the user.
Myolift QT has one channel and two output ports. One output is through the applicator ball and the other output is through the lead wire via the USB port connected through the charging port.
The Lead wire is connected to the device via USB. And electrodes are connected through the lead wire to give skin treatment to the user. The Metal balls and the electrodes are in contact with the user/patient maximum of 60 min, therefore the Surface-contacting, less than 24hour duration.
The Sphere shape applicator balls made up of stainless steel in this device are designed to gently roll over the skin to deliver low-level electrical impulses in the face and neck region. The device delivers current in the range of 350 microamperes and low 160-microampere current.
Note: During treatment, only one output port works.
In skin treatment, the device minimize the fine lines and wrinkles on the skin.
This device delivers two types of waveforms (Erase and Educate) for effective skincare treatment.
It is intended to be used by multiple users (multiple applications). The device can be switched ON|OFF by simple touch on the power button.
The device offers multiple LED indications (Visual) to indicate the different states of the device.
- -A flashing blue LED light indicates that the device is ON|OFF and when the device is connected to Bluetooth, the flashing blue light becomes steady.
- -A Red LED indicates battery low while A Green LED indicates the chagrining of the device
lt is a portable device having dimensions 6.65″ x 1.49″ [ L X B X H ]. Its outer case is made up of thermoplastic resin. The device comes with a C-type USB cable for the charging of the device. The device is automatically turned off if it is not connected via Bluetooth or not operated for more than 10 minutes.
This document is a 510(k) Summary for the Myolift QT device, which is a Transcutaneous Electrical Nerve Stimulator for cosmetic use. The summary focuses on demonstrating substantial equivalence to a predicate device (ZIIP+ Device, K212342) rather than presenting a performance study with acceptance criteria in the typical sense for an AI/ML medical device.
Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or not provided in this document. The "acceptance criteria" here are based on meeting various electrical safety, biocompatibility, and quality standards, and demonstrating technological characteristics similar to the predicate device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily assessed through its adherence to various regulatory and safety standards, and by comparing its electrical output parameters to those of the predicate device. The "acceptance criteria" are implied by compliance with these standards and the demonstration of substantial equivalence.
| Acceptance Criteria (Implied by Compliance) | Reported Device Performance (Summary of Findings) |
|---|---|
| Electrical Safety Standards: |
- IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests)
- IEC 60601-1-11 (Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- IEC 60601-2-10 (Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) | Compliant with IEC 60601-1, 60601-1-2, 60601-1-11. (Specific results like patient leakage current, overload/no-load trip described as within limits based on circuit design). |
| Quality Management Systems: - ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes)
- 21 CFR 820 (Quality System Regulation) | Covered by the manufacturer's quality system. |
| Risk Management: - ISO 14971 (Medical devices – Application of risk management to medical devices) | Compliant with ISO 14971. |
| Usability Engineering: - IEC 62366 (Medical devices – Application of usability engineering to medical devices) | Compliant with IEC 62366. Ergonomic handheld design noted. |
| Biocompatibility: - ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | Biocompatible materials used, identical to predicate device. |
| Wireless Capability: - 47 CFR Part 15 FCC requirements of the Equipment Authorization - RF Device | Compliant with 47 CFR Part 15 FCC requirements. Uses Bluetooth Low Energy (BLE). |
| Functional Equivalence to Predicate Device: - Indications for Use: "facial and neck stimulation and… over-the-counter cosmetic use."
- Mechanism of Action: Microcurrent electrical therapy.
- Power Source: Internal Rechargeable Lithium-Ion Battery.
- Output Parameters (Mode: Erase):
- Waveform: Symmetrical Biphasic Square wave
- Max Output Voltage: 175 mV @500Ω, 684 mV @ 2KΩ, 3.20V @ 10KΩ
- Max Output Current: 350μΑ @ 500Ω, 342μΑ @ 2ΚΩ, 320μΑ @ 10ΚΩ
- Max Phase Charge: 17.5 μC @ 500Ω
- Output Parameters (Mode: Educate):
- Waveform: Symmetrical Biphasic Square wave
- Max Output Voltage: 175 mV @500Ω, 640 mV @ 2KΩ, 3.2V @ 10KΩ
- Max Output Current: 350mA @ 500Ω, 320mA @ 2KΩ, 320mA @ 10KΩ
- Max Phase Charge: 5.25 μC @ 500Ω
- Other features: Mobile application, auto shut-off, patient override control, LED indicators. | Identical indications for use.
Identical mechanism of action.
Identical power source.
Output parameters for both "Erase" and "Educate" modes were presented and compared to the predicate device. While specific values differ (e.g., maximum output voltage/current, maximum phase charge), the document concludes these "minor differences… do not raise any questions regarding the safety and effectiveness" and that "The electrical values are within the limits as per the "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a physical device, not an AI/ML model. Therefore, "test set" and "data provenance" in the context of an AI/ML study are not applicable. The device undergoes "non-clinical bench testing" to demonstrate compliance with standards and equivalence. No patient data is involved in this described testing.
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. This is not an AI/ML device requiring human expert annotation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set is mentioned.
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/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is established through its compliance with recognized electrical safety standards (IEC 60601 series), biocompatibility standards (ISO 10993-1), and quality management systems (ISO 13485, 21 CFR 820), as well as demonstrated similarity in technological characteristics and intended use to a legally marketed predicate device. There is no "ground truth" derived from patient outcomes or expert consensus for AI model training/testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set with ground truth.
§ 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).