(16 days)
The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.
This document is a 510(k) Summary for the Medi Lift Mask, a medical device. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data for a new AI/software-driven device.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria for an AI-driven device cannot be extracted from this document, as the device is not an AI/software device and the clearance is based on substantial equivalence and minor material change, not a performance study of AI.
However, I will extract what is available and note what is not applicable or not provided.
Here's the breakdown based on the provided text:
Device Type: Transcutaneous Electrical Nerve Stimulator For Pain Relief (Aesthetic Purposes) – This is a hardware device, not an AI/software device.
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria for a performance study in the way an AI/software device submission would. Instead, it demonstrates equivalence to a predicate device. The "performance" described is in the context of safety and effectiveness, shown by:
- Risk Analysis: Per ISO 14971:2019 (determined no new risks compared to predicate).
- Biocompatibility Evaluation: Per ISO 10993-1:2018, with testing for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2021), and Intracutaneous reactivity (ISO 10993-23:2021).
- Prior Tests (Applicable to predicate, deemed still applicable to new device due to no relevant changes): Tensile strength, polycyclic aromatic hydrocarbons, software verification and validation, electrical stimulation outputs, electrical safety, and electromagnetic compatibility.
| Acceptance Criteria Category | Reported Device Performance/Conclusion |
|---|---|
| Safety (Risk Profile) | Risk analysis per ISO 14971:2019 determined no new types of safety and effectiveness questions compared to the predicate due to the UV varnish change. |
| Biocompatibility | Met ISO 10993-1:2018 requirements, confirmed by: |
- Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2021
- Intracutaneous reactivity per ISO 10993-23:2021 |
| Effectiveness (Equivalence) | "The Medi Lift Mask has the same intended use and indications for use as the predicate device... Thus, the Medi Lift Mask is substantially equivalent." |
| Material Change Impact | The new UV varnish on the controller housing "does not raise different types of safety and effectiveness questions." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a clinical performance study for an AI algorithm. The testing described is primarily material and electrical safety/biocompatibility testing, which typically uses defined sample sizes for specific component tests as per standards, but a "test set" of patient data is not relevant here.
- Data Provenance: Not applicable for patient data. The provenance of the testing conducted would be controlled laboratory conditions in Japan (where YA-MAN Ltd. is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI diagnostic/prognostic device requiring expert-established ground truth from medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device revolves around established safety standards (ISO for biocompatibility, electrical safety) and the functional equivalence to the cleared predicate device.
8. The sample size for the training set
- Not applicable. This device does not use a training set for machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not use a training set for machine learning.
Summary of the K244048 Submission:
The provided text is an FDA 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (Medi Lift Mask). The submission seeks clearance based on substantial equivalence to a previously cleared predicate device (Medi Lift PLUS, K220198). The primary "change" is a different UV varnish material on the controller housing.
The testing performed and documented focuses on confirming that this minor material change does not introduce new safety or effectiveness concerns. This is demonstrated through:
- Risk analysis (confirming no new risks).
- Biocompatibility testing of the new material.
- Reliance on prior testing of the predicate for aspects not affected by the material change (electrical safety, software, etc.).
Therefore, the document does not contain the information typically found in an FDA submission for an AI/software device that requires extensive clinical performance studies with defined acceptance criteria for AI model performance (e.g., sensitivity, specificity, accuracy against human readers or pathology).
§ 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).