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The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift PLUS is composed of a mask made of silcone 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 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. The device is not operated during charging.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a medical device (Medi Lift PLUS) and focuses on establishing substantial equivalence to a predicate device.

The "Performance Data" section lists several compliance standards (e.g., IEC, ISO) and tests (e.g., chemical characterization, tensile strength, electrical output, software verification). These are typically related to safety, electrical performance, biocompatibility, and manufacturing quality, rather than clinical efficacy or diagnostic accuracy.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, training set sample size, ground truth for training set) are not applicable or cannot be extracted from this document, as they pertain to clinical performance studies, which are not detailed here.

However, I can provide information based on the available text regarding the characteristics of the device and its safety/performance testing in a regulatory context.

Here's an attempt to answer the questions based only on the provided text, noting its limitations:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance (e.g., a specific improvement percentage in facial stimulation) or directly report "device performance" in that context. Instead, it lists standards the device was assessed against, which imply that compliance with these standards is the "acceptance criterion" for regulatory approval of substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The listed performance data relates to engineering and biocompatibility testing, not human clinical trials with a test set of patients or subjects.

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)

This information is not provided. "Ground truth" in the context of facial stimulation for cosmetic use is not typically established by experts in the same way it would be for a diagnostic medical device (e.g., diagnosis of disease). The document focuses on safety and technical specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication of "ground truth" is described.

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. The Medi Lift PLUS is a transcutaneous electrical nerve stimulator for cosmetic facial stimulation, not an AI-assisted diagnostic or screening device involving human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm, but a physical electrical stimulator.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable for clinical efficacy in the sense of comparing against a definitive medical diagnosis. The "ground truth" in this context would be compliance with the performance specifications of the device itself and safety standards.

8. The sample size for the training set

Not applicable. The Medi Lift PLUS is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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