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K Number
K192077
Device Name
Tua Face Fitness / Tua Trend Face
Manufacturer
Vupiesse S.R.L
Date Cleared
2020-09-30

(425 days)

Product Code
NFO,DEV
Regulation Number
882.5890
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
K103031
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Tua Face Fitness / Tua Trend Face is a device intended for facial stimulation and is indicated for Over-the-Counter cosmetic use.

Device Description

Tua Face Fitness /Tua Trend Face is a two-channel, battery-operated cosmetic device which is intended for use on the face. The device comprises a rechargeable electronic device which connects to an applicator wand that delivers electrical impulses to the face. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the facial area. It means that the electrodes that are positioned on the skin must be wet with tap water to be conductive to generate of the electric pulses. The pads are made of pure cellulose backed by PVC. It is a surface device which comes in contact with skin. The duration of contact is less than or equal to 24 hours.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Tua Face Fitness / Tua Trend Face device. It aims to demonstrate substantial equivalence to a legally marketed predicate device (BMR Face) and is not a report of a study proving the device meets specific performance acceptance criteria for an AI-powered diagnostic or similar type of device.

The document discusses the regulatory classification, intended use, and technological characteristics of a Transcutaneous Electrical Nerve Stimulator (TENS) for cosmetic facial stimulation. It focuses on demonstrating that the new device is as safe and effective as the predicate device by comparing their technical specifications and compliance with relevant electrical and safety standards.

Therefore, the requested information about acceptance criteria, detailed study design with sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI-driven performance cannot be extracted from this document, as it does not describe such a study.

Specifically:

  1. A table of acceptance criteria and the reported device performance: Not applicable. This document is not performing comparative testing against specific performance metrics for an AI algorithm. It's comparing technical and safety specifications of a TENS device to a predicate.
  2. Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the context of an AI performance study is described. The document relies on comparisons of device specifications and compliance with safety standards.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established or discussed.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication 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 device is a TENS unit, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to its regulatory submission.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. Ground truth for AI performance is not established.
  8. The sample size for the training set: Not applicable. No AI training set is mentioned or relevant.
  9. How the ground truth for the training set was established: Not applicable. No AI training is mentioned or relevant.

The document states "No new clinical studies have been submitted as part of this Premarket Notification," indicating that the substantial equivalence argument is based on non-clinical tests (electrical safety, EMC, biocompatibility, mechanical, thermal, and software safety/classification) and comparison of technical specifications to the predicate 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).