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Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use.

The Micro-current vibration facial cold and hot service device (Model: TPML-100) is a hand-held, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, and USB cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the USB cable. The device is un-usable when charging. The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions: a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation. b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne. c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.) d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.)

This document describes the premarket notification (510(k)) for the Micro-current vibration facial cold and hot service (model: TPML-100) device. The FDA's letter indicates that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.

However, the provided text does not contain information about acceptance criteria for performance metrics or a study proving the device meets these criteria in the context of clinical effectiveness and accuracy, especially concerning the treatment of mild to moderate inflammatory acne and facial stimulation for aesthetic use.

The document details:

• Regulatory information: Device classification, product codes, and regulatory standards.
• Device description: Features, functions (EMS, LED irradiation, vibration, warming/cooling), power supply, and materials.
• Intended Use/Indications for Use: Treatment of mild to moderate inflammatory acne and facial stimulation for aesthetic use.
• Test Summary: Lab bench testing for safety and performance against various IEC and ISO standards (electrical safety, EMC, home healthcare environment, nerve/muscle stimulation, non-laser light source, biocompatibility).
• Comparison to predicate devices: A detailed table outlining similarities and differences in technical characteristics.
• No Clinical Test conducted: Explicitly states "No Clinical Test conducted."
• Usability Testing: Mentions that usability testing was conducted to ensure lay users can self-select, apply treatment safely, and understand labels, indications, contraindications, warnings, and precautions.

Based on the provided text, there is no study described that proves clinical effectiveness for the stated indications, nor are there explicit acceptance criteria for such effectiveness. The "Test Summary" section refers to engineering and biocompatibility tests, not clinical performance or accuracy in treating acne or providing facial stimulation. The substantial equivalence determination is based on the device's technological characteristics, features, specifications, materials, and intended use being similar to (substantially equivalent) predicate devices, and that the differences do not raise new safety or effectiveness issues.

Therefore, I cannot populate the requested table or answer questions related to clinical performance studies, such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, because this document explicitly states "No Clinical Test conducted" (Section 8). The performance demonstration is based on bench testing and comparison to predicate devices, not clinical efficacy trials demonstrating specific outcomes related to acne or facial stimulation.

Summary of missing information based on the prompt's requirements:

• Acceptance Criteria & Reported Performance Table: Not available as clinical performance (efficacy) studies are not detailed.
• Sample size (test set) & data provenance: Not applicable; no clinical test set described.
• Number of experts & qualifications: Not applicable; no clinical ground truth established by experts for performance evaluation.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted.
• Standalone performance study: Not conducted in a clinical efficacy context.
• Type of ground truth used: Not applicable; no clinical ground truth as no clinical study was performed.
• Training set sample size: Not applicable; no AI/ML model for clinical diagnosis or outcome prediction mentioned or trained.
• How ground truth for training set was established: Not applicable.

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