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The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, blue light modules are indicated to treat mild to moderate inflammatory acne.

The Tanda Mini Skincare System is a smaller version of its predicate device (K080951) that shares the same principal features and characteristics as the predicate. Both the devices are cordless, handheld units that have a single on/off push button that activates the units. The Tanda Mini Skincare System uses the same technology to deliver blue light at 414 nm to the treatment surface via light emitting diodes (LEDs) as its predicate. Furthermore, there have been no modifications to the safety features of its predicate, which includes a sensor for skin contact and temperature as well as sound indicators. The only changes made in the Tanda Mini Skincare System compared to the previously cleared predicate relates to additional ergonomic features such as a textured treatment surface, and a vibration indicator to signify the treatment is in progress. Furthermore, the total energy dose, dose rate, and treatment regimen remain the same as the previously cleared predicate device.

The provided text describes a 510(k) summary for the Tanda Mini Skincare System. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a new clinical study to establish efficacy. Therefore, much of the requested information regarding a study proving acceptance criteria for device performance is not explicitly available in the provided document.

Here's a breakdown of the information that can be extracted, and where limitations exist:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific acceptance criteria for clinical performance (e.g., reduction in acne lesion count) or a direct comparison of such performance between the Tanda Mini Skincare System and its predicate. Instead, the acceptance criteria are related to engineering and safety standards.

The document states, "In all instances, the Tanda Mini Skincare System functioned as intended," indicating that it met the acceptance criteria for these non-clinical tests. The core argument for substantial equivalence relies on the Tanda Mini having the same identical intended use and principle of operation and delivering energy at the same dose and dose rate as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document details non-clinical engineering and safety tests rather than a clinical trial with a "test set" of patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. As no clinical study against a ground truth is reported for the Tanda Mini Skincare System, this is not applicable.

4. Adjudication Method for the Test Set

This information is not provided. Not applicable due to the lack of a reported clinical test set.

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

An MRMC comparative effectiveness study was not performed. This device is a light-emitting diode therapy system for acne, not an AI-powered diagnostic or assistive tool, so this type of study is irrelevant.

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

A standalone performance study as described (algorithm only without human-in-the-loop) was not performed. This device is a direct application therapy device, not an algorithm.

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

For the non-clinical tests (electrical safety, EMC, software, biocompatibility), the ground truth is adherence to the specified international standards (e.g., IEC 60601-1, IEC 62304, IEC 10993). For the efficacy of treating acne, the device relies on the established efficacy of its predicate device with its identical treatment parameters. The predicate's efficacy would have presumably been established through clinical trials using outcomes data (e.g., lesion count reduction, global assessment scores) or expert consensus. This document, however, does not detail the specific ground truth strategy for the predicate.

8. The Sample Size for the Training Set

This information is not provided. The document describes a medical device, not a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not provided. Not applicable, as this is not an AI/machine learning device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Tanda Mini Skincare System meets "acceptance criteria" is a series of non-clinical engineering and safety tests and a demonstration of substantial equivalence to a previously cleared predicate device (K080591).

• Study Design: The approach was to confirm that modifications (primarily ergonomic) to the device did not introduce new risks and that the device maintained the same fundamental technological characteristics and safety features as the predicate.
• Key Tests Conducted:
  • Electrical safety (IEC 60601-1: 2005)
  • Electromagnetic compatibility (IEC 60601-1-2: 2007)
  • Software verification and validation (IEC 62304: 2006)
  • Biocompatibility testing (IEC 10993)
• Outcome: "In all instances, the Tanda Mini Skincare System functioned as intended" for these tests, demonstrating compliance with the respective standards.
• Efficacy Argument: The efficacy for treating mild to moderate inflammatory acne is established by demonstrating that the Tanda Mini Skincare System has the same identical intended use, principle of operation, energy type, peak wavelength, dose rate, and dose as its predicate device, K080591, which was previously deemed safe and effective. The minor ergonomic differences were not considered to raise new questions of safety or effectiveness.

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