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Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Diamond Air+ (Model: UI04A, UI04B, UI04C) is a light-based device for long-term hair removal intended to be sold over-the-counter directly to the end user. The subject device is identical to that cleared via K213558. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device utilizes the IPL technology with 5 Levels of output energy. The size of the device is 6038169.86mm (W x D x H). It contains a Xenon Lamp and a skin contact sensor to detect appropriate skin application. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with not start treatment.

This document describes the Ulike Co., Ltd.'s Diamond Air+ (UI04A, UI04B, UI04C) device, a light-based device for long-term hair removal.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in a quantitative manner (e.g., minimum percentage reduction in hair regrowth). Instead, it states the "Indications for Use" which defines the intended outcomes.

However, based on the Indications for Use as the implicit "acceptance criteria" through regulatory clearance, we can infer the following:

Important Note: The document explicitly states, "No new clinical performance data is reported in this submission." This means the device's performance against these indications is not newly supported by a specific study detailed within this submission. Instead, substantial equivalence to predicate devices (K213558 and K192432) is being claimed, and the performance is presumably supported by the predicate devices' data.

2. Sample size used for the test set and data provenance:

• The document states: "No new clinical performance data is reported in this submission."
• Therefore, there is no information provided on the sample size or data provenance (country of origin, retrospective/prospective) for a test set specifically for this device in this submission. The substantial equivalence relies on previously established data for predicate devices.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Given that "No new clinical performance data is reported," there's no information on experts or ground truth establishment for a test set within this submission.

4. Adjudication method for the test set:

• Given that "No new clinical performance data is reported," there's no information on adjudication methods for a test set within this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• This device is a physical hair removal device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not conducted.

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

• This device is a physical hair removal device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.

7. The type of ground truth used:

• Since no new clinical performance data is reported, the type of ground truth used for this specific submission to demonstrate performance is not explicitly detailed. However, for hair removal efficacy studies, the ground truth would typically be objective measurements of hair count reduction over time, potentially assessed by qualified professionals (e.g., dermatologists or clinical researchers) or through photographic analysis. This ground truth would have been established for the predicate devices.

8. The sample size for the training set:

• This device is not an AI algorithm requiring a training set. Therefore, this question is not applicable.

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

• This device is not an AI algorithm requiring a training set. Therefore, this question is not applicable.

In summary:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting new clinical performance data for the Diamond Air+ device itself. The "acceptance criteria" are implied by the stated indications for use, and the device's ability to meet these is supported by the regulatory history and performance of the predicate devices. Human factors testing was conducted to support the Over-The-Counter (OTC) indication, but this is a usability/safety assessment, not a clinical efficacy study about hair reduction.

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