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The Radiancy's Mistral® Device is intended to provide phototherapeutic light and heat energy to the body and is generally indicated to treat dermatological conditions. The Mistral is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.

Radiancy's Mistral Device is a Light and Heat Energy (LHE®) based multi-application device intended for the phototherapeautic treatment of: Hair Removal (HR), Skin Photo Rejuvenation (SPR), Acne Clearance (AC) and Psoriasis Care (PC), Mistral consists of a console, footswitch and interchangeable handpieces. It uses the same technology and has the same indications as the previously cleared SkinStation System.

The provided text is a 510(k) summary for the Radiancy Mistral Device. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not available in the provided document.

Here's a breakdown of the available and unavailable information:

1. Table of acceptance criteria and the reported device performance:

   • Not Available. The document does not describe specific acceptance criteria (e.g., minimum efficacy rates, safety thresholds) or quantitative performance metrics (e.g., specific percentages of hair reduction, lesion clearance, acne improvement) that the device had to meet. The submission is based on substantial equivalence, implying that its performance is expected to be similar to predicate devices, but no explicit performance data or criteria are listed.

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

   • Not Available. The document does not describe a specific clinical study with a test set, sample size, or data provenance (country of origin, retrospective/prospective). Substantial equivalence submissions often rely on existing data for predicate devices or bench testing, not necessarily new, separate clinical efficacy studies with independent test sets.

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

   • Not Available. Since no specific clinical efficacy study is described, there's no mention of experts establishing ground truth for a test set.

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

   • Not Available. For the same reason as above, no adjudication method 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 phototherapeutic light and heat energy system for dermatological conditions, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study or AI assistance is not relevant.

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

   • Not Applicable. This is a physical medical device, not a software algorithm.

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

   • Not Available. As no specific efficacy study is detailed, the type of ground truth for such a study is not specified.

8. The sample size for the training set:

   • Not Applicable/Not Available. The concept of a "training set" is typically for machine learning or AI models. This document describes a physical device, and while there would have been development and testing, it's not referred to as a "training set" in the context of AI. No performance or developmental data is provided that would involve specific sample sizes akin to a training set for an algorithm.

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

   • Not Applicable/Not Available. Again, the concept of "ground truth" for a "training set" does not apply here in the AI context.

Summary of what is available:

The document establishes substantial equivalence of the Radiancy Mistral Device to predicate devices (Radiancy SkinStation System, General Project's MED FLASH II, and McCue's Energist Ultra VPL) based on:

• Identical Intended Use and Indications for Use: Hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.
• Identical Principles of Operation: It uses Light and Heat Energy (LHE®) technology.
• Similar Technological Characteristics: Consists of a console, footswitch, and interchangeable handpieces.

The basis for market clearance (510(k)) is that the differences between the Mistral and its predicate devices "do not raise new issues of safety and effectiveness." This means the FDA accepted that the device's performance would be equivalent to the already cleared predicate devices, without requiring new, specific clinical efficacy data to be presented in this summary document. Performance data for the predicate devices would have been previously reviewed.

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