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

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for the treatment of psoriasis in patients with Fitzpatrick skin types I - VI.

The provided text is a 510(k) Summary for the Radiancy SkinStation® with Modified Light Unit Assembly for Psoriasis Treatment. It describes the device, its intended use, and substantial equivalence to predicate devices, but does not contain a study or data proving the device meets specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to already cleared devices, a regulatory pathway that doesn't necessarily require new clinical studies with defined acceptance criteria to be submitted or summarized in the 510(k) application itself. The statement "The new psoriasis indication for use is based upon the indications for use for two already cleared predicate pulsed light device Systems" further supports this, suggesting reliance on prior approvals rather than new performance data for this specific 510(k).

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The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for hair removal in Fitzpatrick Skin Types V and VI.

The provided text is a 510(k) summary for the Radiancy SkinStation Photoepilation System with Modified Light Unit Assembly for Hair Removal. This document focuses on demonstrating substantial equivalence to predicate devices for a specific medical device. It does not include details about acceptance criteria, study designs, sample sizes for training or test sets, expert qualifications, or ground truth establishment in the manner typically associated with AI/ML device evaluations.

Therefore, most of the requested information cannot be extracted from this document because it describes a traditional medical device (a light-based hair removal system) and its regulatory submission, not a software as a medical device (SaMD) or an AI/ML-powered device. The study mentioned is a clinical data study to show the device's effectiveness for hair removal in specific skin types, not an "AI evaluation study."

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is typically found in the clinical study results section of a 510(k) submission when performance metrics are explicitly defined. The provided summary states: "Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI with only minor side effects."
However, it does not state specific quantitative acceptance criteria (e.g., "X% hair reduction required") or detailed performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary.
• Retrospective or Prospective: Not specified in the provided summary, but clinical trials for device approval are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This question is not applicable to this type of device and study. The "ground truth" for a hair removal device is the actual hair reduction observed clinically, assessed by practitioners and potentially by patients, not by experts establishing a categorical ground truth like in AI/ML image analysis. No details about "experts" establishing ground truth are provided.

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

Not applicable. This concept is relevant for AI/ML studies where multiple human readers review cases to establish a consensus ground truth. For a hair removal device, performance is typically assessed by clinical observation of hair reduction and adverse events.

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 is an AI/ML specific study type. The device is a direct treatment device, not an AI assistant for human readers.

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

Not applicable. This device is a hardware-based system. "Standalone" performance generally refers to an algorithm's performance without human interaction, which doesn't fit a physical light-based hair removal system.

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

Based on the context of a hair removal device, the "ground truth" would implicitly be outcomes data related to hair reduction and adverse events observed clinically.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of AI/ML.

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

Not applicable. This device does not use a "training set" in the context of AI/ML.

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The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.

The SkinStation is a pulsed light device intended for hair removal and treatment of pigmented and vascular lesions. When operated in the hair removal mode, the Skin Station is identical to the previously cleared SpaTouch, except that it is now housed with the SPR module for treating pigmented and vascular lesions. When operated in the pigmented and vascular lesions mode (i.e., using the SPR handpiece), the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the cleared Quantum, with a few exceptions which do not raise new issues of safety and effectiveness. In addition, the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the previously cleared MBC's Prolite and Palomar's EsteLux when operated in the SPR mode

I am sorry, but the provided text does not contain any information about acceptance criteria or a study to prove the device meets acceptance criteria. The document is a 510(k) summary for the Radiancy SkinStation™ System, primarily discussing its substantial equivalence to predicate devices for its intended use of hair removal and treatment of pigmented and vascular lesions. It does not detail specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment.

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