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The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch 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.

The SSC1 device is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.

The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "SmoothSkin Pure Switch (SSC1)," an Intense Pulsed Light (IPL) hair removal device.

Crucially, this document specifies that the device's substantial equivalence is based on its similarity to legally marketed predicate devices, not on a clinical study demonstrating its performance against specific acceptance criteria for a new AI/algorithm-driven diagnostic/prognostic device.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm. The clearance is based on the device's technical specifications and intended use being similar to existing cleared devices, and compliance with general safety and performance standards (electrical safety, EMC, biocompatibility), rather than a specific demonstration of diagnostic/prognostic accuracy or the improvement of human reader performance.

The document does not contain:

• A table of acceptance criteria and reported device performance for an algorithm.
• Sample sizes for a test set for an algorithm.
• Information on experts for ground truth establishment.
• Adjudication methods for a test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth for an algorithm.
• Training set sample size or ground truth establishment for a training set.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section primarily lists compliance with various electrical safety, electromagnetic compatibility, and biocompatibility standards. It does not describe a clinical study in the sense of demonstrating a new diagnostic or prognostic capability's accuracy or impact on human performance.

In summary, the provided text does not contain the information requested for AI/algorithm performance studies and acceptance criteria, as the device's clearance is based on predicate device equivalence and compliance with general device safety standards.

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The SmoothSkin Pure Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged 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.

The SmoothSkin Pure Unplugged is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is battery powered and charged by mains. The handset with removal battery pack, Handset Dock station, and AC Adapter. AC mains is fed to the AC Adapter and converted to DC to charge the battery pack via the docking station contact pins, the device cannot be used when charging. The battery pack is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.

Please provide the input document. The provided text is a generic FDA 510(k) clearance letter and summary, which describes a medical device (SmoothSkin Pure Unplugged) but does not contain any information about the acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-enabled device as suggested by the detailed criteria you've outlined.

The document discusses:

• The device's name and regulation
• Comparison to predicate devices
• Technological characteristics and minor changes (energy source, electrical architecture, software for battery management, aesthetics)
• Compliance with electrical safety, EMC, biocompatibility, and software (IEC 62304) standards.

There is no mention of:

• A test set size, data provenance, or a study to prove performance against specific clinical or AI-related metrics.
• Experts establishing ground truth, adjudication methods, or MRMC studies.
• Standalone algorithm performance or a training set.
• Any performance metrics like sensitivity, specificity, AUC, etc., which would be typical for an AI/ML device's acceptance criteria.

Therefore, I cannot fulfill your request using the provided text. To answer your question, I would need a document that describes:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity, F1-score) as acceptance criteria.
• Details of a study (clinical trial or non-clinical validation) that measures these metrics.
• Information on the datasets used (size, type, source).
• Details about how ground truth was established, including expert involvement and adjudication.
• Information about training data for an AI/ML model, if applicable.

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The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt 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.

The SmoothSkin Pure Adapt is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use.

The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp.

Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair sharty is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.

The provided document is a 510(k) Summary for the SmoothSkin Pure Adapt (SSG3) hair removal device. It details the device's intended use and compares it to a predicate device. However, it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the way you are asking about (e.g., performance metrics like sensitivity/specificity, human reader studies, or ground truth establishment).

The non-clinical and/or clinical tests summary section (page 5) lists compliance with various standards related to electromagnetic compatibility, usability, essential performance, photobiological safety, and biocompatibility. These are general safety and performance standards for medical devices, not specific performance criteria for hair removal efficacy or accuracy that would involve a test set, ground truth, or expert review in the way you described for AI/CAD systems.

Therefore, I cannot provide answers to most of your numbered points based on the information given. The document focuses on showing substantial equivalence to a legally marketed predicate device by demonstrating similar technological characteristics and compliance with recognized safety and performance standards.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• The document primarily demonstrates compliance with various safety and performance standards (e.g., IEC 60601 series, ISO 10993 series), rather than specifying quantitative performance acceptance criteria for hair removal efficacy in terms of metrics like sensitivity or specificity.
• For hair removal efficacy, the acceptance criterion implicitly comes from showing substantial equivalence to the predicate device, which is also indicated for "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." The document states "Same indications for use," implying the device is expected to achieve similar results as the predicate. However, no specific performance data (e.g., percentage reduction in hair regrowth) is provided from a study to meet this.

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

• Not provided. No specific test set for hair removal efficacy is described.

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

• Not applicable. The document does not describe a study involving expert-established ground truth for performance.

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

• Not applicable.

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 an IPL hair removal device, not an AI/CAD system assisting human readers.

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

• Not applicable.

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

• Not applicable for the types of studies you are referring to. The device's "ground truth" for its intended use is likely based on the clinical outcomes of the predicate device.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through technological comparisons and compliance with recognized standards, rather than detailing a specific clinical performance study with defined acceptance criteria and test sets for efficacy.

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The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure Mini 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.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to CyDen Limited for their device, SmoothSkin Pure Mini, a hair removal device. This document primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is regulatory approval, not a scientific study report.

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The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure is also indicated for the permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Not Found

This document is an FDA 510(k) clearance letter for the SmoothSkin Pure hair removal device. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the detailed information requested in your prompt based solely on the provided text. The document focuses on regulatory clearance, not on a detailed scientific study report for performance.

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