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The Dermatological Diode Laser (Model: Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.

The Hakon and Hakon Smart device is a micro-controlled equipment used in diode laser therapies at wavelengths of 808nm intended to remove unwanted hair.

The provided text is a 510(k) summary for the Hakon and Hakon Smart dermatological diode laser for hair removal. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device.

Unfortunately, the document does not contain the requested information regarding acceptance criteria and the results of a study proving the device meets those criteria, specifically concerning AI/algorithm performance.

The document states:

• "No clinical trial was performed."
• The "Non-Clinical Evaluation (Performance and Safety Evaluation)" section refers to compliance with recognized international regulations and standards for safety and electrical compatibility (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1). These standards primarily address the physical and electrical safety of the device, not its clinical effectiveness or specific performance metrics related to hair reduction beyond its intended use as a laser.
• The device is a laser surgical instrument, not an AI-based diagnostic or treatment planning system that would typically have performance metrics like sensitivity, specificity, or AUC based on clinical data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or clinical effectiveness studies in the format requested, as this information is not present in the provided text.

The document focuses on establishing substantial equivalence to a predicate device (K210663) based on:

• Indications for Use: Identical for both devices (permanent hair reduction on all Fitzpatrick skin types).
• Technological Characteristics: Similar principle of operation (diode laser), class, product code, and safety standards. There are some observed differences in spot size, fluency, pulse duration, power supply, dimensions, and weight, but the submitter argues these differences do not compromise efficiency, effectiveness, or safety.

In summary, none of the requested information regarding AI/algorithm performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies is available in the provided text. The device is a physical laser instrument, and its evaluation in this document focuses on engineering and regulatory compliance standards rather than algorithmic performance.

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