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The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.

The illumiflow Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650-nm and 5mW each. The cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included Battery Pack.

The provided text describes the regulatory clearance for the "Illumiflow Laser Cap." However, it does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/human-in-the-loop system for a medical imaging device.

The document is a 510(k) summary for a low-level laser therapy (LLLT) device intended to promote hair growth. The studies mentioned are primarily:

• Biocompatibility testing: To ensure materials are safe for patient contact.
• Non-clinical performance testing: To confirm compliance with design specifications and electrical safety/EMC standards (e.g., IEC 60825-1, IEC 60601-1).
• Usability testing: To confirm that lay users can understand labeling and use the device safely and correctly.

There is no mention of:

• A table of acceptance criteria for diagnostic/AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used to evaluate AI performance.
• Data provenance for such test sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness with human readers.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set details (size, ground truth establishment).

The device is a direct-to-consumer therapy device, not a diagnostic imaging device utilizing AI. Therefore, the detailed AI-related study information you requested is not present in this document.

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