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The IPL Hair Remover Device, Model: G993, G996, G998 and G885 is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

IPL Hair Remover, Model: G993, G996, G998 and G885 is a small prescription-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE. Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm (HWD). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

This document is a 510(k) summary for an IPL Hair Remover device, asserting its substantial equivalence to previously cleared devices. It describes the device's technical specifications and compares them to predicate devices. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance evaluation using metrics like accuracy, specificity, or sensitivity, or information about clinical trials, ground truth establishment, or expert adjudications.

The document primarily focuses on explaining why a full clinical efficacy study was not deemed necessary for this 510(k) submission, by demonstrating substantial equivalence through technical specifications and adherence to safety standards.

Therefore, I cannot extract the requested information from the provided text.

Summary of missing information based on the prompt's request:

• Acceptance Criteria & Reported Performance Table: Not provided. The document states "No clinical trial is necessary in the submission" and relies on comparisons to predicate devices for safety and effectiveness.
• Sample Size and Data Provenance for Test Set: Not applicable/not provided, as no clinical test set appears to have been used for performance evaluation in the context of AI/algorithm performance.
• Number/Qualifications of Experts for Ground Truth: Not applicable/not provided.
• Adjudication Method: Not applicable/not provided.
• MRMC Comparative Effectiveness Study: Not performed/not described.
• Standalone (algorithm-only) Performance: Not applicable/not described, as this is a physical device, not an AI algorithm.
• Type of Ground Truth Used: Not applicable/not provided.
• Sample Size for Training Set: Not applicable/not provided (no AI/algorithm training mentioned).
• How Ground Truth for Training Set was Established: Not applicable/not provided.

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