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The IPL 8500 device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. IPL 8500 is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of treatment regimen.

The Beurer IPL 8500 device is an intense pulse light hair reduction device. Phototherapy (Light-based) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Beurer IPL 8500 device is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Beurer IPL 8500 device is 4.5 cm² or 2 cm2 (for large and precise treatment windows, respectively).

The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Beurer IPL 8500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.

Here's a breakdown of the acceptance criteria and study information for the Beurer IPL 8500 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Labeling Comprehension/Self-Selection Study:
  • Sample Size: 25 participants (4 men, 21 women)
  • Data Provenance: Not explicitly stated, but likely prospective, as participants were "enrolled to this study" and received labeling materials to evaluate. The study was conducted for the purpose of this submission.
• Usability/User Interface Study:
  • Sample Size: Not explicitly stated for all tasks, but "all tasks were completed by 100% of the participants" implies the same 25 participants were involved. The follow-up satisfaction questionnaire had 18 participants.
  • Data Provenance: Not explicitly stated, but likely prospective, as participants performed tasks with the device and provided feedback.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Labeling Comprehension/Self-Selection Study:
  • Number of Experts: 1 moderator ("k=1")
  • Qualifications: Not explicitly stated. The moderator's role was to further validate the correct answers given by participants, suggesting they had expertise in the device's labeling and intended use.

4. Adjudication Method for the Test Set

• Labeling Comprehension/Self-Selection Study: The "moderator (k=1)" validated the correct answers given by participants. This implies a direct validation method by a single expert rather than a consensus or multi-expert adjudication.
• Usability/User Interface Study: No explicit adjudication method described beyond the direct observation of participants completing tasks.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The studies described are human factors validation studies focused on user comprehension and usability, not on comparing reader (human) effectiveness with and without AI assistance for a diagnostic or treatment outcome.

6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done

• This device is an IPL hair removal device, not an AI/algorithm-driven diagnostic or treatment recommendation system in the typical sense where "standalone performance" refers to the algorithm's accuracy. The device has embedded software and sensors (skin proximity, pigmentation sensor), and software validation was done (IEC 62304). However, the performance data presented primarily focuses on the electrical, mechanical, photobiological safety, and human factors validation of the device-user interaction, rather than an AI algorithm's standalone performance.

7. The Type of Ground Truth Used

• Human Factors Validation (Labeling Comprehension/Self-Selection): The "correct answers" regarding intended use, treatment areas, and contraindications, as validated by the moderator. This is essentially an expert-defined ground truth based on the device's labeling.
• Human Factors Validation (Usability/User Interface): Successful completion of predefined tasks according to instructions. This is an objective ground truth based on whether the user physically and correctly performs the steps outlined in the labeling.

8. The Sample Size for the Training Set

• Not applicable. The document does not describe any machine learning or AI models with distinct "training sets." The "Beurer IPL 8500 device" itself is being validated, not an algorithm trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no described training set for an AI model.

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