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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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The Beurer 5500 IPL Device is an over the counter device intended for the removal of unwanted body and/ or facial hair in adults. The Beurer 5500 IPL Device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The Beurer IPL 5500 device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Beurer IPL 5500 device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Beurer IPL 5500 device is 3 cm². The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the Beurer IPL 5500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the Beurer IPL 5500 device will not trigger a pulse.

This document is a 510(k) premarket notification for the Beurer IPL 5500 hair removal device. It aims to demonstrate substantial equivalence to previously cleared devices. It does not contain the detailed information typically found in a clinical study report that would directly address acceptance criteria, human reader performance, or specific ground truth methodologies in the way an AI/ML device submission would.

Therefore, many of the requested items (e.g., number of experts, adjudication methods, MRMC study, training set details) are not applicable to this type of submission for a non-AI/ML medical device. The focus here is on demonstrating safety and efficacy through equivalence to existing devices and compliance with recognized standards.

Here's an analysis of what information can be extracted relevant to the spirit of your questions, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" for clinical performance in the way an AI/ML device would, because it's relying on substantial equivalence to predicate devices, not demonstrating novel clinical efficacy through a new study with specific performance metrics.

Instead, the "performance" is demonstrated through:

• Technological Characteristics Comparison (Section 6): Showing that the Beurer IPL 5500 device operates on the same principles and largely the same parameters as predicate devices.
  • Wavelength: Beurer IPL 5500 (475-1200nm) vs. sensiLight mini (475-1200nm) vs. Duo (480-1200nm). Acceptance: Same or very similar spectrum. Performance: Met.
  • Fluence/Flux: Beurer IPL 5500 (5 J/cm²) vs. predicate devices (5 J/cm²). Acceptance: Exactly the same maximum energy. Performance: Met.
  • Pulse Duration: Beurer IPL 5500 (same as sensiLight mini, similar to Duo). Acceptance: Same/similar. Performance: Met.
• Bench and Safety Testing (Section 7): Compliance with recognized standards.
  • Acceptance: Compliance with various IEC, ISO, and FCC standards.
  • Performance: The document states "has been successfully tested through bench and safety tests" and "complies with the following voluntary recognized standards." Specific results/values are not provided in this summary, but the claim is that they met the standards.

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

• Sample Size: Not applicable. This submission does not describe a new clinical study with a "test set" of patients for performance evaluation in the way an AI/ML device would. It relies on the prior clearance of predicate devices and bench testing.
• Data Provenance: Not applicable for a new clinical study. The "data" driving the clearance is the established safety and efficacy of the predicate devices and the results of bench tests on the new device.

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

• Not applicable. There was no new clinical study with a "test set" requiring ground truth establishment by experts for performance assessment.

4. Adjudication Method for the Test Set:

• Not applicable. There was no new clinical study with a "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done & Effect Size:

• No. This is not an AI/ML device, and no MRMC study was performed or needed for this type of 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

• Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:

• For the intended use and clinical claims (permanent hair reduction), the "ground truth" for predicate devices would have been clinical outcomes data (measured hair reduction at 6, 9, 12 months).
• For the current device's submission, the "ground truth" for demonstrating safety and equivalence is bench test results following established engineering and medical device standards.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device using a "training set."

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

• Not applicable. This is not an AI/ML device.

Summary of what's present in the document:

The submission focuses heavily on substantial equivalence to predicate devices (EL Global Trade Ltd.'s sensiLight Mini and Stetic Medical Aesthetics Development's Duo IPL-HH380-IT) based on:

• Similar indications for use (hair removal, permanent hair reduction).
• Same technology (Intense Pulsed Light - IPL).
• Comparable technological characteristics (wavelength spectrum, fluence/flux, pulse duration).
• Similar design and components.
• Identical safety features (skin proximity sensor, skin pigmentation sensor).
• Extensive bench and safety testing to recognized standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, FCC part 15, IEC 60601-1-2, IEC 62471, IEC 62304 for software, ISO 10993-1 for biocompatibility, ISO/IEC 14971 for risk management). The document states "Tests results are supporting all labeling claims in order to establish substantial equivalency."

"No new clinical performance data is reported in this submission" (Section 8) explicitly states that the submission did not conduct a new clinical study to directly prove efficacy, but rather relied on the equivalence to devices that already demonstrated it.

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