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The illumiflow 148 Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila to V or females with androgenic alopecia who have Ludwig-Savin Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV

Similar to the original illumiflow 272 Laser Cap and the predicate LaserCap 120, the modified illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers operating at 650 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.

The illumiflow 148 Laser Cap utilizes 148 laser diodes to deliver laser stimulation to the scalp. The device is operated via a single button on the battery pack, and has an audible timer that automatically turns the lasers off after a 30-minute treatment session.

Here's an analysis of the provided text regarding the illumiflow 148 Laser Cap, addressing your questions about acceptance criteria and study proving device performance:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or new safety profiles. Therefore, some of the information you requested, particularly those related to detailed clinical study design (like MRMC studies, specific sample sizes for test/training sets in a clinical trial context, and ground truth establishment for clinical data), is either not present or is addressed in the context of equivalence to previously cleared devices.

Acceptance Criteria and Device Performance (Context of 510(k) - Substantial Equivalence)

For a 510(k) submission like this, "acceptance criteria" are not typically framed as specific performance metrics in a clinical study to prove de novo efficacy, but rather as demonstrations that the device is as safe and effective as a predicate device. The performance is assessed against the predicate's known safety and efficacy profile through non-clinical testing and comparison of technological characteristics.

Here's the closest interpretation of your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria" in this context: The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. The device "meets the acceptance criteria" if the FDA agrees it is substantially equivalent in terms of indications for use, technological characteristics, and safety and effectiveness. The "reported device performance" here describes how the new device compares to its predicates on key characteristics.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not applicable in the context of a clinical test set as described for an AI/diagnostic device. This submission relies on non-clinical bench testing and comparison to predicates. The non-clinical testing performed includes electrical safety, laser classification, battery, and home use standards. There are no "patient samples" or "data sets" in the conventional sense for performance validation of a diagnostic algorithm.
• Data Provenance: The data comes from internal EGlobal, LLC testing (bench testing, risk analysis, mathematical calculations) and comparison with previously cleared predicate devices (illumiflow 272 Laser Cap and LaserCap 120). It is not clinical data from patients or specific countries. The testing is retrospective in the sense that it's performed after the device design is finalized, but not on a historical patient cohort.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. There was no ground truth for a clinical test set established by experts in the context of this 510(k) submission, as it was not a clinical trial to prove efficacy with a new mechanism of action or for a new indication. The basis for safety and efficacy is comparison to predicate devices, which would have undergone their own prior evaluations (though not detailed here).

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set with human subject data requiring adjudication was described or used for this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This device is a low-level laser therapy device for hair growth, not an AI-assisted diagnostic tool where human readers interpret images. Therefore, the concept of human reader improvement with AI assistance is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This is a hardware device (laser cap), not an algorithm or software. Its performance is inherent in its physical and electrical characteristics and energy delivery, not in an independent algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this 510(k) is the established safety and efficacy profile of the predicate devices cleared by the FDA for the same intended use. The submission aims to show that the new device is "substantially equivalent" and therefore can be considered safe and effective for the same indications as the predicates, without requiring new clinical trials to re-establish efficacy.
• The "truth" for the non-clinical performance tests is based on engineering standards (e.g., IEC standards for electrical safety, laser classification, etc.).

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As above, no training set was used.

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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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