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Lumena FH is an over the counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Lumena FH is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Over-The-Counter, AC Powered, Personal Light-Based Hair Removal System. Emission activation is by fingerswitch. Device includes a limited life lamp cartridge. Overall weight of the device is 1.0 Kg, and the size is 22 x 16 x 78 cm (HxWxD). The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A single phase.

The Shaser Lumena FH Hair Removal System (K140631) is an over-the-counter device intended for the removal and permanent reduction of unwanted hair in adults with Fitzpatrick skin types I-IV.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Label comprehension: 150 study subjects.
  • Usability test: 123 study subjects.
• Data Provenance: The document does not explicitly state the country of origin, but given the FDA submission, it is likely that the study subjects were from the United States. The study appears to be prospective as it involved testing subjects for comprehension and usability.

3. Number of Experts and Qualifications for Ground Truth

The document does not detail the use of experts to establish ground truth for this device's performance in hair removal. The "ground truth" here seems to be the participants' ability to comprehend instructions and use the device safely and appropriately, rather than a clinical outcome measured by experts.

4. Adjudication Method

The document does not describe any adjudication method. For label comprehension and usability tests, adjudication typically isn't applied in the same way as clinical outcome assessments. The "results of the two tests confirm sufficient label comprehension and safe and appropriate use" implies a pass/fail or statistical analysis of the subjects' performance.

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

No MRMC comparative effectiveness study was mentioned. The study focused on label comprehension and device usability by consumers, not on comparing human readers' performance with and without AI assistance for hair removal assessment. This device is a hair removal system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical light-based hair removal system, not an algorithm. The "performance data" refers to its safety and usability when operated by a human user.

7. Type of Ground Truth Used

The ground truth for the clinical performance data (label comprehension and usability) was based on direct observation and assessment of study subjects' ability to understand instructions and safely operate the device. This is not expert consensus, pathology, or outcomes data in the traditional medical device sense, but rather a behavioral and functional assessment. For the "permanent reduction in unwanted hair" claim, the predicate device's efficacy, measured at 6, 9, and 12 months, serves as the benchmark, implying an outcomes-based ground truth for hair reduction itself, but the current submission focuses on equivalence in safety and usability for the new device.

8. Sample Size for the Training Set

The document does not mention a training set. The clinical performance data presented refers to the evaluation of the device itself (usability and label comprehension), not the training of an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set or algorithm is mentioned.

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