(57 days)
The HairMax Dual 12 is indicated to Treat Androgenetic Alopecia and Promote Hair Growth in Females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal and Fitzpatrick Skin Types I to IV.
Substantially equivalent to the HairMax Pro 12 (K103368) and HairMax Lux 9 for females (K110233), the HairMax Dual 12 is a hand-held low-level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure maximum laser light reaches the user's scalp. HairMax Dual 12 utilizes twelve laser modules, six with wavelengths of 655nm and six with wavelengths of 635nm with the same exact output power as the HairMax Pro 12.
The HairMax Dual 12 is a hand-held low-level laser device intended to treat Androgenetic Alopecia and promote hair growth in females with specific Ludwig (Savin) and Fitzpatrick Skin Types.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Significant increase in hair count | 16 weeks: 81% of subjects experienced increases in hair count (minimum 5 new hairs) |
| 26 weeks: 95% of subjects experienced significant increases in hair count (minimum 5 new hairs) | |
| Safety Endpoint: No serious adverse events | No subjects experienced any serious adverse event from the treatments. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the "test set" in terms of how many subjects were in the treatment group versus a control group for the specific device validation. However, it mentions a clinical trial.
- Sample Size: The document does not provide the precise number of subjects in the clinical trial. It states "The study population included females between the ages of 25 to 60 years with a diagnosis of androgenetic alopecia..."
- Data Provenance: The study was a "randomized, double-blind, controlled, multi-center clinical trial" conducted at 3 sites:
- Cleveland Clinic - Wilma Bergfeld M.D.
- University of Minnesota - Maria Hordinsky M.D.
- University of Miami - Lawrence Schachner M.D.
This indicates prospective data collection from multiple centers within the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth, such as for hair counting. However, the principal investigators at each clinical trial site were:
- Wilma Bergfeld M.D. (Cleveland Clinic)
- Maria Hordinsky M.D. (University of Minnesota)
- Lawrence Schachner M.D. (University of Miami)
It can be inferred that these medical doctors, likely dermatologists or experts in hair and skin conditions, would have overseen or participated in the assessment of hair count.
4. Adjudication Method for the Test Set
The document states "It is difficult to count hairs on darker skin tones" implying visual assessment. It doesn't explicitly mention a specific adjudication method like 2+1 or 3+1 for hair counting. The study was "double-blind," meaning neither the subjects nor the researchers administering the treatment (and presumably collecting some data) knew whether the subjects were receiving the active device or a placebo. The phrasing "based on a minimum of 5 new hairs being observed at follow up" suggests a direct observation method. No specific adjudication protocol for discrepancies in hair counting is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a clinical trial evaluating the device's effectiveness, but it does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how human readers improve with AI assistance versus without AI assistance. The device is a direct treatment device, not an AI-based diagnostic or assistive tool for human readers.
6. Standalone Performance
Yes, a standalone study was done. The clinical trial directly evaluated the "performance of the HairMax Dual 12 to treat androgenetic alopecia and promote hair growth in females." The reported performance metrics (81% and 95% of subjects experiencing increased hair count) are based on the device's direct application and its effect on study participants, without human intervention in interpreting results or making diagnoses based on AI output.
7. Type of Ground Truth Used
The ground truth used was changes in hair count observed directly on the scalp of participants in the clinical trial. This is a direct observational outcome.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI. This device is a physical medical device, not a software algorithm that requires a training set for machine learning. The clinical trial served as the and only performance evaluation for the device.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there is no mention of a training set as this is a physical device, not an AI/ML algorithm.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.