(140 days)
The HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are indicated to treat androgenetic alopecia, promote hair growth and help prevent further hair loss in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV.
Substantially equivalent to the HairMax LaserComb (K060305, K093499), the modified HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are handheld low level laser devices that emits laser light with the intention to promote hair growth. The devices provide distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 replace the cleared version's single beam laser and beam splitting reflector with a circuit board containing seven, nine, or twelve laser diodes. respectively.
The provided text describes clinical trials for the HairMax LaserComb devices, but it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria, especially for an AI/CADe device. The information is geared towards establishing substantial equivalence to previously cleared devices.
However, I will extract the information that is present and highlight what is missing based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for a new device's performance metrics (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness. The reported performance relates to the effect of the device rather than specific diagnostic or analytical metrics.
| Acceptance Criteria | Reported Device Performance (from multi-center clinical trials) |
|---|---|
| Safety: Device adheres to electrical and EMC safety requirements. | Confirmed adherence to IEC 60601-1 and 60601-1-2. |
| Laser Classification: Laser classification is Class 3R. | Confirmed adherence to IEC 60825 (Class 3R). |
| Effectiveness: Promote hair growth in males with androgenetic alopecia (Norwood-Hamilton IIa-V, Fitzpatrick I-IV). | Expected to provide an effective dose rate to promote hair growth. |
| Effectiveness: Prevent further hair loss in males with androgenetic alopecia (Norwood-Hamilton IIa-V, Fitzpatrick I-IV). | Expected to help prevent further hair loss. |
| Overall substantial equivalence (Safety & Effectiveness): Compared to predicate devices (K060305, K093499). | Safety and effectiveness outcomes substantially equivalent to predicate devices. |
| Usability: User manual is validated, and device modifications do not affect safe and effective use. | Device and manual validated within a sample population. Modifications do not affect safe and effective use compared to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Two randomized, double-blind, controlled, multi-center clinical trials" were conducted.
- Test Set Sample Size: The exact sample size for these clinical trials is not provided in the given text.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: "randomized, double-blind, controlled, multi-center clinical trials" are inherently prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. The studies evaluated changes in "terminal hair-count in the evaluation zone," which implies objective measurement rather than expert consensus on a diagnostic image.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with vs. without AI assistance was not done, nor would it be relevant for this type of device. The HairMax LaserComb is a therapeutic device, not an AI/CADe diagnostic tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The HairMax LaserComb is a physical therapeutic device, not an algorithm. Its performance is assessed as a standalone device used by a human, but there is no "algorithm only" performance to evaluate in this context. The clinical trials evaluated the device's effect on hair growth in patients.
7. The Type of Ground Truth Used
The ground truth used in the clinical trials was likely based on objective measurements of hair growth (e.g., changes in terminal hair count, possibly photographic assessment, or other standardized dermatological metrics to assess hair density and growth). The document mentions "evaluating changes in terminal hair-count in the evaluation zone." This falls under outcomes data or objective clinical measurements.
8. The Sample Size for the Training Set
This question is not applicable in the context of the provided text. The HairMax LaserComb is a physical medical device, not an AI/ML algorithm that requires a "training set." The clinical trials served as the verification and validation studies for the device's performance.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
§ 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.