(346 days)
The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.
The LaserComb consists of a hand-held low level laser device that promotes hair growth. The device provides 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. When in use, the device emits a beep every four seconds to notify the user to move the device to a new section of the scalp.
Here's a breakdown of the acceptance criteria and the study details for the Lexington International, LLC LaserComb, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the clinical study's findings regarding the device's ability to promote hair growth and its safety profile.
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Efficacy | Significant increase in mean terminal hair density | Subjects in the LaserComb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. |
| Significant improvement in overall hair regrowth (subjective) | Subjects in the LaserComb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. | |
| Safety | No serious adverse events | No subject experienced a serious adverse event. |
| Adverse event profiles similar to placebo | The adverse event profiles were similar between the two treatment groups. | |
| Functionality | Device functions as intended for proposed indication | In all instances, the LaserComb functioned as intended. |
| Hair regrowth as expected | The hair regrowth observed was as expected. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a single number. The document refers to "subjects" in a multicenter clinical trial. To provide a precise number, further details from the full clinical study report would be needed. However, it was a "multicenter" trial, indicating a reasonable sample size across multiple locations.
- Data Provenance:
- Country of Origin: United States ("conducted at four sites in the United States").
- Retrospective or Prospective: Prospective (clinical trial where subjects were enrolled and followed over time).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set in the context of image analysis or diagnostic interpretation. The ground truth for efficacy was objectively measured (mean terminal hair density) and subjectively assessed by the subjects themselves (overall hair regrowth). For safety, adverse events were monitored.
4. Adjudication Method for the Test Set
Not applicable. The study design was a randomized, placebo-controlled trial. Efficacy endpoints were objective measurements (hair density) and subjective assessments by the subjects, not requiring expert adjudication of "ground truth" in the diagnostic sense. Safety endpoints involved adverse event reporting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating cases with and without AI assistance to measure improvement in diagnostic performance. The LaserComb study focused on the direct physiological effect (hair growth) of the device versus a placebo, not on assisting human interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone study was done. The clinical trial evaluated the LaserComb device itself (algorithm/device only) in the treatment group compared to a sham device (placebo group). There was no "human-in-the-loop" component where the device was assisting a human operator in making a decision. The device directly delivers the therapeutic intervention.
7. Type of Ground Truth Used
The ground truth used for efficacy was:
- Objective Measurement: Mean terminal hair density. This is a direct, quantifiable biological change.
- Subjective Assessment: Subjects' self-assessment of overall hair regrowth.
For safety, the ground truth was based on reported adverse events.
8. Sample Size for the Training Set
Not applicable/not provided. This device is a therapeutic device, not an AI algorithm that requires a separate "training set" for model development. The clinical study serves as the primary validation of its efficacy and safety.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm developer. The device's mechanism is based on low-level laser therapy, and its performance (efficacy and safety) was established through the described clinical trial.
§ 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.