(126 days)
Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
Laser Therapy Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. 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. Lasercomb-001 contains 7 laser diodes, and Lasercomb-002 contains 9 laser diodes.
Here's an analysis of the provided FDA 510(k) summary, specifically addressing the acceptance criteria and supporting studies for the Laser Therapy Hair Growth Comb.
It's important to note that this document is a 510(k) summary for a medical device and typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving independent effectiveness through a novel clinical trial with pre-defined acceptance criteria for performance metrics like sensitivity or specificity. The "acceptance criteria" in this context refer to demonstrating equivalence in safety and fundamental operating characteristics.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this 510(k) submission are not explicitly stated as numerical performance targets (e.g., "sensitivity must be >X%"). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and safety/performance standards. The reported device performance is primarily confirmed through adherence to recognized electrical safety, EMC, and biocompatibility standards, and by matching the technical specifications of the predicate devices.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: | The Laser Therapy Hair Growth Comb (models Lasercomb-001 & Lasercomb-002) shares the same intended use: to treat Androgenetic Alopecia and promote hair growth in specific populations (females with Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss; males with Norwood Hamilton Classifications of IIa to V; both with Fitzpatrick Skin Types I to IV) as the predicate devices (HairMax LaserComb Advanced 7 - K103368 & K112524, and HairMax LaserComb Lux 9 - K110233). |
| Technological Characteristics Equivalence: | The device's technological characteristics (Type of laser, Wavelength, Amount of laser diodes, Energy per laser diode, Classification according to IEC60825-1, Treatment time, Treatment frequency, Applicable people, Applicable skin, Shape design) are either identical to or within acceptable variations of the predicate devices. For instance, both the subject device and predicates use visible red light-emitting diodes at 650nm ± 10nm. The number of diodes (7 for -001, 9 for -002) matches the respective predicate models. |
| Safety and EMC Performance: | Complies with IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-11 (home healthcare environment), IEC 60601-1-2 (electromagnetic compatibility), and IEC 60825-1 (laser safety). The battery conforms to IEC 62133. These are the same standards met by the predicate devices. |
| Biocompatibility: | All body-contacting materials comply with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization), and ISO 10993-23 (irritation). These are the same standards met by the predicate devices. |
| Clinical Performance Equivalence: | The submission concludes that "Laser Therapy Hair Growth Comb was found to have a safety and effectiveness profile that is same as the predicate device," based on the comparative analysis of intended use, design, materials, and performance (safety data). This implies that since the predicate device was shown to be effective, and the subject device is substantially equivalent, its effectiveness is inferred. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any clinical test set or patient data (retrospective or prospective) used to directly assess the performance of the subject device the "Laser Therapy Hair Growth Comb" for its primary intended use (treating alopecia and promoting hair growth).
The performance data provided (biocompatibility, electrical/EMC safety) are results from laboratory testing of the device components and system, not clinical trials on patients. The "sample size" for these tests would refer to the number of device units or material samples tested, not a patient population.
The clinical effectiveness claimed for the subject device is established by its substantial equivalence to predicate devices that presumably had clinical data supporting their original clearance. This document does not detail the clinical studies of the predicate devices. Therefore, there's no information on a specific test set, sample size, or data provenance relevant to the subject device's clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as no clinical test set for performance (e.g., hair growth assessment) of the subject device is described in this 510(k) summary. The "ground truth" for the technical safety and biocompatibility tests is established by recognized international standards (IEC, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set requiring expert adjudication for a ground truth is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a "Laser Therapy Hair Growth Comb," which is a direct treatment device, not an AI-powered diagnostic or assistive tool for human interpretation. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical therapeutic product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical and safety performance data provided:
- Safety (Electrical & EMC): Ground truth is defined by compliance with specified international standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60825-1, IEC 62133). Testing against these standards determines compliance.
- Biocompatibility: Ground truth is defined by compliance with specified international standards (ISO 10993-5, ISO 10993-10, ISO 10993-23). Laboratory tests are conducted to assess cell viability, irritation, and sensitization effects.
For the clinical effectiveness as argued for substantial equivalence, the ground truth would have been established by clinical studies of the predicate devices (HairMax LaserComb models), likely involving:
- Outcomes data: Objective measurements of hair count, hair density, hair thickness, or photographic assessments over a specified treatment period.
- Expert assessment: Dermatologists or trichologists assessing the degree of hair loss and improvement.
- (Potentially) Patient reported outcomes: Surveys or questionnaires on perceived hair growth and satisfaction.
However, details about these ground truth methods for the predicate devices are not provided in this specific summary.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not an AI algorithm that requires a training set in the machine learning sense. The manufacturing processes and quality control systems might involve historical data, but not a "training set" for AI.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for the device in the context of AI/machine learning.
§ 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.