(234 days)
The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.
The PBM Hair Therapy Cap is a hair therapy device that uses red light to help stimulate hair growth in both male and females. The device comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits the user to 15-minute sessions. The device uses only 660nm LED wavelength diodes on 7 strips, each strip has 12 diodes. These diodes strips are sewn into a cap and has a Type C USB connector that the controller battery pack can connect to. The PBM Hair Therapy Cap is comprised of a fabric cap with inbuilt LED diodes that emit red light on the wavelength of 660nm. The diodes are on strips and the cap style hat has 7 strips with 12 diodes on each strip with a total of 84 LED diodes. A battery powered controller that attaches via a C-type USB connector to the fabric hat is also provided. The controller has a built in 3.7V lithium-ion battery, has an on/off button and in programmed to automatically turn of after 15min of use. The controller also has a 2 small indicator LED's for indicating, power on/in use, needs charging and also blinks while in charging mode. The controller charges via inbuilt C-Type USB port and charges at 500 mA.
The provided documentation is a 510(k) premarket notification summary for the PBM Hair Therapy Cap. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical study with specific acceptance criteria, and detailed performance metrics to prove direct efficacy of the new device.
Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study design details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance, training set details), and statistical proof of meeting those criteria is not present in this type of FDA submission.
Instead, the document makes a comparison between the PBM Hair Therapy Cap and a predicate device (Revian Red) based on intended use, technological characteristics, and safety profiles.
Here's a breakdown of what can be extracted from the document in relation to your request, and what is explicitly stated as "Not Applicable" or absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document as it's a substantial equivalence submission, not a direct clinical efficacy study for the new device. The document asserts "substantially equivalent" rather than meeting pre-defined acceptance criteria for performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As explained above, this is not a new clinical efficacy study.
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 provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
There is no mention of an MRMC study. The device is a "Hair Therapy Cap" that uses light, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical light therapy cap, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The submission relies on demonstrating similarity to a previously cleared device.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" in the context of an AI/ML algorithm for this device.
9. How the ground truth for the training set was established
This information is not applicable.
Summary of available information related to equivalence:
- Predicate Device: Revian Red (K173729)
- Basis for Equivalence:
- Intended Use/Indications for Use: The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females (Ludwig-Savin Scale I to II) and males (Norwood Hamilton Classifications of IIa to V), both with Fitzpatrick Skin Types I to IV. This is stated to be substantially equivalent to the predicate, "just worded slightly differently."
- Technological Characteristics: Both devices utilize LLLT (Low-Level Laser Therapy) mechanism of action with textile hair growth on the scalp.
- Similarities: Use 660nm LED wavelength.
- Minor Differences (considered negligible and not affecting therapeutic value or safety):
- Battery types (lithium polymer in predicate vs. 3.7V lithium-ion in PBM Hair Therapy Cap).
- Wavelengths (both 660nm, but the statement implies the predicate might have a range while the PBM is specifically 660nm).
- Number of Red LEDs (PBM: 84 diodes; Predicate: 119 Red LEDs).
- Treatment durations (PBM: 15 minutes; Predicate: 10 minutes).
- Safety Profile: Both devices are classified as class 3R laser systems in accordance with IEC standards and share a substantially equivalent adverse event profile.
- Non-Clinical Tests: "Verification of requirements (VR0001) and usability testing (US001, in accordance with IEC 62366-1:2015 and Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff)." These are generally about meeting engineering specifications and usability standards, not clinical efficacy trials.
- Conclusion: The totality of non-clinical data provides valid scientific evidence to support the conclusion that there are no different questions of safety and effectiveness raised when compared to the predicate device. This data demonstrates the PBM Hair Therapy Cap is substantially equivalent to the predicate Revian Red based upon the totality of the evidence.
§ 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.