(82 days)
The Capillus272 Pro, Capillus82 OfficePro, Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V ; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.
The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (capillus272 Pro) and clinical office use (Capillus272 OfficePro). The Capillus82 and Capillus202 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are 82 and 202 respectively. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.
The provided text is a 510(k) summary for medical devices (Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202) intended for hair growth promotion. It does not contain a detailed report of a study with specific acceptance criteria and performance data in the format typically used for diagnostic or AI-based devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and the general understanding of Low-Level Laser/Light Therapy (LLLT) efficacy.
However, I can extract the relevant information from the document to construct an answer based on the intent of your questions, even if some points are addressed by referencing prior submissions or common knowledge about LLLT.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria related to efficacy (e.g., specific percentage increase in hair count) for this specific submission. Instead, it relies on the established efficacy of LLLT for androgenic alopecia and compliance with safety standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Referenced) |
|---|---|
| Safety: Compliance with recognized international standards for laser safety. | The Capillus272 OfficePro, Capillus82, and Capillus202 conform to the standard IEC-602825-2007-03. This establishes the AEL (accessible emission limits) as 5 milliWatts maximum for Class 3R lasers. The charger conforms to IEC 60950. The devices are classified as Class 3R laser systems. "There have been no reported safety issues with any LLLT device to date." "All compliant LLLT systems which use red light diode lasers are classified as class 3R laser systems according to the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same." "no new safety or efficacy concerns are raised due to the minor differences present between devices." |
| Efficacy (Substantial Equivalence): Promotion of hair growth in specified populations, comparable to predicate devices. | The document asserts that "Capillus is certain that the difference in the physical appearance, number of diodes, or in the method of delivering the radiant energy of the systems is of no consequence and does not affect the therapeutic value or the safety profile." It explicitly states that "The Capillus272 Pro, Capillus82 and Capillus82 and Capillus202 are as safe and effective as the predicate devices, iGrow and HairMax LaserBand, as well as other reference devices in its class, such as the Hairmax LaserComb." The comparative table lists "Efficacy Rates - High Compared to Placebo" for Capillus devices, referencing "Efficacy Rates - 34-41%" for iGrow and "Trial results are all significant increase with respect to placebo" for HairMax LaserBand. It also states, "the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia in both genders". The expansion of use for males is considered "reasonable and consistent with the known uses attributed to LLLT devices in general" given iGrow demonstrated equivalence between genders and HairMax proved the non-gender-bias concept. |
| Performance Data: Compliance with design specifications. | "Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criteria were met by the device." (Note: This is a general statement and not specific quantitative performance data for hair growth). |
2. Sample size used for the test set and the data provenance
The document does not describe a new clinical study with a "test set" for this specific 510(k) submission. The submission relies on the established efficacy of LLLT devices in general and predicate devices. Therefore, there is no information on a specific sample size or data provenance (country, retrospective/prospective) for a new test set in this document. The efficacy claims are derived from prior studies of predicate and reference devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no new clinical study with a "test set" is detailed in this submission, there is no mention of experts forming a ground truth for such a set. The overall acceptance of LLLT as a viable modality is based on broader scientific consensus and regulatory approvals.
4. Adjudication method for the test set
Not applicable, for the same reasons as #3.
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
Not applicable. This device is a low-level laser therapy device for hair growth, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the device's intended effect (hair growth promotion) is based on:
- Clinical trial results of predicate and reference devices: The document refers to efficacy rates (e.g., 34-41% increase compared to placebo for iGrow, significant increase for HairMax LaserBand) from studies supporting the clearance of those devices.
- Scientific and Medical Consensus: The statement "the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia" implies a broader acceptance based on accumulated evidence.
- Absence of reported adverse events: "There have been no reported safety issues with any LLLT device to date."
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "training" in this context would be the cumulative clinical evidence for LLLT technology.
9. How the ground truth for the training set was established
Not applicable. For the reasons stated in #8.
§ 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.