(22 days)
The Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
The Capillus302, Capillus312, and Capillus352 consist of 302, 312, or 352 (respectively) red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. These models are exactly the same as the (predicate) Capillus family of devices (Capillus272, Capillus202, Capillus82) with the exception of the number of diodes.
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.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance to design specifications; all functions operate as designed. | "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." |
| Conformity to IEC-602825-2007-03 standard for laser class 3R (AEL = 5mW max) | "The Capillus302, Capillus352 conform to the standard IEC-602825-2007-03. This IEC standard is a recognized and accepted standard by the FDA. ... This report validates for the Capillus312, and Capillus352 the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum." |
| Charger conforms to IEC 61959. | "The charger conforms to IEC 61959." |
| No new safety concerns compared to predicate devices. | "Just as for Capillus family of devices (K160285), there are no reported adverse events for this technology." (Implies no unexpected adverse events, consistent with predicate). "Additionally, no new safety or efficacy concerns are raised due to the minor differences present between devices." |
| Comparable efficacy to predicate devices (specifically for the Capillus family of devices - K160285: "Efficacy Rates - High Compared to Placebo"). | The document states "Efficacy Rates – 51% (calculated)" for the candidate devices (Capillus 302, 312, 352) and "Efficacy Rates - High Compared to Placebo" for the predicate Capillus family of devices (K160285). While a direct comparison or statistical equivalence is not performed or reported in this summary, the statement "no new safety or efficacy concerns are raised due to the minor differences present between devices" suggests the sponsor considers the efficacy comparable or acceptable given the context of substantial equivalence to existing devices. The 51% calculated efficacy in the table appears to be a reported performance metric rather than a specific acceptance criterion for the current submission, but it's presented as part of the comparison. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not detail a specific clinical test set with a sample size for the Capillus302, Capillus312, and Capillus352 devices. The "Performance Data" section primarily discusses compliance to design specifications and recognized standards.
The efficacy rate of "51% (calculated)" is listed in the comparison table for the candidate devices. However, the accompanying text does not describe this as coming from a new clinical study for these specific models. Given the context of a 510(k) where the new devices are considered substantially equivalent to existing cleared devices with minor changes (number of diodes), it's highly probable that the "51% (calculated)" efficacy rate, if from a study, would stem from an earlier study that contributed to the predicate device's clearance and is being referenced here to support the equivalence claim.
Therefore, the sample size and data provenance for a test set specific to these exact models for efficacy are not explicitly provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since a dedicated clinical test set for these specific models (Capillus302, 312, 352) to establish new efficacy data is not described in the provided text, there is no information on experts, their number, or qualifications used to establish ground truth for such a test set.
4. Adjudication Method for the Test Set
As no specific test set for the current models is detailed for efficacy, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on technological characteristics and substantial equivalence to previously cleared devices.
6. Standalone (Algorithm Only) Performance Study
These devices are hardware-based laser caps for hair growth, not algorithms or AI. Therefore, a "standalone algorithm-only performance study" is not applicable and not mentioned.
7. Type of Ground Truth Used
For the efficacy claim (if the "51% calculated" refers to a study), the ground truth for hair growth studies typically involves objective measurements like hair count (total, terminal, vellus), hair density, and sometimes photographic assessment by experts, or patient/physician global assessment. However, the document does not explicitly state the type of ground truth used for the "51% (calculated) efficacy rate" beyond the implication that it's related to hair growth. Given the context of Low-Level Laser Therapy (LLLT) for androgenetic alopecia, hair count metrics are common.
8. Sample Size for the Training Set
Since these devices are hardware-based and not AI/ML algorithms, the concept of a "training set" in the context of machine learning is not applicable here. The document does not describe AI development.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" for an AI/ML algorithm is not applicable.
§ 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.