(77 days)
The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.
The Capillus82 consists of 82 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.
The provided document is a 510(k) summary for the Capillus 82 device, which is indicated for promoting hair growth in females with androgenic alopecia. This document asserts substantial equivalence to a predicate device (Capillus 272 Pro) and other reference devices, rather than presenting a new study for the Capillus 82 that establishes its own acceptance criteria and performance against those criteria.
Therefore, the following information is not directly available from the provided text for the Capillus 82:
- A new table of acceptance criteria and reported device performance from a new study for the Capillus 82. Instead, the document argues that the Capillus 82 meets the same safety and efficacy profiles as its predicate device due to similar technology and reduced "dose."
- Sample sizes used for testing.
- Data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth from a new study.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm-only performance study (as this is a physical device, not an AI algorithm).
- Details on the sample size for the training set or how ground truth was established for a training set (again, not an AI algorithm context).
However, the document does provide information that relates to performance and criteria through its comparison to predicate devices and adherence to existing standards. I can extract this information and present it in a way that addresses your request where possible, clarifying when the information refers to the predicate device or general standards rather than a new study for the Capillus 82.
Here's a breakdown of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" for a new study of the Capillus 82 itself. Instead, it claims substantial equivalence based on the technological characteristics and conformity to standards. The closest representation of "performance" relates to its intended use and efficacy, which is inferred to be similar to predicate devices, albeit with potentially slower results due to fewer diodes.
| Criteria Category (Inferred) | Predicate Device (Capillus 272 Pro) Performance | Capillus 82 Performance (Claimed) |
|---|---|---|
| Intended Use / Efficacy | Promotes hair growth in females with androgenic alopecia (Ludwig-Savin Class I-II, Fitzpatrick Skin Phototypes I-IV). Efficacy Rates: High Compared to Placebo. | Promotes hair growth in females with androgenic alopecia (Ludwig-Savin Class I-II, Fitzpatrick Skin Phototypes I-IV). Expected to affect efficacy (slower) due to reduced number of lasers/total "dose" compared to Capillus 272 Pro, but accepted due to indefinite treatment and lower cost. Claims "as effective" commensurate to number of diodes. |
| Safety - Laser Classification | Class 3R (IEC-60825-2007-03) | Class 3R (IEC-60825-2007-03). AEL (accessible emission limits) 5 milliWatts maximum. |
| Safety - Adverse Events | No reported adverse events | No reported adverse events for this technology (inferred for Capillus 82 based on Capillus 272 Pro and reference devices) |
| Technological Characteristics - Laser Wavelength | 650 nm | 650 nm |
| Technological Characteristics - Output Power (per diode) | Same as previous model (≤ 5mW) | Same as previous model (≤ 5mW) |
| Technological Characteristics - Number of Diodes | 272 | 82 |
| Treatment Regimen | Maximum 30 minutes, every other day (indefinite) | Maximum 30 minutes, every other day (indefinite) |
| Electrical Safety | (Not explicitly stated for 272 Pro) | Charger conforms to IEC 61959. |
Study Proving Acceptance Criteria:
The document describes the Capillus 82 as a modification of the previously cleared Capillus 272 Pro (K143199). The "study" for the Capillus 82 is primarily focused on design control activities, verification, and validation to demonstrate that the reduction in the number of lasers does not introduce new safety concerns and that the device still performs its intended function, albeit potentially with slower efficacy.
The key points regarding how the device meets acceptance criteria are:
- Substantial Equivalence Argument: The core of the submission is the claim that Capillus 82 is substantially equivalent to predicate devices (Capillus 272 Pro, Theradome Laser Helmet, MEP-90) and reference devices (Hairmax Lasercomb). This implies that if the predicate devices met their acceptance criteria, and the Capillus 82 is sufficiently similar, it also meets criteria.
- Design Control Activities (21 CFR 820.30): The manufacturer followed design control procedures. This involved:
- Risk Assessment: Identified and assessed risks of reducing diodes; found no significant changes or risks for the Capillus 82 compared to the Capillus 272 Pro.
- Verification: Activities were performed to assess the impact of the change (reduction of laser diodes). Laser diode output remained the same, but dosage was reduced.
- Validation: Feedback from specialists and consumers indicated acceptance of a lower-cost alternative with potentially slower efficacy, understanding that treatment is indefinite.
- Conformity to Standards:
- IEC-60825-2007-03: The device conforms to this standard for laser safety, establishing it as a Class 3R laser with an AEL of 5mW maximum.
- IEC 61959: The charger conforms to this standard.
The document explicitly states: "Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criterion were met by the device." (Page 6)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a new clinical "test set" for the Capillus 82. The verification and validation activities are primarily engineering and risk-based, comparing the modified device to the established performance of the predicate. Data provenance for the original predicate device's studies is not detailed in this 510(k) summary.
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)
Not applicable. This is not a diagnostic device or an AI algorithm requiring expert ground truth for a test set in the traditional sense. "Ground truth" for efficacy of this type of device is typically established through clinical trials (which would have been done for the predicate devices). "Feedback from hair restoration specialists and consumers" was used for design validation (page 5), but details on the number or qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is a physical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the efficacy claim (promoting hair growth) of this technology (Low-Level Laser Therapy) would have been established through clinical trials for the predicate devices and other similar devices, likely using outcomes data such as hair count measurements and photographic assessments. For the Capillus 82 itself, the ground truth is essentially the established performance and safety profile of the predicate device, against which the modifications are evaluated for substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
§ 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.