(84 days)
The Capillus272 Pro is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV
The Capillus272Pro consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner. The use of this specific number of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Nickel Metal Hydride battery cells assembled into a proprietary battery pack. Both the battery cells, pack and charger are fully compliant to recognized, international standards.
The Capillus 272 Pro is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.
Here's an analysis of the provided information regarding the Capillus 272 Pro, organized according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., a certain percentage increase in hair count for FDA clearance). Instead, the performance is reported as an "effectiveness" measure relative to a placebo.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Promotion of hair growth | 100% effectiveness (all subjects showed positive result for increase in terminal hair counts) |
| Safety | No anticipated adverse events and none reported that were study-related |
| Functionality | Device functioned as anticipated |
| Efficacy (over placebo) | 51% positive variance over the placebo group from baseline |
| Decrease in terminal hair counts | Zero decrease in terminal hair counts in the active group |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a single number, but there were subjects in both the Capillus 272 Pro (active) group and the placebo group.
- Data Provenance:
- Country of Origin: United States (multi-center, two sites).
- Retrospective or Prospective: Prospective.
3. Number of Experts for Ground Truth and Qualifications
This information is not provided in the document. The study describes a "placebo-controlled, prospective trial" but does not detail how the ground truth for hair growth was assessed (e.g., by experts, automated systems, etc.).
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. The study was a comparison of the device to a placebo, not an assessment of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
The device described is a physical light therapy device, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.
7. Type of Ground Truth Used
The document implies that the ground truth for "hair growth" was established by measurements of terminal hair counts and observations of "positive results" for an increase in these counts. However, the exact methods for these measurements (e.g., photographic assessment, dermatoscopic analysis, direct counting) and who performed them are not detailed.
8. Sample Size for the Training Set
This information is not provided in the document. The study described is a clinical trial to evaluate the device's efficacy, not a study to train a new algorithm. "Training set" is typically relevant for AI/machine learning models.
9. How Ground Truth for Training Set Was Established
This information is not provided and is not applicable as there is no mention of a training set for an algorithm in this context.
§ 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.