(224 days)
The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV
Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.
The provided text is a 510(k) Summary for the "Irradiation Aesthetic Device (Model: HairPro)". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo clinical efficacy or safety through a separate performance study with acceptance criteria.
Therefore, the document does not report on a study that proves the device meets specific performance acceptance criteria in the way you've described (e.g., in terms of clinical accuracy, sensitivity, specificity, etc., for a diagnostic AI device). This is a marketing clearance for a device like an "Infrared Lamp" which generally relies on established safety and performance standards for similar devices already on the market.
Here's why the requested information cannot be fully provided from this document:
- Acceptance Criteria & Device Performance Table: The document provides "Comparison to Predicate Device" (Section 7) which lists various technical specifications and their values for the subject device and predicate devices. This is a comparison for substantial equivalence, not a list of acceptance criteria for a new performance study. The "Verdict" column indicates "SE" (Substantially Equivalent) rather than a pass/fail against a quantitative criterion.
- Sample Size and Data Provenance: This document describes bench testing against electrical safety, electromagnetic compatibility, laser safety, and biocompatibility standards (Section 6). It does not mention any clinical study involving patients or a "test set" of patient data for performance evaluation. The "Attachment 9" and "Attachment 10" are references to reports for these technical tests, not clinical data.
- Experts for Ground Truth/Adjudication Method: Since no clinical performance study involving an AI component or diagnostic capability is mentioned, there's no discussion of ground truth establishment or expert adjudication.
- MRMC Comparative Effectiveness Study: No such study is mentioned. The device is a "Irradiation Aesthetic Device" (likely a low-level laser therapy device for hair growth), not a diagnostic AI.
- Stand-alone Performance: Not applicable as it's not a diagnostic AI device.
- Type of Ground Truth: Not applicable, as no clinical performance study for an AI or diagnostic function is described. The ground truth refers to established standards for the material and electrical properties of the device.
- Training Set Sample Size and Ground Truth Establishment (for training set): Not applicable, as this is not an AI/machine learning device that requires a training set of data.
In summary, based solely on the provided 510(k) summary, the device is cleared based on its substantial equivalence to predicate devices, supported by bench testing conforming to relevant safety and performance standards, rather than a clinical study with new performance acceptance criteria.
The "acceptance criteria" for this clearance are implicitly met if the device demonstrates (through engineering specifications and bench testing) that it is as safe and effective as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
If this were an AI/ML medical device, the 510(k) summary would typically include a "Clinical Performance" section detailing studies with specific endpoints and criteria. This document does not contain such a section.
§ 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.