(90 days)
The SuperGrow 272 laser hat and the Ultimate 272 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 SuperGrow 272 and the Ultimate 272 are non-invasive, low level laser therapy (LLLT) devices each containing 272 red, visible light, diode lasers. The devices are designed to deliver non-thermal energy to the hair follicles via photostimulation of the scalp. The SuperGrow 272 consists of 272 red, visible light, diode lasers operating at a 650 nanometer wavelength (maximum output power of each is 5 mW). The diodes are configured within a cap, enclosed between the outer shell and inner liner, both made of polyethylene terephthalate (PET). The Ultimate 272 is exactly the same as the SuperGrow 272 in every way except it is mounted on a stand. The same electrical design (power supply and the on/off switch) has been applied to the Ultimate 272.
A clinical usability study was performed to assess the ability of average "retail customers" to self-select and appropriately use the device. The study sought to demonstrate that the device is safe for over-the-counter distribution.
Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Threshold | Reported Performance (Success Rate) |
|---|---|---|
| Ability to self-select (based on indications and contraindications) | ≥ 80% | 80% |
| Comprehension of instructions | ≥ 80% | 82.5% |
| Proper use of the device | ≥ 80% | 80% |
Study Details
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Sample Size and Data Provenance:
- Test Set Sample Size: 40 subjects.
- Data Provenance: Not explicitly stated, but the study assesses "average retail customers," implying data would be collected from individuals representative of prospective consumers. The study was conducted presumably in the U.S. where the device is intended to be marketed. Likely prospective based on the nature of a usability study.
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Number and Qualifications of Experts: Not applicable, as this was a usability study with consumers, not expert reviewers of medical images or diagnoses. An "observer" evaluated the subjects' ability to use the device.
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Adjudication Method: Not applicable. The study involved direct observation and assessment of subjects' interactions with the device and packaging.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This was a usability study, not an MRMC study comparing human readers with and without AI assistance.
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Standalone Performance: This study focused on user interaction and comprehension in an over-the-counter context. It assesses the device's usability in a standalone setting (without professional medical guidance) but does not evaluate the purely algorithmic performance of an AI. The device itself (SuperGrow 272 / Ultimate 272) is a non-AI low-level laser therapy device.
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Type of Ground Truth: The ground truth was established by pre-defined correct answers for self-selection and instruction comprehension, and pre-defined correct procedures for proper device use, as assessed by an observer.
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Training Set Sample Size: Not applicable. This was a usability study, not a machine learning model training study.
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Ground Truth for Training Set: 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.