(130 days)
The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the prowth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.
The Hair Growth System Model: KN-8000A is a transportable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. It produces a red light, diode lasers operating at a 650-nanometer wavelength (maximum output power of each is 5 mW). The device mainly includes a host machine, light source and lifting bracket. The light source applicator was equipped with the access sensor device, it can power off the light source when the patient's scalp deviates from the work area.
The provided text is a 510(k) summary for the "Hair Growth System (Model: KN-8000A)" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details for an AI model.
The "Test Summary" section in the document only mentions:
- Electrical safety test (IEC 60601-1 and IEC 60825-1 standards)
- Electromagnetic compatibility test (IEC 60601-1-2 standard)
- Software verification and validation test (according to FDA guidance for software in medical devices)
These tests are related to the safety and fundamental performance of the device's hardware and software, but not to the clinical effectiveness or performance of an AI component in achieving a specific outcome (like hair growth based on algorithmic assessment). The device itself is described as a "low-level laser device" not explicitly an AI-driven system.
In summary, none of the requested information regarding AI/algorithm acceptance criteria and study details is present in the provided text. The document's purpose is to establish substantial equivalence for a physical device, not to describe the validation of 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.