(64 days)
HeatLux Pro I is over the counter hand held device intended to emit energy in the visible and near IR spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscular and joint pan and stiffness, minor arthritis pam or muscle spasm, the temporary increase in local and blood carculation, and temporary relaxation of muscles.
The HeatLux Pro I device is a hand held device, using low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm, combined with four metal heating plates (temperature stabilized to 41%). The HeatLux Pro I device consists of an applicator and an AC/DC power adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin.
I am sorry, but the provided text is a 510(k) summary for a medical device and does not contain the detailed information necessary to answer your request in the specified format. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance, clinical study designs, or expert-based ground truth establishment for a machine learning algorithm.
Specifically, the document states:
- "Clinical Performance Data: Not Applicable"
- "Pre-Clinical (Animal Study) Performance Data: Not Applicable"
- "Non-Clinical (Bench) Performance Data: A set of bench tests were performed to evaluate the thermal profile and temperature stability of the HeatLux Pro I device and to compare them to the thermal profile and temperature stability of the HeatLux 1 device. The results of the bench tests demonstrated that the HeatLux Pro I device has the same thermal profile and temperature stability properties as those reported for the predicate device."
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven task.
- Sample sizes, data provenance, or details on test sets.
- Information on experts, ground truth establishment, or adjudication methods.
- Details on MRMC studies or human reader improvement with AI.
- Standalone algorithm performance.
- Ground truth types for algorithm training or testing.
- Training set sample size or how its ground truth was established.
This document describes a device that provides topical heating and relies on demonstrating similar thermal characteristics to a previously cleared device, rather than an AI/ML-driven diagnostic or treatment selection device that would require the information you've requested.
§ 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.