(91 days)
The Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
The Phoenix Thera-Lase System is a stand-alone, solid-state class IV laser system specifically designed to provide efficient, high-power laser output with air-cooling and an output wavelength of 1060 nm. The laser output provides a 0.75-1.88 inch diameter spot to provide non-contact laser output to patients. The laser system has three different operation modes: Continuous wave, Single, and Repeat mode.
The Laser system consists of three main components: Laser Diode Module, Remote Controller, and Fiber Optic delivery cable with hand piece. The Laser Diode Module contains the power supply system and the laser diode. The Remote Controller controls the laser module through a touch screen activated control panel. The Fiber Optic delivery cable is connected to the Laser Diode Module to provide a route for administration of the laser output.
The provided text is a 510(k) summary for the Phoenix Thera-Lase System. It outlines the device's intended use, technological characteristics, and non-clinical data based on safety testing and comparison to predicate devices, but it does not contain information about studies proving the device meets acceptance criteria related to a specific clinical performance metric (e.g., diagnostic accuracy, efficacy in pain relief as measured by a clinical trial).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as the document focuses on demonstrating substantial equivalence based on safety, technological characteristics, and comparison to legally marketed predicate devices, rather than detailed clinical performance studies with specific statistical endpoints.
Specifically, the document states:
- "Testing was performed which demonstrates that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s)."
- "Tests included verification/validation testing to internal functional specifications (including software), and non-clinical skin temperature evaluations."
This indicates that the "studies" performed were primarily non-clinical, focusing on engineering verification/validation, electrical safety, electromagnetic compatibility, and demonstrating that the device's skin temperature elevation is within acceptable ranges for topical heating. It does not describe a clinical study designed to demonstrate a specific level of pain relief or other therapeutic outcome against predefined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about clinical performance studies, ground truth, expert adjudication, or sample sizes for clinical effectiveness trials, because such information is not present in the provided text.
§ 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.