(89 days)
The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
The LUMIX ULTRA IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.
The LUMIX ULTRA IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser quide light with 3 mW of power. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.
The control consoles are made of standard medical PVC material and are designed to be placed on a desktop or table in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.
The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.
The provided text describes a 510(k) premarket notification for the LUMIX ULTRA IR Lamp Systems, which are infrared therapeutic heat lamps. This document reviews the device's substantial equivalence to predicate devices and its compliance with safety standards, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data or algorithm-based performance metrics.
The document primarily focuses on:
- Indications for Use: Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; temporary increase in local blood circulation; and/or temporary relaxation of muscle.
- Device Description: Non-invasive devices emitting visible and invisible laser light beams (650-1064 nm) for therapeutic elevation of tissue temperature.
- Predicate Devices: Other therapeutic heat lamps (LUMIX 3 Series, NEXUS Series, CYNOSURE 1064nm Diode Laser, ELTECH s.r.l. K-Laser Cube).
- Testing: Functional performance testing and electrical safety testing to comply with international standards (e.g., IEC 60601-1, IEC 60825-1, ISO 14971).
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy or AI performance, as this type of information is not present in the provided text. The document confirms that the device is "substantially equivalent" to existing predicate devices based on intended use, functional, and performance characteristics, and compliance with general safety standards.
In summary, the document does not provide the information needed to fill out the table and answer the specific questions about acceptance criteria and a study proving device performance in the manner you've outlined for an AI/diagnostic device.
§ 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.