(239 days)
The Laser-Stim, Model LS2001, is intended to emit energy in the 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 promoting relaxation of muscles.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Laser - Stim LS2001" infrared lamp. This type of device does not typically undergo studies to demonstrate performance against specific, quantifiable acceptance criteria in the same way a diagnostic or AI-driven device would.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate. Clinical studies, especially those with acceptance criteria and ground truth, are generally not required for these types of devices unless there are significant differences in technological characteristics or intended use that raise new questions of safety and effectiveness.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not typically found in a 510(k) clearance document for an infrared lamp like the "Laser - Stim LS2001."
The document states:
- Regulation Name: Infrared Lamp
- Regulatory Class: Class II
- Product Code: ILY
- Indications For Use: The Laser-Stim, Model LS2001, is intended to emit energy in the 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 promoting relaxation of muscles.
This device is cleared based on its equivalence to other infrared lamps already on the market, implying that the general safety and effectiveness of infrared lamps for these indications are already well-established. The submission likely focused on engineering specifications, electrical safety, biocompatibility (if applicable), and comparison to a predicate device rather than a prospective clinical study with performance-based acceptance criteria against a ground truth.
In summary, based on the provided document, I cannot fulfill the request for information regarding acceptance criteria and study details because the nature of this device and its 510(k) clearance process do not typically involve such studies.
§ 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.