(91 days)
The device is indicated for emitting 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 arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
K-1200 is an infrared therapy table device, easy to transport, usable also without electrical net, thanks to a battery pack. It is composed of a touch screen for managing all the device functions, an emitter, an handpiece for the delivery of light, software and an on/off button to activate and deactivate the infrared emission.
This submission is for a 510(k) premarket notification for the K-1200 device, an infrared therapy device. The provided text is a summary of the safety and effectiveness, predicate devices, performance standards, description, intended use, and substantial equivalence rationale. It does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific acceptance criteria in the manner a clinical trial or performance study would.
The document asserts substantial equivalence to predicate devices (K-LASER, K050070, and LCT-1000, K070400) based on shared basic characteristics and intended use. The safety and effectiveness are also stated generally to be due to similarity to existing technologies, mature quality management systems, and certifications (CERMET, 93/42 EEC Directive).
Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set size, and ground truth establishment for training set) because this type of information is not present in the provided 510(k) summary. These details would typically be found in performance data sections of a more comprehensive submission, which are absent here.
The document does state that the device "conforms to the applicable requirements of 21 CFR section 1010 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products)." However, these are general regulatory compliance statements rather than specific acceptance criteria for a device's clinical performance.
§ 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.