(192 days)
The TDP CQG-111A/B. CQG-222A/B. CQG-270A/B and CQG-222D Heat Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The TDP CQG-111A/B, CQG-222A/B, CQG-270A/B and CQG-222D lamps can be used to emit topical heating to the body of human. The TDP Lamps are specially designed to use a curing plate that is made of a rare earth and minerals. Emission spectrum ranges from 1 to 25 microns. The life of emission curing plate is 1,000 to 1,500 hours. When the curing plate is used up to 1,000 hours, the treatment effect of the curing plate will gradually depressed. After the curing plate is used for 1,500 hours, it should be replaced with a new one. The device manufactured for the United States of America uses 110 volts power and 250 (or 275) watts. All models have 1 safety fuse, 4-swivel heater and a safety grilling cover. All models include a 60-minutes timer. Only difference between Model "A" (or "D") and Model "B" is the control system. Model "A" (or "D") TDP is controlled with a mechanical system, but Model "B" TDP is controlled with an electronic system.
This document, a 510(k) Pre-Market Notification, describes an infrared heat lamp and its substantial equivalence to predicate devices. It primarily focuses on regulatory compliance and does not provide information about clinical studies, acceptance criteria, or performance metrics in the way a modern AI/device study would. Therefore, I cannot extract the requested information in the format requested.
Here's why and what information can be inferred:
- No acceptance criteria for device performance: This submission is for a heat lamp, a well-established device type. The "acceptance criteria" here refer to regulatory acceptance, specifically demonstrating "substantial equivalence" to existing legally marketed devices, rather than performance against pre-defined clinical metrics.
- No study to prove device meets acceptance criteria (in the modern sense): The "study" for this type of device is the demonstration of substantial equivalence through comparison of technological characteristics and intended use with predicate devices. There wouldn't be a clinical trial with performance metrics like accuracy, sensitivity, or specificity.
- No AI component: This is a physical medical device (an infrared heat lamp), not an AI-powered diagnostic or therapeutic tool. Therefore, questions about human readers, AI assistance, training sets, ground truth, or adjudication methods are not applicable.
What can be extracted or inferred from the document regarding its "acceptance":
- Acceptance Criteria (Regulatory): The primary acceptance criterion was demonstrating "substantial equivalence" to legally marketed predicate devices. This means the device has the same intended use and similar technological characteristics to devices already cleared by the FDA.
- Device Performance (Regulatory Equivalence): The report states, "The TDP Lamps manufactured by Chongqing Silicate Research Institute meets the general specifications, criteria, and effectiveness for heat lamps. The TDP Lamps also have the same technological characteristics as their predicate device such as TDP CQ-27 lamp." This is the "performance" claim in this context – it performs equivalently to predicate devices.
- Ground Truth (for regulatory acceptance): The "ground truth" for regulatory acceptance is the established safety and effectiveness profile of the predicate devices.
- Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone/Training Set: These concepts are not applicable to this type of 510(k) submission for a non-AI physical device. The review process involved FDA's evaluation of the submitted documentation, not clinical trials with human readers or AI algorithms.
In summary, as per your request format, this document does not contain the information needed because it's a regulatory submission for a physical medical device, not a performance study for an AI-enabled 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.