(117 days)
WARP-75 is a hand held device used for the treatment of chronic pain by emitting energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; to temporarily increase local blood circulation where applied.
The Quantum WARP Light Delivery System (WARP-75) is used for applying therapy for the mitigation of chronic pain. Quantum Devices, Inc manufactures this light delivery system. These devices are solid state and hand held for . placement directly over the skin where the treatment is to occur.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum WARP 75 Light Delivery System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature at the skin surface where the device is applied is acceptable per IEC 60601-1 Part 42.3 (UL2601-1). | "Testing for the Quantum WARP 75 Light Delivery Systems has been carried out to ensure that the temperature at the skin surface where the device is applied is acceptable per IEC 60601-1 Part 42.3 (UL2601-1)." (This statement indicates compliance, but no specific numerical performance data is provided in the summary.) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. The document only mentions "Testing for the Quantum WARP 75 Light Delivery Systems has been carried out."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The testing for this device primarily involves physical compliance with safety standards (temperature at skin surface), not diagnostic accuracy requiring expert interpretation.
4. Adjudication Method
This information is not applicable as there is no diagnostic or interpretive element in the described testing that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The device is for therapeutic use (chronic pain relief), not for diagnostic interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
It appears that a standalone test was performed in the sense that the device's physical parameters (skin surface temperature) were evaluated independently against a standard. However, the term "standalone" typically refers to the performance of a diagnostic algorithm without human intervention in a medical imaging context. Given this device's nature, this question isn't directly applicable in the typical sense. The testing described focuses on the device's inherent safety performance, not an algorithm's diagnostic output.
7. The Type of Ground Truth Used
The ground truth used for the testing was adherence to a safety standard, specifically "IEC 60601-1 Part 42.3 (UL2601-1)" for acceptable skin surface temperature. This is a technical/engineering ground truth, not a clinical ground truth like pathology or expert consensus.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical light delivery system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned or implied for this 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.