Search Results

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

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.

Ask a specific question about this device