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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.

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The Quantum WARP 10 Light Delivery System 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; and to temporarily increase local blood circulation where applied.

The Quantum WARP 10 Light Delivery System is used for applying therapy for the mitigation of chronic pain. These light delivery systems are manufactured by Quantum Devices, Inc. These devices are solid state and hand held for placement on the area where treatment is to occur.

The provided document is a 510(k) premarket notification for the Quantum WARP 10 Light Delivery System. It is a traditional medical device submission, not a submission for an AI/ML-driven device. As such, it does not include the typical information requested for AI/ML device studies.

Therefore, many of the requested fields cannot be filled. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than presenting a detailed study with acceptance criteria and performance metrics in the way an AI/ML product would.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device, as this is a traditional medical device premarket notification. The "acceptance criteria" for a 510(k) are typically that the device is "substantially equivalent" to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance

No test set for AI/ML performance is mentioned. The document describes a "Testing Summary" focused on temperature at the skin surface, indicating safety testing rather than a clinical performance study.

• Sample Size (Test Set): Not specified (likely not applicable for a "test set" in the AI/ML sense).
• Data Provenance: Not specified. Testing was carried out "to ensure that the temperature at the skin surface where the device is applied is acceptable per 10 Chance ma Part 42.3 (11.2601-1)". This refers to safety testing, not performance data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment for a diagnostic or prognostic AI/ML output is mentioned.

4. Adjudication method for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a light delivery system for pain relief, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

For the safety testing mentioned (skin surface temperature), the "ground truth" would implicitly be the established safety limits for temperature. For substantial equivalence, the "ground truth" is the performance and safety characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established

Not applicable.

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