(53 days)
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.
| Acceptance Criteria (for AI/ML devices) | Reported Device Performance (N/A for this device) |
|---|---|
| N/A | N/A |
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.
§ 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.