(200 days)
The Diowave Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
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This document is an FDA 510(k) clearance letter for a medical device called the "Diowave Laser System." This type of document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a clinical trial report or a more extensive technical submission for an AI/ML powered device.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, ground truth establishment) is not present in this document.
Here's what can be extracted based on the provided text:
- Device Name: Diowave Laser System
- Regulation Number: 21 CFR 890.5500
- Regulation Name: Infrared lamp
- Regulatory Class: Class II
- Product Code: ILY
- Indications for Use: The Diowave Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Explanation for missing information:
The FDA 510(k) process for a device regulated as an "Infrared lamp" (product code ILY) largely relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (e.g., wavelength, power output, safety features) and intended use. It does not generally require the submission of detailed clinical performance studies, especially those involving AI/ML algorithms, human reader studies, or complex ground truth establishment, which are more common for novel diagnostic or AI-powered devices. The clearance indicates that the device's performance is considered acceptable because it is similar to existing, approved devices for the stated indications.
To answer your specific questions in the format requested, with the understanding that most information is not available from this document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document, as it relies on substantial equivalence to a predicate device. | Not specified in this document, as it relies on substantial equivalence to a predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable/Not mentioned. The 510(k) clearance for this type of device does not typically require a test set of this nature.
- Data provenance: Not applicable/Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/Not mentioned.
- Qualifications of experts: Not applicable/Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not mentioned.
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
- MRMC study: Not applicable/Not mentioned. This device is not an AI-powered diagnostic tool, so such a study would not be relevant.
- Effect size: Not applicable/Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study: Not applicable/Not mentioned. This device is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable/Not mentioned. The 510(k) for this device relies on demonstrating equivalence to predicate devices, not on a ground truth for diagnostic accuracy.
8. The sample size for the training set
- Sample size for training set: Not applicable/Not mentioned. This device is not an AI/ML powered device requiring a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/Not mentioned.
§ 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.