(168 days)
This device is intended to for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation
OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit
The provided FDA letter for K060191 describes the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. However, it is a 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device. This type of regulatory submission typically does not contain detailed information about specific acceptance criteria, performance studies with sample sizes, or ground truth establishment in the way that would be found in a De Novo or PMA submission for novel devices or higher-risk devices.
Therefore, many of the requested details about acceptance criteria and study particulars are not present in the provided text. The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and general controls.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The 510(k) clearance is based on substantial equivalence to a predicate device, not on specific acceptance criteria and performance metrics for the new device as would be detailed in a PMA or De Novo.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document does not describe any specific clinical or performance studies with test sets, sample sizes, or data provenance.
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)
- Not applicable/Not available in the provided text. A 510(k) clearance, especially for an infrared lamp, typically does not involve establishing ground truth by a panel of experts in the way an AI/CAD device would. The safety and effectiveness are inferred from the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available in the provided text. No adjudication method for a test set is mentioned as no such study is described.
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/Not available in the provided text. The device is an infrared lamp, not an AI/CAD system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available in the provided text. The device is not an algorithm; it's a physical medical device (an infrared lamp).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available in the provided text. Ground truth in the context of diagnostic or AI devices is not relevant to an infrared lamp's 510(k) submission.
8. The sample size for the training set
- Not applicable/Not available in the provided text. This device does not involve a training set as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not applicable/Not available in the provided text. As there is no training set, there is no ground truth establishment for one.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and similar safety and effectiveness profile as a previously cleared device. It does not typically require or describe the detailed performance studies, specific acceptance criteria, sample sizes, or ground truth establishment that would be associated with novel or higher-risk devices, especially those incorporating AI or complex diagnostic algorithms.
§ 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.