(20 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician.
QWH-250 PAN Wrist Wrist Array Coil
This is a 510(k) clearance letter from the FDA for a device called the "QWH-250 PAN Wrist Wrist Array Coil," which is a magnetic resonance diagnostic device used to produce diagnostic images of the wrist and hand.
The provided text is an FDA clearance letter and does not contain information about acceptance criteria, study design, or performance metrics in the way you've outlined for AI/ML device evaluations.
FDA 510(k) clearances for devices like MRI coils typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria and ground truth validation that are common for AI/ML algorithms.
Therefore, for your requested information, I must state:
- A table of acceptance criteria and the reported device performance: Not available in this document. The letter indicates the device is substantially equivalent to a predicate.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document.
- 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, as this is not an AI/ML device needing ground truth establishment in this context.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
What the document does provide is:
- Device Name: QWH-250 PAN Wrist Wrist Array Coil
- Regulation Number: 21 CFR 892.1000
- Regulation Name: Magnetic resonance diagnostic device
- Regulatory Class: II
- Product Code: 90 MOS
- Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician."
This letter confirms that the FDA found the MRI coil substantially equivalent to existing predicate devices, meaning it is considered as safe and effective as those already on the market without requiring new clinical efficacy trials in the way an AI/ML product might.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.