(28 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the elbow that can be interpreted by a trained physician.
EXS-63 Small Extremity Array Coil
This is a 510(k) clearance letter from the FDA for a Magnetic Resonance (MR) coil, specifically the EXS-63 Small Extremity Array Coil. This type of device is an accessory to a larger imaging system (an MRI scanner) and is primarily judged on its safety and effectiveness as an imaging component, rather than through complex AI performance metrics.
Therefore, the requested information about acceptance criteria, study details for AI performance, sample sizes for training/test sets, ground truth establishment, and expert involvement is not applicable to this document or the device it describes.
This document confirms that the device is substantially equivalent to legally marketed predicate devices, which means its performance is expected to be similar to existing, approved devices that have already demonstrated safety and effectiveness for diagnostic imaging of the elbow. The "acceptance criteria" here implicitly refer to meeting the established standards for such MR coils at the time of clearance (2002).
Key takeaways from the document regarding "acceptance" and "proof":
- Acceptance Criteria (Implicit):
- Safety: The device must be safe for use in conjunction with an MRI scanner.
- Effectiveness: The device must be capable of producing diagnostic images of the elbow when used with an MRI scanner that can be interpreted by a trained physician.
- Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety and effectiveness.
- Study Proving Acceptance (Implicit):
- The "study" is the 510(k) premarket notification submitted by MRI Devices Corporation.
- This notification would have included information demonstrating how the EXS-63 coil is substantially equivalent to a predicate device. This typically involves:
- Comparison of Technical Specifications: Demonstrating similar materials, design, operating principles, and performance characteristics (e.g., signal-to-noise ratio, homogeneity, imaging capabilities) to the predicate device.
- Performance Testing: Bench testing or phantom studies to show that the coil meets basic performance expectations for an MRI coil.
- Risk Assessment: Demonstrating that any risks associated with the device are comparable to or less than those of the predicate device.
- Clinical Data (if necessary): While often not required for substantial equivalence for accessories like coils if technical equivalence is strong, some observational or limited clinical data might be presented to support image quality if differences from the predicate are significant. However, based on the document, it's highly likely this was a technical substantial equivalence determination.
Summary of requested information in context of this document:
- Table of acceptance criteria and reported device performance: Not explicitly stated as specific metrics for this device type in this document. The "performance" is implicitly its ability to produce diagnostic images of the elbow, demonstrated by substantial equivalence to a predicate.
- Sample size for the test set and data provenance: Not applicable. No "test set" in the context of AI performance is mentioned.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for AI algorithms is not relevant here.
- Adjudication method for the test set: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is not an AI device.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This is not an AI device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In essence, this document is a regulatory approval for a medical device accessory based on its physical and functional characteristics, not on software algorithm performance or AI metrics.
§ 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.