(68 days)
Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.
Model 414GE-09 Linear Shoulder Coil. Compatible with GE Signa Profile 0.2 T MRI systems.
The provided text describes a 510(k) premarket notification for a new MRI coil, the Model 414GE-09 Linear Shoulder Coil. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for a new type of AI/algorithmic device.
Therefore, many of the requested elements for an AI/algorithmic device study are not applicable or cannot be extracted from this document, as this is a physical medical device (an MRI coil).
However, I can extract information related to the device's technical specifications and how its "performance" (in terms of safety and imaging parameters) is compared to the predicate device to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
For this device, "acceptance criteria" are implicitly defined by the safety and imaging performance parameters of the predicate device. The new device is considered acceptable if it performs "no change" or equivalently to the predicate device in these parameters. There are no numerical performance metrics or thresholds explicitly stated as acceptance criteria in the document for the new device itself, but rather a qualitative comparison to the predicate.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (vs. Predicate) |
|---|---|
| Maximum Static Magnetic Field: No change from predicate | No change |
| Rate of Magnetic Field Strength Change: No change from predicate | No change |
| RF Power Deposition: No change from predicate | No change |
| Acoustic Noise Levels: No change from predicate | No change |
| Specification Volume: No change from predicate | No change |
| Signal-to-Noise Ratio: No change from predicate | No change |
| Image Uniformity: No change from predicate | No change |
| Geometric Distortion: No change from predicate | No change |
| Slice Thickness and Gap: No change from predicate | No change |
| High Contrast Spatial Resolution: No change from predicate | No change |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on demonstrating that the new coil, when used with the GE Signa Profile 0.2T MRI system, operates equivalently in terms of safety and imaging parameters to the predicate device. It doesn't describe a clinical study with a specific test set of patients or images.
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)
This information is not applicable and not provided. This device is an MRI coil, not an AI or algorithmic diagnostic tool requiring expert ground truth for interpretation. The "ground truth" here would relate to the physical and electrical performance of the coil itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
An MRMC study is not applicable and not mentioned. This is a physical device (MRI coil), not an AI algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study as described for AI algorithms is not applicable. This is a physical MRI coil. Its "performance" refers to its ability to generate MRI signals and images with specific physical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context would be based on physical measurements and engineering tests of the coil's performance against established specifications and comparison to the predicate device. It would involve objective measurements of magnetic field properties, RF power, signal-to-noise ratio, image uniformity, etc., using phantoms or controlled environments, not clinical ground truth like pathology for diagnostic algorithms. The document does not detail the specific method for establishing this "ground truth" beyond stating "no change" from the predicate.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
§ 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.