(10 days)
The GE 0.2T 6-inch GP Coil is a 2-turn solenoid receive only coil designed for MR imaging. The coil has a soft pad, which helps to place the position to be examined in the center of the coil and provides comfort as well. The coil is a general-purpose coil that can be used to image the Cervical Spine, the neck, shoulder, and other extremity anatomy. The coil connects to the Signa MRI system by way of the interface connector.
The GE 0.2T 6-inch GP Coil is designed for MR imaging of general purpose of the human anatomy. The coil is a 2-turn solenoid coil in series that provides high signal to noise ratio. The coil has blocking networks to decouple the coil during body coil transmit condition.
The provided text describes the 510(k) summary for the GE 0.2T 6-inch GP Coil, which is a magnetic resonance coil. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a standalone algorithm for medical image analysis, human reader performance, or ground truth establishment relevant to AI/ML device descriptions.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Signa Profile 9 inch coil) for regulatory purposes. The "Summary of Studies" section only states:
"The 0.2T 6-inch GP coil is evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and labeling requirement of IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. Testing was performed to demonstrate that the design met predetermined acceptance criteria."
This statement confirms that testing was done to meet design acceptance criteria based on NEMA and IEC standards for electrical and safety performance of the MRI coil itself, not diagnostic performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, AUC).
Therefore, based solely on the provided text, I cannot complete the requested tables and answer the questions for an AI/ML medical device submission. The device described is a physical medical component (an MRI coil), not a software algorithm that generates diagnostic outputs or assists human readers with interpretations.
If this were an AI/ML device, the information I would be looking for, but which is absent, would be:
- Table of Acceptance Criteria and Reported Device Performance: This would typically include metrics like sensitivity, specificity, AUC, accuracy, F1-score, and their respective thresholds.
- Sample size for the test set and data provenance: Number of cases, breakdown by imaging modality, disease prevalence, and demographic details.
- Number of experts used to establish ground truth & qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study: Effect size of human readers improving with AI vs. without AI assistance.
- Standalone performance study: Metrics like sensitivity, specificity, AUC, etc., for the algorithm alone.
- Type of ground truth used: e.g., histopathology, clinical follow-up, consensus of multiple experts.
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion based on the provided text:
The document describes the regulatory submission for a physical MR coil, not a diagnostic AI/ML software device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance metrics (such as sensitivity, specificity, MRMC studies, or ground truth generation for diagnostic outputs) is not present in the provided text. The "acceptance criteria" mentioned pertain to the physical and electrical safety and performance of the coil itself as per NEMA and IEC standards.
§ 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.