(16 days)
i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.
ii. Magnetic resonance angiography.
The 1.5T Pediatric Head and Spine Array, Catalog #808GE1500, interfaces with the G.E. 1.5 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inputs and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.
This document describes a 510(k) submission for a new medical device, the "1.5T Pediatric Head and Spine Array," which is an MRI accessory coil. The submission aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device (1.5T Pediatric Array #801GE1500, K051640).
The key takeaway is that this submission does not contain a study proving the device meets specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, image quality scores). Instead, it demonstrates substantial equivalence by highlighting that the new device has the same technological characteristics as the unmodified device with only minor changes to size and physical orientation of coil elements, and that the materials, use, and safety features are equivalent. The intended use also remains virtually identical.
Therefore, for the information requested in your prompt, I can only provide what is available in the text.
Here's a breakdown of why many of your specific questions cannot be answered from the provided text:
- Acceptance Criteria & Device Performance: The document does not define specific performance-based acceptance criteria (e.g., image signal-to-noise ratio, image resolution, diagnostic accuracy) that would be typically found in a clinical study for a diagnostic AI device. The "performance" described is in terms of technological characteristics and intended use being equivalent to a predicate device, not in terms of achieving specific quantitative diagnostic metrics.
- Studies: The document is a 510(k) summary and the FDA's response letter. It does not include a detailed study report with methods, results, or statistical analysis of device performance. The "study" here is essentially the comparison of the new device's technical specifications and intended use against a predicate device. This is a common approach for Class II devices that are substantially equivalent, where extensive new clinical performance studies are not always required if equivalence can be demonstrated through other means (e.g., engineering analysis, bench testing, comparison to predicate).
Based on the provided text, here is the information that can be extracted, acknowledging the limitations mentioned above:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Technological Characteristics Equivalence: The new device should have substantially similar technological characteristics to the predicate device. | The modified device has the "same technological characteristics as the unmodified device with only minor changes to the size and physical orientation of the individual elements of the multi-element or multi-channel MRI antenna (coil)." (510(k) Summary, point 6) |
| Material Equivalence: Materials used should be equivalent. | "The materials... are equivalent." (510(k) Summary, point 6) |
| Use Equivalence: Use of the device should be equivalent. | "The... use... are equivalent." (510(k) Summary, point 6) |
| Safety Features Equivalence: Safety features should be equivalent. | "The... safety features are equivalent." (510(k) Summary, point 6) |
| Intended Use Equivalence: The intended use should be equivalent to the predicate device. | The intended use "is not substantively different than that of the unmodified device." (510(k) Summary, point 5). The "Intended Use Statements remain virtually identical to those of the unmodified device." (Appendix A) |
| Stated Intended Uses: | |
| i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system. | |
| ii. Magnetic resonance angiography. | |
| Energy Imparted to Patient: Receive-only coils should not impart energy to the patient. | "Both are receive-only MRI antennas so no energy is imparted to the patient." (510(k) Summary, point 6) |
| Compatibility: Interface with specified MRI system. | "Interfaces with the G.E. 1.5 Tesla Excite® system. Utilizes the G.E. Phased Array Coil inputs and utilizes standard coil configuration files available on the G.E. system." (510(k) Summary, point 4) |
| Anatomical Coverage: Expand coverage compared to predicate. | "The intention of the new device is to expand the anatomical coverage provided by the device by modifying the patient-user interface in terms of altering the size and anatomical location of some of the array's individual resonators, as well as adding resonators." (Appendix A) |
| Parallel Imaging Compatibility: New feature added. | "The new device also adds parallel imaging compatibility." (Appendix A) |
Since the submission focuses on demonstrating substantial equivalence through comparison of technical characteristics and intended use, rather than a clinical performance study with AI, the following points are not applicable (N/A) based on the provided text:
- 2. Sample size used for the test set and the data provenance: N/A (No specific test set for performance evaluation is described).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth establishment for a diagnostic performance test is described).
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set requiring adjudication 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: N/A (This is not an AI device, and no MRMC study or human-AI comparison is described).
- 6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: N/A (This is hardware, not an algorithm, and no standalone performance evaluation is described).
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (No diagnostic ground truth is established for performance evaluation).
- 8. The sample size for the training set: N/A (No AI training set is applicable).
- 9. How the ground truth for the training set was established: N/A (No AI training set is applicable).
§ 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.