(16 days)
The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
The Pediatric Body-Cardiac Coil is a phased-array receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Body-Cardiac Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V 0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.
The provided document describes a 510(k) submission for a medical device, a "Pediatric Body-Cardiac Coil." The nature of this device (a receive-only coil for MRI systems) means that its acceptance criteria and the study proving it meets those criteria are focused on its technical performance and safety, rather than on diagnostic accuracy as would be the case for an AI-powered diagnostic tool.
Therefore, the requested information regarding diagnostic performance (e.g., effect size of human readers with AI assistance, sample size for test/training sets for diagnostic accuracy, expert qualifications for ground truth) is not applicable to this type of device.
Below is an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them, tailored to the nature of this MRI coil.
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) summary, the acceptance criteria are primarily related to safety, effectiveness, and substantial equivalence to a predicate device. Performance is framed in terms of achieving these criteria through various tests.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Complies with IEC60601-1 (medical electrical equipment safety standard). |
| Enclosure material (3.5mm thick PC) is UL 94V-0 rated and can withstand highest peak RF voltage up to 4200V. | |
| Effectiveness (Imaging Capability) | "proved to be safe and effective by performance and safety tests". |
| Used for obtaining diagnostic images of pediatric body and cardiac regions in Philips Achieva 3.0T MRI systems. | |
| "yield information that may assist in diagnosis." | |
| Biocompatibility | Bio-compatibility tests were conducted. |
| Substantial Equivalence | "Substantially equivalent to the predicate device in safety and effectiveness." The only difference noted is compatibility with a 3.0T system vs. the predicate's 1.5T system, which is stated "will not result in big difference in their effectiveness" and "does not result in any new potential hazards." |
| Design/Manufacturing | Enclosure material specifically stated: 3.5mm thick PC, UL 94V-0 rated. |
2. Sample size used for the test set and the data provenance
This is not applicable in the context of an MRI coil's technical performance and safety testing. The "test set" would refer to the physical device undergoing various engineering, electrical, and materials tests, not a dataset of patient images for diagnostic performance. The document does not specify the number of coils tested, which is common for such submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, in the context of diagnostic devices, refers to the confirmed diagnostic state of a patient (e.g., presence or absence of a disease). For a passive medical device like an MRI coil, "ground truth" would relate to the accuracy of its technical specifications (e.g., measured RF voltage withstand capacity, material safety ratings), which are typically established through engineering testing and material certifications rather than expert consensus on patient data.
4. Adjudication method for the test set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers when establishing ground truth for diagnostic studies. Since this device is an MRI coil and its performance is assessed via technical tests, there's no diagnostic adjudication in this context.
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
This is not applicable. This device is a passive MRI coil, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance comparison was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated, this is an MRI coil, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance would be derived from:
- Engineering Test Results: Measurements of RF voltage withstand, signal-to-noise ratio (implied by "optimized for high signal-to-noise ratio"), and other electrical properties.
- Material Certifications: UL 94V-0 rating for the PC enclosure.
- Biocompatibility Test Results: Data from tests confirming the materials are biologically safe.
- Compliance with Standards: Verification against IEC60601-1.
8. The sample size for the training set
This is not applicable. There is no "training set" for an MRI coil in the machine learning sense. The design and manufacturing process would involve engineering design, prototyping, and testing, but not a data-driven training set like an AI model.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned above.
§ 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.