(32 days)
The family is to be used in conjunction with a GE 1.5T and GE 3.0T Magnetic Resonance Scanner, to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions that can be interpreted by a trained physician.
The intended use for the device family is to provide MRI antenna sets to facilitate targeting imaging of the orbit region and mandible region.
Tissue of the brain and face with emphasis on the orbits, and of the mandible joint of the head.
The devices are a 1.5T Orbit and Mandible Array and a 3.0T Orbit and Mandible Array. The designs and materials used to manufacture each coil are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing is formed by an EVA foam cover around a flexible circuit board. The two devices in this family are identical except for the tuned frequency.
The provided text is a 510(k) summary for the "Orbit and Mandible Array Family" MRI coils. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, many of the requested sections about clinical studies, reader studies, and ground truth establishment are not applicable or cannot be extracted from this document.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence to a predicate device based on design, materials, chemical composition, energy source, and non-clinical tests. The "performance" is implicitly deemed acceptable if it's "as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies."
| Performance Metric (Implicit) | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | As safe and effective as the legally-marketed predicate device (Pediatric Array Coil K951649) | "the study determines that the submitted device is as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies." This is based on non-clinical tests including Sensitivity Profile, SNR Analysis, Hazard Analysis, FMEA, Blocking Analysis, and Heat Tests. The design also emphasizes smaller dedicated loops closer to the patient's face, offering no energy source, and exhibiting strong decoupling, implying enhanced safety and effectiveness for its specific target anatomies compared to a broader brain coil. The document also states, "The coils have similar dimension in the head area and have induced similar fields by the transmit coils that stimulate them. The predicate and current submission were compared by similar risk management efforts, as listed below, and determined to be substantially equivalent." |
| Image Quality | Ability to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions. | "Analyses in all 3-planes (sagittal, coronal and transverse) were run to show that the anatomies of the submitted and predicate coils have substantial equivalence; the predicate device images the complete brain including orbits, and the Orbit & Mandible Family submission simply dedicates to a more local, higher-resolution performance on the orbits and mandible." This implies the images are of diagnostic quality, and for the target regions, potentially higher resolution. |
| Biocompatibility | Biocompatible construction | "Both products, the predicate and the recent submission, have biocompatible construction as demonstrated by cytotoxicity testing and by their history of use in previously cleared devices." |
| Insulation | Insulating qualities proven | "The distinction between the predicate and Orbit & Mandible Family group is non-substantive in that they both have insulating qualities proven by dielectric withstand testing, and have passed liquid ingress testing." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical tests and comparisons to a predicate device, rather than a clinical study with a "test set" in the context of an AI/algorithm validation. The "analyses in all 3-planes" mentioned under clinical tests refer to showing substantial equivalence in imaging capabilities, not a study involving patient data with a defined sample size for performance evaluation. No sample size for a test set is provided, and thus, data provenance cannot be determined.
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)
Not applicable. The document discusses device characteristics and equivalence, not an AI/algorithm where ground truth would be established by experts for a test set. The images are intended to be "interpreted by a trained physician," but this refers to the end-user clinical interpretation, not ground truth establishment for a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring ground truth 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
Not applicable. This is a submission for MRI coils, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (MRI coil), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the ability of the coil to produce diagnostic images, which is assessed through non-clinical performance characteristics and comparison to a predicate device's established performance.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.