(22 days)
The intended use for this 1.0T 8-channel Neurovascular Coil is to facilitate diagnostic targeting imaging of brain, neck and upper chest that may be interpreted by a trained physician.
- To collect image data throughout the region of the head, neck and chest region of the patient using a Philips vertical-field 1.0T MR scanner.
- Various regions of the Brain, including brainstem, pituitary, IAC, and orbits, intra cerebral vascular structure, soft tissue of the facial area, arteries between the aortic arch and the Circle of Willis, soft tissue in the anterior neck, pediatric head/neck, cervical spine, long top and brachial plexus, and with the ability to scan feet and ankles.
The 8 individual coils that comprise the ST SENSE NV 8 Array Coil (Neurovascular Array) interface with a 1.0 Tesla, 8-channel Panorama MRI scanner. Between the device and its predicate, there are slight variations in physical size of electrical and physical aspects (to accommodate focus of anatomies) The designs and materials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a rigid housing that disconnects to facilitate both close coupling of the imaging coil's regionof-sensitivity to the anatomy of interest on a patient anatomy, and ease of entry to each patient. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry.
The provided text describes a 510(k) summary for the ST SENSE NV 8 Array Coil, an MRI coil, and focuses on demonstrating its substantial equivalence to a predicate device. The information presented is primarily for a medical device regulatory submission and does not detail a study proving the device meets acceptance criteria in the format typically used for AI/algorithm performance.
Here's an analysis based on the provided text, structured to address your requested information points, but with the caveat that many points are not applicable (N/A) as the document is not about AI/algorithm performance.
Device: ST SENSE NV 8 Array Coil (MRI coil)
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for performance metrics that would be applicable to an AI device. Instead, it describes a "substantial equivalence" comparison to a predicate device based on design, materials, chemical composition, energy source, and non-clinical tests.
| Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance |
|---|---|
| Design: Receive-Only Coil for MRI System, 8-channel, diagnostic quality images, angiography capability of brain to lung tops. | "very similar anatomy" to predicate, "8-channel receive coil with all channels designed to work at once, in conjunction with the system Body Coil." "may give diagnostic quality images of the tops of the lungs all the way to the brain, with angiography of the entire anatomy within this range." |
| Material: Biocompatible (polycarbonate with enamel paint), insulting qualities (dielectric withstand testing), liquid ingress resistance. | "largely polycarbonate, painted, and with Ultem latching pieces." "distinction between the predicate and current submission is non-substantive in that they both have insulating qualities proven by dielectric withstand testing, and have passed liquid ingress testing." |
| Chemical Composition: Biocompatible construction. | "biocompatible construction, using polycarbonate with enamel paint, as demonstrated by cytotoxicity testing and by their history of use in previously cleared devices." |
| Energy Source: Receive-only, stimulated by MRI system. | "receive-only coils not generating their own power, but rather stimulated by the MRI system as the energy source." |
| Non-Clinical Tests: | Passed. "compared by similar risk management efforts," "determined to be substantially equivalent." Includes: Sensitivity profile, SNR Analysis, Hazard Analysis, FMEA, Blocking Analysis, Heat Tests. |
| Clinical Tests (Image Quality): Substantial equivalence in imaging brain and neck regions (for predicate) and brain to lung tops (for subject device), across sagittal, coronal, and transverse planes. | "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." |
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 mentions "Analyses in all 3 planes (sagittal, coronal and transverse) were run" for "Clinical Tests," but it does not specify the sample size (number of patients or scans), data provenance, or whether the study was retrospective or prospective.
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. This device is an MRI coil, not an AI/algorithm that requires expert-established ground truth for its performance evaluation in the typical sense. The images are "interpreted by a trained physician," but this refers to the end-user clinical interpretation, not the establishment of ground truth for evaluating the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The clinical tests described involve comparing image quality of anatomical regions to a predicate device, not an adjudication process for diagnostic interpretations.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the typical sense for an AI/algorithm. The "ground truth" for this device's performance is essentially the ability to produce diagnostic quality images of specified anatomical regions, which is compared to a predicate device and assessed by evaluating sensitivity profiles, SNR, and image clarity across planes. This is a functional and safety evaluation, not a diagnostic accuracy evaluation against a ground truth diagnosis.
8. The sample size for the training set
Not applicable. This is a physical medical device (MRI coil), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described is a regulatory submission demonstrating substantial equivalence of the ST SENSE NV 8 Array Coil to a legally marketed predicate device (1.5T Pediatric Head/Spine Array Coil). This is a standard pathway for medical device clearance in the US, indicating that the new device is as safe and effective as the predicate.
The evidence presented includes:
- Comparison of Technological Characteristics:
- Design: Both are receive-only coils for MRI systems, with the subject device being an 8-channel coil capable of imaging brain, neck, and upper chest, with angiography. The predicate covers "very similar anatomy" but for a different system and field strength.
- Material: Both use biocompatible polycarbonate with enamel paint and Ultem latching parts, with proven insulating qualities and liquid ingress resistance.
- Chemical Composition: Both are biocompatible.
- Energy Source: Both are receive-only, stimulated by the MRI system.
- Non-Clinical Tests: The new device was compared using "similar risk management efforts" to the predicate, including Sensitivity profile, SNR Analysis, Hazard Analysis, FMEA, Blocking Analysis, and Heat Tests. These tests "determined to be substantially equivalent."
- Clinical Tests (Image Quality Comparison): "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 images the complete brain and neck regions, while the new device images anatomies between the brain and lung tops. The "Final Discussion" reiterates that the device "is as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies."
In essence, the "study" is a comprehensive engineering and performance comparison against a predicate device, focusing on safety and efficacy markers relevant to an MRI coil's operation and imaging capabilities, rather than a clinical trial measuring diagnostic accuracy against a definitive ground truth.
§ 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.