(13 days)
To be used in conjunction with Magnetic Resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
The NeoCoil 1.5T 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout. The submitted device consists of semi-flexible foam covered housing, consisting of eight antennas. The antennas are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas or decoupled from an adjacent antenna using a transformer. Pre-amplifier decoupling reduces any remaining decoupling between the antennas. The coil is held in place over the imaging area via a cross body strap. A system interface cable connects to the coil at the top of the housing. The flexible foam covered housing along with the body strap enable the proper positioning on the patient before laying down and holds the coil in place while scanning is being performed. To ensure safety, each antenna is equipped with two transmit decoupling circuits; one active and the other passive. Active decoupling is achieved by PIN diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. The passive switched diodes detune the antennas further during RF transmit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NeoCoil 1.5T 8-Channel Shoulder Array Coil:
It's important to note that the provided text is a 510(k) summary for a medical device (an MRI coil), not an AI algorithm. Therefore, many of the requested categories related to AI performance, ground truthing, and expert review are not applicable or explicitly mentioned in this type of submission. The focus here is on hardware performance and safety compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1, IEC 60601-2-33, and general medical device safety requirements (no new potential hazards, does not alter MRI scanner safety). | Each antenna equipped with active (PIN diodes) and passive (crossed diodes) transmit decoupling circuits. |
| Image Quality (SNR) | Substantially equivalent or superior to predicate devices (specifically Invivo Corp. 8-Channel Shoulder Array and Medical Advances Inc. 4-Channel Shoulder Coil). | "Submitted device offers greater SNR due to its unique eight channel layout." |
| Image Quality (Uniformity) | Satisfies design objectives, comparable to predicate devices. | "Image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives." |
| Field-of-View (FOV) | Larger or comparable to predicate devices. | "Larger field-of-view due to the antenna layout." |
| Functionality | Suitable for obtaining diagnostic images of the shoulder that can be interpreted by a trained physician. | Designed as a multi-element phased array receive-only coil for imaging the shoulder. |
| Mechanical/Physical Design | Semi-flexible foam covered housing, eight antennas, appropriate overlap to cancel mutual coupling, pre-amplifier decoupling, cross-body strap for positioning. | Described features match the design. |
| Substantial Equivalence | Overall determination of substantial equivalence to predicate devices (Invivo K053017 and Medical Advances K021433). | "In all material respects, the NeoCoil 1.5T 8-Channel Shoulder Array is substantially equivalent to the Invivo Shoulder coil Assembly." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The summary mentions performance testing related to SNR and image uniformity but does not specify the number of subjects, scans, or the nature of the data (e.g., phantom, in vivo, retrospective/prospective, country of origin). This type of detail is typically found in the full submission, not the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is largely not applicable in the context of an MRI coil 510(k) submission. The "ground truth" for a medical device like an MRI coil is its physical performance (SNR, uniformity, safety), not an interpretation of images by experts to create a diagnostic ground truth. The "interpretation by a trained physician" is part of the intended use, implying the images produced are clinically usable, which is assessed through the performance metrics.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for this type of device submission. Adjudication methods are relevant for diagnostic AI algorithms where expert consensus resolves discrepancies in image 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
No, an MRMC comparative effectiveness study was not done. This device is an MRI coil, a hardware component, not an AI algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is a hardware device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance assessment appears to be based on:
- Quantitative measurements: For SNR, likely using established phantom protocols (as per NEMA MS-6) and potentially in vivo measurements.
- Image uniformity assessment: Likely through specific phantom scans and potentially clinical image review against visual standards or quantitative metrics.
- Safety testing: Compliance with IEC standards, evaluation of decoupling circuits, and potential in-vitro safety tests (e.g., heating).
- Comparison to predicate devices: The functionality and performance are benchmarked against other legally marketed MRI shoulder coils.
It is not based on expert consensus, pathology, or outcomes data related to diagnostic accuracy in the way an AI algorithm's performance would be. The "ground truth" is about the physical and imaging characteristics of the coil itself.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This is a hardware device, not an AI algorithm, so there is no training set in the machine learning sense. The device developers would have performed internal testing and optimization during the design and manufacturing process, but this is not referred to as a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the same reasons as #8.
§ 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.