(15 days)
To be used in conjunction with 3.0T GE HD series Magnetic Resonance scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
The NeoCoil 3.0T 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 easier patient setup and greater SNR due to its compatibility with 3.0T MRI scanners.
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 active and passive transmit decoupling circuits. Active decoupling is achieved via 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. These passive switches provide additional safety in case the active circuitry does not receive signal from the scanner.
The NeoCoil 3.0T 8-Channel Shoulder Array Coil is a multi-element phased array receive-only coil designed for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. The provided 510(k) summary outlines the device's technical specifications and a study supporting its substantial equivalence to predicate devices. However, it does not fully detail all the requested information regarding a clinical study with detailed acceptance criteria and expert ground truth establishment for diagnostic performance.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The submission focuses on "substantial equivalence" to predicate devices rather than establishing specific clinical diagnostic performance acceptance criteria for the new coil itself. The key performance metrics mentioned are Signal-to-Noise Ratio (SNR) and image uniformity. The document implies that if these are comparable or better than predicate devices, the device is acceptable for its intended use of producing diagnostic images.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| SNR (Signal-to-Noise Ratio) | Testing performed which supports conclusion that the device satisfies design objectives (implied comparable/better than predicate) |
| Image Uniformity | Testing performed which supports conclusion that the device satisfies design objectives (implied comparable/better than predicate) |
| Safety | Use of the device does not result in any new potential hazards and does not alter the safety of the MRI scanner |
| Compatibility | To be used with 3.0T GE HD series Magnetic Resonance scanners |
It is important to note that the document does not provide specific numerical targets or results for SNR and image uniformity. It states that "SNR and image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives" and that the device is "substantially equivalent" to predicate devices. This indicates a comparative assessment rather than an absolute performance threshold.
Study Details for Device Performance
Based on the provided K071611 document:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of clinical images or diagnostic cases. The performance study mentioned relates to technical performance (SNR and image uniformity) of the coil itself, likely conducted in a lab setting rather than with patient data. Therefore, details about data provenance or a patient-based test set are not provided. -
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, as the performance testing described is technical (SNR, image uniformity) and does not involve diagnostic interpretation by experts or a clinical ground truth for a test set. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as there is no mention of a diagnostic test set requiring expert adjudication. -
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. This device is a passive MRI coil and does not incorporate AI. The study described is a technical comparison to predicate devices, not a clinical multi-reader study. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device (MRI coil), not an algorithm. Its "standalone" performance refers to its physical and electromagnetic characteristics. The document indicates that technical testing (SNR, image uniformity) was performed on the coil itself to demonstrate its operational characteristics. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the technical performance aspects (SNR and image uniformity), the "ground truth" would be established by physical measurements and engineering specifications, often compared to the performance of predicate devices or industry benchmarks. There is no mention of clinical ground truth (e.g., pathology, clinical outcomes) as the study was not a clinical diagnostic efficacy trial. -
The sample size for the training set:
Not applicable. This device is a hardware component. There is no "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on engineering principles and prototypes. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this hardware device.
Summary of the Study type:
The "Summary of Studies" section in the K071611 document indicates that "SNR and image uniformity testing was performed" to support the conclusion of substantial equivalence. This implies that the study was primarily a technical bench study comparing the performance of the NeoCoil 3.0T 8-Channel Shoulder Array Coil with existing predicate devices (USA Instruments Inc. Mark III Phased Array Shoulder Coil (K042009) and NeoCoil 1.5T Shoulder Array Coil Model NC008 (K071311)). The objective was to demonstrate that the new device meets its design objectives and does not introduce new safety concerns compared to legally marketed devices. The review determined that "Use of the NeoCoil 3.0T 8-Channel Shoulder Array does not result in any new potential hazards and does not alter the safety of the MRI scanner."
In essence, for this 510(k) submission, the "acceptance criteria" and "study" are focused on demonstrating technical equivalence (specifically in SNR and image uniformity) and safety to existing devices, rather than a clinical efficacy study with diagnostic endpoints.
§ 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.