(30 days)
The 3.0T Prostate Imaging System is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate gland and surrounding pelvic tissue. The 3.0T Prostate Imaging System is intended for use with Siemens 3.0T Trio scanner platforms only. Only trained healthcare professionals are intended to operate this device.
The MEDRAD 3.0T Prostate Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate devices. The device is a receive-only surface coil.
The provided text is a 510(k) summary for the MEDRAD 3.0T Prostate Imaging System. This document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found for a novel device or software. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods is not present in this type of submission.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a new device performing a diagnostic task. Instead, the "acceptance criteria" are implied by the comparison to predicate devices, focusing on maintaining similar intended use, operational parameters, and safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| Receive-only coil type maintained | Receive-only surface coil. |
| Region of Interest maintained (prostate gland and pelvic tissue) | Prostate gland and surrounding tissue. |
| Fixed tuning in production | Fixed tuning set in production. |
| Compatibility: | |
| Compatible with 3.0T MRI scanner platforms | Compatible with 3.0T MRI scanner platforms. |
| Compatible with Siemens 3.0T Trio MRI scanners | Compatible with Siemens 3.0T Trio MRI scanners. |
| Safety: | |
| Patient-contacting materials similar to predicate | Outer balloon (Natural Latex), Shaft (PVC), Shrink tubing (Teflon (FEP)), Migration stop (PVC) are the same as predicate. |
| Operational Parameters: | |
| Decoupling mechanism (passive; active and passive in interface) | Passive (endorectal coil); active and passive (interface device). |
| RF Signal Pre-Amplification performed by interface device | Performed by the interface device. |
| Endorectal Coil Inner Balloon Inflation Compatibility (Air/fluid) | Air or fluid. |
2. Sample size used for the test set and data provenance:
- Not Applicable / Not Provided. This document is for a physical medical device (an MRI coil), not an AI/software device. There is no "test set" in the context of diagnostic performance or algorithmic evaluation. The evaluation is based on engineering specifications and comparison to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. See point 2.
4. Adjudication method for the test set:
- Not Applicable / Not Provided. See point 2.
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 / Not Provided. This device is a passive MRI coil and does not incorporate AI. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance would be relevant or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This device is a physical MRI coil and does not involve any algorithms.
7. The type of ground truth used:
- Not Applicable / Not Provided. As this is a physical medical device (an MRI coil), the "ground truth" concept in the context of diagnostic accuracy is not directly applicable. The evaluation relies on engineering specifications, material compatibility, and performance characteristics (e.g., signal reception quality, compatibility with scanner).
8. The sample size for the training set:
- Not Applicable / Not Provided. See point 2 and 6.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. See point 2, 6, and 8.
Summary of Device and Approval Basis:
The MEDRAD 3.0T Prostate Imaging System is a receive-only magnetic resonance coil intended for high-resolution MRI and spectroscopy of the prostate gland. Its approval (K051349) was based on substantial equivalence to existing predicate devices: the MEDRAD MRInnervu Endorectal Prostate Coil (K926571) and the MEDRAD Flex Interface Device (K971380).
The primary differences and the basis for establishing equivalence were:
- Operating field strength: The new device is designed for 3.0T MRI scanners, whereas the predicates were for 1.5T.
- Scanner compatibility: Siemens 3.0T Trio MRI scanners for the new device, compared to Siemens Vision 1.5T MRI scanners for the predicates.
- RF Signal Pre-Amplification: The new device performs pre-amplification in the interface device, while the predicate relied on the scanner.
- Endorectal Coil Inner Balloon Inflation Compatibility: The new device allows for air or fluid, while the predicate only specified air.
The submission confirms that the intended use, operational parameters, and patient-contacting materials (natural latex, PVC, Teflon) are similar to or equivalent to the predicate devices, thereby ensuring safety and effectiveness for its specified use. The FDA deemed this sufficient for 510(k) clearance, indicating that detailed performance studies related to diagnostic accuracy (as would be seen for AI/software) were not required given the nature of the device and the substantial equivalence claim.
§ 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.