(133 days)
iMRX is an integrated imaging system combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging.
The iMRX system uses the Artis zee family of dedicated angiography systems for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the iMRX system include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography and whole body radiographic/fluoroscopic procedures. The iMRX system can also support the acquisition of position triggered imaging for spatial data synthesis.
The iMRX system uses the IMRIS family of Intra-operative MRI systems indicated for use as a magnetic resonance diagnostic device (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the head and whole body. Depending on the region of interest, contrast agents may be used. These images and i or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The iMRX system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The iMRX system may also be used for imaging in a multi-room suite.
The iMRX system is an integrated configuration combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging. The iMRX system is the integration of a Siemens Artis zee family (biplane or floor mounted single plane) and the IMRISheuro System (Neuro III-SV or Neuro II-SE system). The iMRX system is a solution providing MRI scanning capabilities in the Angiography room while retaining all the functionality of Siemens Artis zee system. The iMRX system includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate imaging in multiple rooms. It provides imaging to support intra-operative and interventional capability in the operating room and angio room, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room.
The provided 510(k) summary for the iMRX system is a premarket notification for a medical device and therefore does not contain a study with acceptance criteria and reported device performance in the typical sense of a clinical trial or performance study comparing the device against a defined metric.
Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of defining specific performance metrics (like accuracy, sensitivity, specificity) and then conducting a study to meet those, the manufacturer aims to show that the new device is as safe and effective as devices already on the market.
Therefore, many of the requested points about acceptance criteria, sample size, ground truth, and expert adjudication are not applicable to this type of regulatory submission. The "study" here is primarily a technical comparison and safety assessment against the predicate devices.
Here's an breakdown based on the provided document, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstrated Equivalence to Predicates) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| - Retains all safety features of Siemens Artis zee system (visual & audible warnings). | - "The iMRX system retains all Siemens Artis zee system safety features including visual and audible warnings." - "Testing has been completed to verify the equivalence of iMRX to the Siemens Artis zee system. This assures that the performance of this device can be considered safe and effective with respect to the currently available Siemens Artis zee system." |
| - Adherence to recognized and established industry practice for electrical, mechanical, and radiation hazards. | - "IMRIS adheres to recognized and established industry practice, and all equipment complies with standard performance testing." |
| - Intra-operative features (MRI system, Magnet Mover Assembly, OR Patient Table, Intra-operative Coils, Head Fixation Device) are substantially equivalent to predicate Neuro III-SV and Neuro II-SE. | - "The iMRX intra-operative features... are substantially equivalent to the same intra-operative features of the predicate Neuro III-SV and predicate Neuro II-SE." |
| - Does not raise new safety or effectiveness issues related to a moving MRI system in an intra-operative setting. | - "The iMRX does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting." |
| - MRI imaging system's software and hardware substantially equivalent to Neuro III-SV (based on Siemens MAGNETOM Verio 3T MRI) and Neuro II-SE (based on Siemens MAGNETOM Espree MRI). | - "The iMRX MRI imaging system's software and hardware are substantially equivalent to the Neuro III-SV... System and the Neuro II-SE... system." |
| - Does not raise new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating, or acoustic noise. | - "The iMRX does not raise any new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating or acoustic noise..." |
| - Does not raise new effectiveness issues related to specification volume, signal to noise, image uniformity, geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution as compared to IMRISneuro systems. | - "...or effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution. Testing has been completed to verify the equivalence of iMRX to the IMRISneuro (Neuro III-SV/Neuro II-SE) system. This assures that the performance of this device can be considered safe and effective with respect to the currently available IMRISneuro system." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not describe a test set with patient data for clinical performance evaluation. The "testing" mentioned refers to engineering and quality assurance tests to ensure the integrated system functions as intended and meets safety standards, similar to its predicate devices.
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. As no clinical test set requiring ground truth labeling is described, no experts for this purpose were involved in the context of this submission. The "trained physician" mentioned in the Indications for Use refers to the end-users interpreting the images, not experts establishing ground truth for a study dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication is described in this submission.
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 device is an imaging system (MR and X-ray Angiography), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an integrated imaging system, not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Since no clinical performance study for a diagnostic claim is presented, no ground truth type is specified. The assessment is based on technical equivalence to established predicate devices.
8. The sample size for the training set
- Not Applicable. This is an integrated imaging system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.
§ 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.