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510(k) Data Aggregation
(25 days)
The IMRIS Neuro II-S MRI system is indicated for use for the whole body. The Neuro II-S is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. correspond to the distribution of protons exhibiting MR characteristics; 2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and 3. display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Neuro II-S may also be used during intra-operative procedures when performed in an intra- operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The IMRIS Neuro II-S Intra-operative MRI system is a traditional 1.5T MRI system that has been suspended from an overhead gantry to facilitate intra-operative use. The main components of the Neuro II-S system are the MRI system assembly ( including diagnostic RF coils), the magnet mover assembly, the OR patient table assembly and the intra-operative RF coil.
The provided text is a 510(k) summary for the IMRIS Neuro II-S Intra-operative Magnetic Resonance Imaging System, focusing on its substantial equivalence to previously marketed devices. It describes the device's technical specifications and indications for use. However, this document does not contain an "acceptance criteria and study that proves the device meets the acceptance criteria" as typically expected for demonstrating clinical performance or diagnostic accuracy.
The provided document describes a substantial equivalence determination process, where the new device (Neuro II-S) is compared to legally marketed predicate devices primarily based on design, intended use, and safety/effectiveness considerations. The "study" mentioned is laboratory testing to verify equivalence to the Siemens Magnetom Symphony System and to verify safe and effective intra-operative operation. This is a technical performance verification rather than a clinical study evaluating diagnostic performance against specific acceptance criteria.
Therefore, many of the requested information points, especially those related to clinical performance, expert ground truth, and statistical significance, are not applicable or not present in this type of regulatory submission.
Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated or implied) |
|---|---|
| Equivalence to Predicate Devices: | Equivalence to Predicate Devices: |
| - Intra-operative features (Magnet Mover Assembly, OR Patient Table, Intra-operative RF Coil) are substantially equivalent to Neuro II. | "The Neuro II-S intra-operative features ... are substantially equivalent to the same intra-operative features of the Neuro II." |
| - Software and hardware (except Intra-operative RF Coil and Patient Table) are substantially equivalent to Siemens Magnetom Symphony 1.5T MRI system. | "The Neuro II-S MRI system's software and hardware... are substantially equivalent to the Siemens Magnetom Symphony 1.5T MRI system." |
| - Intra-operative RF Coil design is substantially equivalent to the Picker Large Joint Coil (with modifications for use in OR). | "The Neuro II-S Intra-operative RF Coil design is substantially equivalent to the Picker Large Joint Coil..." |
| Safety and Effectiveness (Absence of New Issues): | Safety and Effectiveness (Absence of New Issues): |
| - Does not raise new safety/effectiveness issues related to moving MRI system in intra-operative setting. | "The Neuro II-S does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting." |
| - Does not raise new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating, or acoustic noise. | "The Neuro II-S 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. | "...or effectiveness issues related to specification volume, signal to noise, image uniformity, geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution." |
| Verification of Operation: | Verification of Operation: |
| - Safe and effective intra-operative operation. | "Laboratory testing has been completed to verify... the safe and effective intra-operative operation of the Neuro II-S." |
Note: This table reflects the nature of a 510(k) submission, which often relies on demonstrating substantial equivalence rather than defining and meeting specific quantitative clinical performance acceptance criteria through prospective clinical trials. The "performance" here is largely an assertion of equivalence and absence of new issues, supported by laboratory testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "laboratory testing" for verification but does not detail the size or nature of any "test set" in the context of clinical images or patient data.
- Data Provenance: Not specified.
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)
- Number of Experts: Not applicable. The document does not describe the establishment of ground truth by experts for a clinical test set. The evaluation focuses on technical equivalence and safety/effectiveness, not diagnostic accuracy.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No clinical test set requiring expert adjudication is described.
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
- MRMC Study: No. The document does not describe an MRMC study. This device is an imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. The Neuro II-S is an MRI system, which produces images for interpretation by a trained physician. It is not an autonomous algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for the substantial equivalence claim is effectively the performance and safety characteristics of the predicate devices and the results of laboratory testing validating the new device's technical specifications.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As an MRI system, the Neuro II-S is not an AI algorithm that undergoes a "training" process with a dataset in the typical machine learning sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable (see point 8).
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