(118 days)
Whole body magnetic resonance diagnostic medical device intended for the production of images for diagnostic purposes with transverse, coronal, sagittal and obligue orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence, with limitations regarding cardiac, breast, lung and upper abdominal imaging.
MROpen Evo is a whole body magnetic resonance diagnostic medical device that acquires high-resolution medical images of various parts of the body. In particular, it produces images of the entire body except: upper abdomen, heart, lungs and breasts with transverse, coronal, sagittal and oblique orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence. The standard composition of the MROpen Evo device is: Magnetic Unit Operator PC- Operator PC - Electronic Cabinet - Penetration Filters - Major Software MR GUI-PRO 3.1. Coil set (Body MAX, Hand MAX, Cervical MAX, Knee MAX, Multipurpose Linear, Flat Flex, Spine, Head-Neck, Long Spine, Shoulder) Cushions' Set The device consists of two models. 03-2000-00. The 03-4000-00 model of the MROpen Evo device has a very similar composition to the 03-2000-00 model, but most of the subassemblies that constitute it are replaced with others of equal functionality, in order to reduce production costs. The MROpen Evo device allows the execution of standing imaging for those cases that require this need or facilitates acquisitions on patients suffering from movement disorders or suffering from claustrophobia. It is also possible to undergo this investigation in patients who have a high weight, but in any case, not exceeding 200 kg. The software called MR GU-PRO represents the set of SW modules necessary for the MROpen Evo MR scanner based on the I-box spectrometer. The main modules act as a graphic interface for the execution of the exam. The MR GUI-PRO software has external interface elements, on the one hand the operator who interacts via monitor, keyboard and mouse and the other HW modules of the system and mainly: Gradient Amplifier, RF reception signal amplifier.
The provided text is a 510(k) summary for the MROpen Evo device. It states that the MROpen Evo is "substantially equivalent" to a predicate device, MROpen EVO (K193116). The document describes changes in the subject device, primarily related to an updated spectrometer (I-box 07), a new cryocooler, and the introduction of a "Compressed Sensing" (CS) algorithm for faster MRI acquisition. The acceptance criteria and the study that proves the device meets the acceptance criteria are mainly focused on demonstrating this substantial equivalence.
Here's an breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied for Equivalence) | Reported Device Performance and Evidence |
|---|---|
| Medical Checklist Pass Criteria: Absence of unexpected artifacts, demonstrating equivalence across configurations. | Images rated similar when comparing the three configurations (I-box 07 with CS, I-box 07 without CS, and the predicate's configuration). No artifacts were found due to new characteristics. |
| Software Performance: Limited reconstruction errors and no introduction of artifacts compared to standard processing. | "CS software module shows limited recontruction errors and does not introduce artefacts in image processing that does not use this reconstruction algorithm." Analysis showed predicate and MROpen Evo software performances are substantially equivalent. |
| Biocompatibility: Not cytotoxic, not irritant, not sensitizing. | Testing results confirmed the samples in their finished form are: Not cytotoxic, Not irritant, Not sensitizing. |
| Electrical Safety and EMC: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 62471. | Testing results are positive; no "fail" result appears on the test reports. |
| Software Verification and Validation: Compliance with IEC 62304 and FDA guidance for software. | All test results are "Passed." Analysis showed predicate and MROpen Evo software performances are substantially equivalent. |
| Performance and Safety: Equivalent acoustic noise, unchanged electromagnetic characteristic of inner part of the magnetic unit, equivalent gradient output, equivalent Specific Absorption Rate (SAR), equivalent dynamic forces on patient support. | Analysis of performance data demonstrates that the legally marketed Predicate Device performances are substantially equivalent for the assessed endpoints. |
| Usability: Compliance with IEC 60601-1-6 and IEC 62366-1. | Testing results are positive; no "fail" result appears on the test reports. This demonstrates safety, effectiveness, and substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The "medical checklist" and "in vivo" testing for the Compressed Sensing algorithm are mentioned. For the in vivo testing, it states "comparing the and without undersampling," implying a comparison of images. It does not provide the number of patients or images used for this comparison.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal to ASG Superconductors S.p.A. The "in vivo" testing suggests prospective data collection in a clinical setting, but the details are sparse.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The evaluation of image similarity and artifact absence was likely performed by qualified personnel, but their number and specific qualifications are not specified.
4. Adjudication Method for the Test Set
- This information is not provided in the document. The process for rating images and determining "similarity" or "absence of artifacts" is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study is not explicitly mentioned. The document focuses on demonstrating "substantial equivalence" of the device itself (hardware and software), rather than a comparative effectiveness study of human readers with vs. without AI assistance. The "in vivo" testing compares images produced by the device under different configurations, not human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a form of standalone performance evaluation was conducted for the Compressed Sensing (CS) algorithm. The text states:
- "Compressed Sensing algorithm was tested in vivo, comparing the and without undersampling. The images were rated similar when comparing the three configurations artifacts were found due to the new characteristics implemented."
- "the introduction of CS software module shows limited recontruction errors and does not introduce artefacts in image processing that does not use this reconstruction algorithm."
This indicates an assessment of the algorithm's output (images) without necessarily involving human interpretation in a diagnostic workflow comparison.
7. Type of Ground Truth Used
- For the "medical checklist" and "in vivo" testing of image quality (artifacts, similarity): The ground truth appears to be based on expert consensus/visual assessment of image quality and the presence or absence of artifacts. This is inferred from statements like "images were rated similar" and "no artifacts were found."
- For other non-clinical tests (biocompatibility, electrical safety, software V&V, performance & safety, usability): The ground truth is based on compliance with recognized international standards (e.g., ISO 10993, IEC 60601, IEC 62304, IEC 62366) and the specific criteria outlined within those standards.
8. Sample Size for the Training Set
- This information is not provided in the document. The document describes the testing of the device and its algorithms, but not the development or training of any machine learning components. While the Compressed Sensing algorithm might involve learned parameters, the training data details are not disclosed.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided as the details of any algorithm training are absent from the document.
§ 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.