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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

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.

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MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

Like the previously cleared device K190524, the actual MRopen EVO is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.

Modification of K190524 cleared device.

• . New commercial name (hence labeling is amended)
• . Different cover colours from light blue to grey
• . Changes in labelling due to above changes

MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

This FDA 510(k) summary for the MRopen EVO device states that no new testing was performed to establish acceptance criteria or device performance, as the changes from the predicate device (MRopen 0.5 T, K190524) were limited to a new commercial name and different cover colors. The submission relies entirely on the safety and effectiveness data provided for the predicate device.

Therefore, many of the requested details cannot be extracted directly from this document regarding the MRopen EVO. However, based on the information provided, we can infer the following about the approach taken for the MRopen EVO and, by extension, the predicate device it references:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format for the MRopen EVO. Instead, it asserts substantial equivalence to the predicate device (MRopen 0.5 T, K190524) because the changes are only cosmetic (name and color). The performance is therefore assumed to be identical to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided for the MRopen EVO or explicitly detailed for the predicate device within this summary. The summary states that "non clinical (bench) and clinical (healthy volunteers) data supplied within K190524 file" were used.

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)

This information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

The MRopen EVO is a magnetic resonance diagnostic device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI-assisted reading would not be applicable or expected for this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The MRopen EVO is a medical imaging device, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly provided. The summary mentions that images produced by the device "can yield information that can be useful in the determination of a diagnosis" when interpreted by a "trained physician," implying that clinical diagnosis by qualified medical professionals would establish ground truth for the predicate device's performance.

8. The sample size for the training set

This information is not applicable as the MRopen EVO is an imaging device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable.

Summary of the Acceptance Criteria and Study for MRopen EVO based on the provided document:

Conclusion:

This 510(k) submission for the MRopen EVO is a Special 510(k) primarily focused on demonstrating substantial equivalence to its predicate (MRopen 0.5 T, K190524) based on the limited nature of the proposed changes (commercial name and cover colors). Consequently, the document explicitly states that no new non-clinical or clinical testing was deemed necessary. All safety and effectiveness claims for the MRopen EVO rely on the data previously submitted and reviewed for the predicate device. Therefore, this document does not contain the detailed study information (sample sizes, expert qualifications, ground truth methods, etc.) that would typically be found for a device undergoing de novo testing or significant modifications.

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MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

Like the previously cleared device K151466, the actual MRopen 0.5 T is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.

Modification of K151466 cleared device.

• Introduce DWI technique based on HASTE readout sequence 0
• Introduce internally developed User Interface 0
• Introduce changes in hardware such as spectrometer, compressors and cold heads, 0 RFA
• 0 Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils)
• Long Spine receiving coil o
• 0 Shoulder coil new model
• Changes to patient support shapes and courtesy cushions o

MRopen 0.5 T is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position.

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The modification reflected in this Traditional 510(k) for the MRopen 0.5 T Tomograph are to introduce updates in hardware and software including the DWI technique previously not released. The modifications have not altered the scientific technology of the unmodified version MrOpen K151466 as detailed in below table.

The provided text describes modifications to an existing MRI device (MRopen 0.5 T) and its substantial equivalence to predicate devices, focusing on hardware and software updates, including the introduction of a DWI technique. However, it does not explicitly detail the acceptance criteria for these modifications or a specific study proving the device meets those criteria in the way typically required for a classification of an AI/ML-enabled medical device.

The document states "No clinical tests were performed" for the purpose of demonstrating substantial equivalence in the conventional sense. Instead, it refers to images of healthy volunteers to demonstrate the performance of the device on humans for the new DWI technique and new coils.

Here's an attempt to extract the requested information based on the provided text, acknowledging the limitations for certain points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria typical for complex AI/ML device performance. Instead, it discusses image quality and performance in a qualitative manner, referencing clinical utility and comparison to predicate devices for specific features.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: "The healthy volunteers were adult male and female aged between 20 and 60 available in our firm." The exact number is not specified, but it implies a small, internal cohort.
• Data Provenance: The healthy volunteers were "available in our firm," suggesting internal, prospective data collection from individuals affiliated with the company. The country of origin is presumably Italy, where ASG Superconductors S.p.A. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not specified. The document states, "When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis." This implies interpretation by a physician but does not detail the number or role of experts in establishing ground truth for the test set explicitly.
• Qualifications of Experts: Assumed to be "trained physician(s)" as stated in the intended use. Specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set

• Adjudication method: Not specified. Given the qualitative nature of the "results/remarks," it's unlikely a formal adjudication method was employed as would be typical for an AI/ML diagnostic system. The evaluation seems to be based on direct assessment of image quality and clinical utility.

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

• A MRMC comparative effectiveness study was not performed, nor is it applicable to this submission. The device is a diagnostic imaging system (MRI), not an AI-assisted diagnostic tool for image interpretation. The submission is for hardware and software updates to an existing MRI machine.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• A standalone algorithm performance study was not performed, nor is it applicable. This is an MRI system, which produces images for physician interpretation, not an algorithm that provides a standalone interpretation or diagnosis.

7. The Type of Ground Truth Used

• For the performance evaluation of the DWI technique and new coils, the "ground truth" was qualitative assessment of image quality from healthy volunteers compared to expected diagnostic image quality from established techniques and coils. It is not based on pathology, outcomes data, or formal expert consensus in the typical sense of a diagnostic study for a specific condition.

8. The Sample Size for the Training Set

• The document describes the submission as updates to an existing MRI system and the introduction of a DWI technique. It does not refer to an AI/ML model that requires a "training set" in the conventional sense. Therefore, information on a training set size is not applicable/not provided.

9. How the Ground Truth for the Training Set was Established

• As there is no mention of an AI/ML algorithm or training set, this information is not applicable/not provided. The "HASTE readout sequence" mentioned for DWI is a specific MR imaging pulse sequence, not a machine learning algorithm.

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MrOpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging, MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the examinations may be performed both in weight free (supine or seated position) and weight bearing position.

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (72), chemical shift and flow velocity. When interpreted by a trained physician, these images en yield information that can be useful in the determination of a diagnosis,

Like the previously cleared device K101295, the actual MROpen 05 is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.

Modification of K101295 cleared device.

• . Remove the angiography limitation,
• . update software by adding a new angiography sequence and 3D viewer tool,
• update the receiving coils' set including some new coils. .

MROpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position.

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

The provided text describes a 510(k) premarket notification for the MrOpen 05, a Magnetic Resonance Diagnostic Device. The submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with predefined endpoints.

Therefore, much of the requested information regarding acceptance criteria, specific study design (sample size, data provenance, ground truth, adjudication, MRMC study), and training set details are not explicitly present in the provided text, as these are typically part of a more extensive clinical trial report.

However, based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" but focuses on demonstrating that the new angiography sequence and coils provide expected image quality and performance equivalent to or better than the predicate devices. The "reported device performance" is qualitative.

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: "healthy volunteers" (number not specified, but plural indicates more than one).
• Data Provenance: The healthy volunteers were "available in our firm," suggesting prospective data collection at the company's location (likely Italy, given the submitter's address).

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 specified.
• Qualifications of Experts: The document states that the images are "interpreted by a trained physician," but no specific details about the number or qualifications of physicians involved in establishing ground truth for this particular demonstration are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

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 Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence, not reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable, as this is a medical imaging device (MRI scanner), not an algorithm-only device. The device produces images that are then interpreted by a trained physician.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the non-clinical tests (bench testing for standards) and healthy volunteer imaging: The "ground truth" for the new angiography sequence was qualitative, based on whether the images conformed to "expected image quality." For the new coils, it was assessed as "equivalent or better quality image, or patient comfort" compared to previous models. This suggests a form of expert visual assessment or comparison rather than a strict pathologist-confirmed or outcomes-based ground truth.

8. The sample size for the training set

• The document describes testing and comparison against predicate devices, not the training of an AI algorithm. Therefore, "training set" is not applicable in this context. The device's performance relies on its inherent hardware and software design, which would have been developed and refined (analogous to 'training') during its engineering phase, but not in the sense of an algorithmic training set with ground-truth labels.

9. How the ground truth for the training set was established

• Not applicable, as explained above.

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The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging.

MR Open tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the body.

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

The MR parameters that determine image appearance are proton density, spinlattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The MrOpen 05 MRI system is substantially equivalent to Paramed MrOpen K073362 as a total body open structure superconducting MRI Scanner.

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of specific performance metrics.

This document is a 510(k) summary for a medical device (MrOpen 05 MRI system). 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance studies with statistical analysis as might be done for a novel device or a device with new performance claims.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: The document lists IEC, UL, and FDA standards as compliance targets, but these are general safety and performance standards for MRI devices, not specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for a particular condition). There is no table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample Size and Data Provenance (Test Set): No information about a test set, its sample size, or data provenance is provided.
• Number of Experts and Qualifications (Ground Truth): No information about experts used to establish ground truth is mentioned.
• Adjudication Method: No adjudication method is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of an MRMC study or any comparison of human readers with vs. without AI assistance. This device is an MRI scanner, not an AI-assisted diagnostic tool.
• Standalone Performance: As this is an MRI scanner, its "standalone performance" would relate to image quality parameters, signal-to-noise ratio, spatial resolution, etc., which are often demonstrated through technical evaluations and phantom studies rather than diagnostic performance studies in a 510(k) summary. However, these specific details are not provided here.
• Type of Ground Truth: No specific ground truth type (e.g., pathology, outcomes data, expert consensus) is discussed for any performance evaluation.
• Sample Size for Training Set: There is no mention of a training set, as this is a hardware device, not a machine learning algorithm.
• How Ground Truth for Training Set was Established: Not applicable, as there's no training set mentioned.

In summary, the provided document focuses on regulatory compliance (510(k) process) and establishing substantial equivalence to a predicate MRI device. It does not contain the detailed performance study information requested, which would typically be found in clinical study reports for devices making specific diagnostic claims or incorporating AI/algorithmic components.

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The MROpen is a total body magnetic resonance imaging device, It is indicated for use as a diagnostic total body imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The MROpen is a total body magnetic resonance imaging device

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria, device performance, study details, expert qualifications, adjudication methods, or the use of AI in a comparative effectiveness study.

The document is a 510(k) premarket notification letter from the FDA to Paramed Srl concerning their "MrOpen" Magnetic Resonance diagnostic device. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements.

Specifically, the text is a formal communication acknowledging the filing and approval of the 510(k) and provides the "Indications For Use" for the MrOpen device. It does not include any technical data, study results, or performance metrics that would be necessary to populate the table or answer the specific questions about acceptance criteria and how they were met.

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