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The MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).

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 (T1), 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 MrJ 3300 is a magnetic resonance imaging device characterized by an open structure to minize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.

It is indicated for use as a diagnostic imaging device that produces transverse, sagittal. coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot; shoulder, elbow, wrist; hand, calf, thigh, arm, forearm. Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography). ....

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 vield information that can be useful in the determination of a diagnosis. ... .

The MrJ 3300 has a 0,3 T magnet, which has a higher intensity than the predicate one (0,2T). Of course the new 0,3 T magnet with slightly different dimensions needs a new design of covers and some modest upgrades due to design ageing of the MrJ Inspire 01-2000-01 product.

New covers of the system have been designed by the same company which designed MRJ Inspire's covers and they have been manufactured using the same C-UL-US approved fire protection materials.

The MrJ 3300 employs both the positioning LED (K033507) and the positioning touch screen . (K100164) to give to the user the maximum chances to get rapidly to the correct patient of positioning.

The scanning sequences are the same employed in MrJ Inspire model (K100164) unless the FLAIR sequences which are equivalent to the same FLAIR sequences employed on the MrOpen 05 T K101295 device.

The MrJ 3300 is furnished with the Performance Package of new concept receiving coils . (code 06-0096-00) equivalent to the Performance Package K121249.

The Paramd MrJ 3300 is a magnetic resonance imaging device.

1. Acceptance Criteria and Reported Device Performance:

   The submission does not explicitly state "acceptance criteria" for clinical performance. Instead, it aims to demonstrate substantial equivalence to predicate devices, implying that if the device performs equivalently in a clinical setting, it meets the inherent acceptance criteria of a diagnostic MRI system whose predicates are already on the market. The study attempts to show that the MrJ 3300's generated images are "clinically acceptable" and equivalent to those from the predicate devices.

   Parameter	Acceptance Criteria (Implied)	Reported Device Performance
   Image Quality	Clinically acceptable, equivalent to predicate devices	"Proposed images... are clinically acceptable as those presented for the same districts in previous 510(k) files to which equivalence is claimed."
   Coils	Coils must be equivalent to those on predicate devices	All coils listed (Knee, Hip, Hand, Shoulder, TMJ, etc.) are "Equivalent" to corresponding coils on MrJ Inspire K100164.
   Sequences	Sequences must be equivalent to those on predicate devices	All sequences listed (SCOUT, SE, E-RASE, DE, GFE, STIR, etc.) are "Equivalent" to corresponding sequences on MrJ Inspire K100164 or MrOpen 0.5T K101295.
   Safety/Effectiveness	As safe and effective as predicate devices	"MrJ 3300 device is at least as safe and effective as the predicate devices." (based on non-clinical and clinical-like observations)

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

   The document mentions "test images performed both on phantoms and on healthy volunteers" for the "clinical tests." However, it does not specify the sample size for these healthy volunteers, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth:

   The submission states that images should be "interpreted by a trained physician" or a "medical expert." It does not specify the number of experts used to establish ground truth for the test set, nor does it provide their specific qualifications (e.g., years of experience). The assessment of "clinical acceptability" appears to be an internal conclusion rather than an independent expert review with quantified metrics.

4. Adjudication Method for the Test Set:

   No specific adjudication method (e.g., 2+1, 3+1) is mentioned or described for the assessment of the clinical images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study design described does not involve human readers comparing performance with and without AI assistance or between this device and other devices. It focuses on demonstrating equivalency of image quality for diagnostic interpretation.

6. Standalone Performance Study:

   Yes, a type of standalone (algorithm only) performance assessment was implicitly done for the device in terms of image quality. The claim is that the images produced by the MrJ 3300 are "clinically acceptable" on their own for diagnostic interpretation by a medical expert, equivalent to those from existing devices. The document does not describe a human-in-the-loop experiment designed to improve human reader performance using the device.

7. Type of Ground Truth Used:

   The ground truth for the "clinical tests" appears to be based on the general "clinical acceptability" of the images as interpreted by medical experts, implying a form of expert consensus on diagnostic utility. No specific pathology, outcomes data, or definitive diagnostic truth is explicitly mentioned as being used to validate the images.

8. Sample Size for the Training Set:

   The document does not mention a training set for an algorithm. This submission describes an MRI device itself, not an AI or algorithm that would require a distinct training set. The "clinical tests" refer to assessing the diagnostic imaging capabilities of the hardware and software for image generation.

9. How Ground Truth for the Training Set Was Established:

   As there is no mention of an algorithm requiring a training set, the question of how ground truth was established for a training set is not applicable here.

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The intended use of the Performance package is to enable the permanent magnet based MRI systems designed by Paramed (MrJ and MrJ Inspire) to perform MR scan of the following districts: C-Spine one dedicated coil (code 01-2023), L-Spine two sizes of dedicated coils (codes 01-2021 and 01-2022), all other joints using a linear single channel coil named MP wrap (code 01-2024) which is not aimed to specific districts but can fit most joints (such as, for instance, knee, foot, ankle, elbow, wrist, hand ... ). The Performance package inherits the same limitations of the System to which it is applied which is: only joint pathologies ( no tumor, no angiography). The Performance package enables the MRI System to which it is applied to acquire images of the districts being diagnosed in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The Performance Package for MrJ series (MrJ and MRJ Inpsire) permanent magnet based MRI tomographs is a set of receiving coils intended to increase patient comfort while performing the same district examinations already performed by previously marketed receiving coils. The two here proposed Kits differ only for what regards the connector to the magnet which for MrJ is flat and for MrJ Inspire it is round. The components of the Performance Package (for MrJ and MRJ Inpsire) are the following: C-Spine dedicated coil, L-Spine dedicated coils (Small size and Large size), MP_wrap multipurpose coil. The Proposed coils are receive coils. The images produced by the device, when Performance Package is employed 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 (T1), 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.

Acceptance Criteria and Device Performance Study for Paramed Performance Package

This document describes the acceptance criteria and the study conducted to demonstrate that the Paramed Performance Package accessory for MRI systems meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are focused on the Signal-to-Noise (S/N) ratio, measured according to NEMA procedures.

*Note: The values accepted at final inspection are derived from those obtained according to NEMA procedure with scaling factors applied to take into account different sequence and FOV. The reported device performance (Signal/Noise as measured through NEMA Standard) meets or exceeds the specified acceptance criteria for all listed coils.

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

The document indicates "test images performed both on phantoms and on healthy volunteers." However, specific sample sizes for the test set (number of phantoms and healthy volunteers) are not provided in the submitted summary.

The provenance of the data is implied to be from internal laboratory testing conducted by Paramed S.r.l. in Genova, Italy. The testing included both phantom studies and studies with healthy volunteers, suggesting a prospective data collection approach for at least the volunteer component.

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

The document states that if images are "interpreted by a medical expert, these images can provide diagnostically useful information." However, the number of experts used to establish the ground truth for the test set and their specific qualifications are not explicitly stated within the provided text. The phrase "medical expert" is general and does not provide specific details on their background (e.g., radiologists, years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth from multiple experts. Given that the study primarily focuses on technical performance like SNR and general image quality assessment, formal expert adjudication of diagnostic outcomes may not have been deemed necessary or explicitly documented for this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided special 510(k) summary. The document does not discuss the effect size of how much human readers improve with AI vs. without AI assistance, as AI assistance is not the subject of this submission. The device is a set of receiving coils, an accessory for MRI systems, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone (algorithm only) performance study was conducted or is applicable to this device. The Performance Package consists of MRI receiving coils, which are hardware accessories, not algorithms or software that operate independently without human interaction.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through:

• Phantom studies: These evaluate objective technical parameters like Signal-to-Noise Ratio (SNR) under controlled conditions.
• Healthy volunteer images: These allow for the assessment of image quality in human subjects, likely evaluated subjectively by experts or internally against established standards for clear anatomical visualization.

The document emphasizes that clinical output is "documented at section Validation activities" and that "no clinical study is necessary" because the components are "well known in the clinical practice." This implies that the 'ground truth' for image diagnostic utility relies on the well-established principles of MRI and the visual interpretability of the acquired images rather than specific disease outcomes or pathology.

8. Sample Size for the Training Set

No sample size for a training set is provided. The device is a physical accessory (MRI coils), not a machine learning or AI algorithm that requires a training set.

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

This question is not applicable as there is no training set for this device.

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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 intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ Inspire device can also produce images of the C-Spine and L-Spine joinls. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The Mr Inspire is a magnetic resonance imaging device characterized by an open structure to minimize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.

The provided text is a 510(k) summary for the Paramed Mr Inspire MRI system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, much of the requested information cannot be extracted directly from this document because the regulatory pathway for this device is based on substantial equivalence to existing devices, not on proving explicit performance against pre-defined clinical acceptance criteria like those expected for novel diagnostic algorithms.

Here's a breakdown of what can be inferred or is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting pathologies) for the Mr Inspire. Instead, it compares technical parameters to its predicate device, the MrJ. The implicit acceptance criterion is that the technical parameters and image quality are equivalent or better than the predicate device.

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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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The intended use of Paramed's MRJ_Extended product is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, call, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C- spine and L-Spine with limitation to joint pathologies (no tumors, no anglography). The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation fime (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The MRJ Extended MRI system is substantially equivalent to the currently available Paramed MrJ cleared via K033507 for all items excluded the spine coils for which the and Esaote S-Scan system cleared via K063207 is addressed.

The provided text is a 510(k) summary for the MRJ_Extended Magnetic Resonance Diagnostic Device. It states that the device is substantially equivalent to legally marketed predicate devices (Paramed MrJ K033507 and Esaote S-Scan K063207).

However, the document does not contain information regarding:

• Specific acceptance criteria metrics (e.g., sensitivity, specificity, accuracy targets).
• Any formal study designed to demonstrate device performance against such criteria.
• Data provenance, sample sizes for test sets, or training sets.
• The number or qualifications of experts used for ground truth establishment or adjudication methods.
• Whether MRMC or standalone performance studies were conducted.
• The type of ground truth used.

The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria and results. The "study" mentioned refers implicitly to the comparison with predicate devices, which is the basis of a 510(k) submission, but it doesn't provide the type of detailed performance study sought by this request.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The included text is a regulatory submission for device clearance, not a performance study report.

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The intended use of Paramed's MRJ product is for diagnostic MRI imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, TMJ and cervical spine with limitation to joint pathologies -- no tumors, no angiography. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend on the MR parameters (spin-lattice relaxation time -- T1, spin-spin relaxation time -- T2, nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MRJ) and does not contain the detailed information about acceptance criteria or specific study results as requested in your prompt. The document primarily focuses on regulatory approval and indications for use, without delving into the specifics of performance metrics, sample sizes, or ground truth establishment.

To answer your questions, I would need a different type of document, such as a clinical study report, a technical performance report, or the 510(k) submission summary that details the studies conducted.

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