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The MRI diagnostic Device is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images display the internal structure of the body regions for which it is indicated (shoulder, elbow, hand, wrist, foot, ankle, knee, hip, calf, thigh, arm, forearm, Temporo Mandibular Joint, 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 (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 Upgrade Kit MR GUI PRO is a kit containing HW and SW to upgrade previously cleared installed models (K033507, K100164, K122034) to the state of the art. MrJ 3300 Plus is the commercial name of the same Upgrade Kit when integrated in factory on newly manufactured K122034+this change. The modification introduces an internally developed User Interface 0 and upgrades computer/spectrometer hardware to the state of the art to run user interface 0. The produced images will still 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.

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML powered device performance. The document describes an "Upgrade Kit MR GUI PRO" (and "MrJ 3300 Plus") for an MRI diagnostic device, primarily focusing on hardware and software updates to previously cleared MRI devices.

It explicitly states:

• "No clinical tests were performed."
• The "non clinical (ACR Test) data demonstrate Upgrade Kit MR GUI PRO to be as safe, as effective and performs as well than the predicates."

The "ACR Test" refers to tests performed using an American College of Radiology (ACR) phantom to verify proper functioning of the MRI system and its image quality, not a study evaluating clinical performance or a specific feature against acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them as if it were an AI/ML powered device. The questions in the prompt are geared towards AI/ML device evaluations, which are not applicable to the content of this 510(k) summary.

Instead, I will summarize what the document does state about "performance data" as requested in 807.92(b):

(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on:
The submission relies on the fact that all proposed modified hardware was already cleared within a previous 510(k) (K190524), meaning no safety tests (related to hardware) were repeated.
For software, conformance was granted towards IEC 62304 standard (Software lifecycle) and NEMA PS 3.1 (DICOM conformance). These standards were met, and software changes were tested as part of K190524.
Additionally, images from ACR tests (American College of Radiology phantom tests) were performed in-firm to check the proper functioning of the software. Various standard MR sequences (e.g., FSE T2, FSE T1, FIR PD, GE T1, Stir GE, Spin Echo, 3D GBASS, 3D GFE T1) were acquired using an ACR phantom.

(2) A brief discussion of the clinical tests submitted, referenced, or relied on:
"No clinical tests were performed."

(3) The conclusions drawn from the nonclinical and clinical tests:
"The non clinical (ACR Test) data demonstrate Upgrade Kit MR GUI PRO to be as safe, as effective and performs as well than the predicates." The device is considered substantially equivalent to legally marketed devices and conforms to applicable medical device safety and performance standards.

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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 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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