(148 days)
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.
-
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) -
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).
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
§ 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.