(28 days)
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.
§ 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.