(56 days)
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 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.
§ 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.