(184 days)
The general-purpose magnetic resonance imaging (MRI) system is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures. Imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, imaging the pelvis and imaging the head. Outcomes related to diagnosis Magnifico is a Magnetic Resonance (MR) system that produces cross-section images of the limbs, joints, spinal column, pelvis and head. MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at imaging bones). These images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.
Magnifico is a Magnetic Resonance (MR) system with two configurations: 1. Magnifico Open, "Whole body" configuration (all above listed, in intended use, anatomical regions) 2. Magnifico MSK, musculoskeletal configuration (all above listed anatomical regions, excluded head and pelvis) which produces images of the internal structures of the patient's limbs, joints and spinal column. The system comprises four main parts: - Patient Table - . Magnetic Unit, containing a permanent magnet - Console, comprising a PC, keyboard, mouse, monitor and operating table - Electronic box Magnifico has an open magnet that makes comfortable MRI exam for all patients, including claustrophobic patients, in particular children. Additionally, Magnifico comes with a transparent headcoil for enhanced patient comfort.
The provided text is a 510(k) summary for the Esaote Magnifico MRI system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document focuses on regulatory compliance, technological characteristics, and safety standards for the MRI system itself, rather than the performance of an AI/ML powered device.
Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria and study details for an AI/ML powered device. The document describes image quality being "of good diagnostic quality by the board-certified radiologist, Dr. Mark Awh," but this is a general statement about the MRI system's output and does not constitute a detailed study validating an AI/ML algorithm's performance against specific acceptance criteria.
The questions you've asked are typically relevant for AI/ML-driven diagnostic or prognostic devices that analyze medical images. The Magnifico, as described, is the imaging hardware.
If there were an AI/ML component for analysis within the Magnifico system, or integrated with it, that information is not detailed in this 510(k) summary.
In summary, the provided document does not contain the information required to answer your questions regarding acceptance criteria and the study that proves an AI/ML powered device meets those criteria.
§ 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.