(47 days)
G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for 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 imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections.
G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
G-scan is an open MRI system designed specifically to image limbs, joints and the spinal column.
The system is equipped with a hydraulic mechanism that will rotate both the magnet and the patient table from horizontal to vertical position, as shown in the following figures.
The patient may be scanned while lying down in a horizontal position and later he can be scanned vertically, in the weight bearing state, limited to the ankle, knee, hip and shoulder joint, and the spine.
The system is composed of these main parts:
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- Magnetic unit.
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- Electronics box.
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- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
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- Receiving coils.
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- Modular shielding box with filter panel.
The provided text is a 510(k) summary for the Esaote G-scan MRI system. It describes the device, its intended use, and its technological characteristics in comparison to predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for performance claims of a new medical device.
The 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices, primarily by comparing technical specifications. It highlights similarities and differences between the G-scan and predicate devices (E-scan XQ, AIRIS II, MAGNA SL, Magna 5000 Phased Array CTL Spine Coil, UROLOGIC table). The "Comments" sections in the tables explicitly state "Unchanged," "similar," or describe differences in technical parameters, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot extract the requested information based on the provided document. The document presents a technical comparison for substantial equivalence, not a performance study with defined acceptance criteria and results.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This document provides technical specifications and comparisons to predicate devices, but no explicit acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity) and no corresponding reported performance from a clinical study.
- Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
- Adjudication method for the test set: Not applicable as no performance study is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device described is an MRI system, not an AI-powered diagnostic tool, and no human-in-the-loop study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a traditional MRI system, not an algorithm.
- The type of ground truth used: Not applicable as no performance study is described.
- The sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.