(17 days)
S-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 hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.
S-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.
The system is composed of these main parts:
- Patient positioning table.
- Magnetic unit with the display panel.
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
- Electronics box with filter panel.
The provided text is a 510(k) summary for the S-scan MRI system. It describes the device, its intended use, and technological characteristics compared to predicate devices. However, it does not contain information about acceptance criteria, specific performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance).
The document focuses on demonstrating substantial equivalence to existing MRI systems based on similar technology and intended use, rather than presenting a detailed performance evaluation with specific acceptance criteria as one might expect for a new diagnostic algorithm or AI-powered device.
Therefore, I cannot populate the requested tables and information based on the provided text. The document primarily highlights modifications to an existing G-scan MRI system (K042236) and its similarity to other predicate devices like the E-scan Opera (K060956) and Siemens Magnetom C! (K043030).
The "Comments" column in the "Technological Characteristics" table mentions that some S-scan features (like oversampling and gradient moment nulling) are already in place on other commercial scanners (e.g., MAGNETOM C! K043030). This suggests that the substantial equivalence argument relies on the established performance of similar technologies in predicate devices, rather than a new, independent performance study with defined acceptance criteria for the S-scan.
§ 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.