(51 days)
Accessory for axial compression of the Lumbar spine in CT and MR Indication For Use. "Accessory for was vempresses during research and clinical purposes.
Through compression of the spine with a Harness, two cords and a foot part improve CT and MR diagnostic of the spinal canal.
I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or details about any studies conducted (e.g., standalone, MRMC) for the DynaWell device.
The document is a 510(k) summary, which primarily focuses on establishing substantial equivalence to a predicate device. It provides:
- Device Description: What the DynaWell is and how it functions (compression of the spine for improved CT/MR diagnostics).
- Intended Use: Criteria for when to use the device (e.g., neurogenic claudication, suspected dural sac deformation) and contraindications (e.g., vertebral trauma, osteoporosis).
- Regulatory Information: FDA's 510(k) clearance letter and the "Indication For Use" statement.
To answer your request, I would need a document that specifically details the performance evaluation, clinical studies, and acceptance criteria for the DynaWell device.
§ 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.