(14 days)
For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician
The 1.5T Wrist Array Coil is a six channel phased array receive only coil. The coil has a rigid enclosure which is fire-rated and has impact and tensile strength. The mechanical housing is designed to follow the natural contours of the hand and wrist anatomy. The clamshell design allows the coil to open for patient positioning and alignment without electrical connections between the halves. The mechanical package also includes an adapter plate which can be used to help position patients.
This document is a 510(k) summary for a "1.5T Wrist Array Coil," a magnetic resonance (MR) specialty coil. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.
The provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
Here's why:
- Type of Device: This is a hardware component (a coil for an MRI machine), not a software algorithm, diagnostic AI, or an imaging modality requiring performance metrics like sensitivity, specificity, or reader studies.
- 510(k) Process: For a device like an MRI coil, the 510(k) process primarily focuses on:
- Substantial Equivalence: Comparing its design, materials, and intended use with existing, legally marketed predicate devices.
- Safety: Ensuring it doesn't introduce new safety hazards (e.g., electrical safety, mechanical safety, biocompatibility of materials if in patient contact).
- Performance: Demonstrating that it functions as expected (e.g., image quality, signal-to-noise ratio) and is compatible with the specified MRI scanner. However, this is usually documented through engineering tests and technical specifications, not clinical performance studies with acceptance criteria in the way you might see for an AI algorithm.
- Missing Information: The document focuses on the device description, its intended use, comparison to predicate devices, and the FDA's decision letter of substantial equivalence. There is no mention of a clinical study, reader study, AI algorithm, or specific performance metrics with acceptance thresholds.
Therefore, I cannot populate the requested table or answer the study-related questions because the provided text does not contain that information.
If this were an AI/diagnostic software device, the type of information you're asking for would be crucial and typically found in the clinical performance section of the 510(k) submission. However, for a hardware component like this MRI coil, the demonstration of safety and effectiveness relies on engineering specifications and demonstrable equivalence to predicate devices, rather than a clinical performance study with acceptance criteria as envisioned in your prompt.
§ 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.