(55 days)
MRI array coil for human extremities imaging Anatomical region: Anatomies in human extremities that have cross sectional diameter no larger than 4 "
High Temperature Superconducting (HTS) array coil
The provided document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information regarding detailed acceptance criteria, a study proving the device meets these criteria, or specific performance metrics.
Therefore, I cannot extract the requested information as it is not present in the provided text. The letter primarily states that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to proceed to market. It does not delve into the technical study details typically associated with acceptance criteria and performance validation.
Here's why the specific points cannot be addressed based on this document:
- Table of acceptance criteria and reported device performance: This document does not list any acceptance criteria or device performance data.
- Sample size, data provenance: No information on any studies, test sets, or data origin is present.
- Number of experts, qualifications: The document is a regulatory clearance and does not discuss human expert involvement in evaluating the device's performance.
- Adjudication method: Not applicable as no study details are provided.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone performance study: No details of any performance study (standalone or otherwise) are given.
- Type of ground truth: Not applicable as no study details are provided.
- Sample size for training set: Not applicable as no details of any training set or algorithm are provided.
- How ground truth for 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.