(28 days)
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.
The 8 Channel Cardiac Phased Array Coil is a modification to the 8 Channel Cardiac Phased Array Coil (K022669), which features a flexible anterior half of the coil.
The provided text is a 510(k) summary for a medical device, specifically an 8 Channel Cardiac Phased Array Coil. It details the device's modification from a predicate device and states that testing was performed to demonstrate that the design modifications meet predetermined acceptance criteria. However, the document does not explicitly state what those acceptance criteria are, nor does it provide details of the study that proves the device meets them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
Based on the provided text, the following information can be extracted:
- Device Name: 8 Channel Cardiac Phased Array Coil
- Purpose of the study: To demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria.
- Conclusion: GE states that the modified device is substantially equivalent to the predicate device (K022669) and does not result in any new potential hazards.
Missing Information:
All of the following information is not available in the provided document:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
- If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on regulatory approval based on demonstrating substantial equivalence, rather than a detailed scientific study report with specific performance metrics and validation methodologies.
§ 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.