(14 days)
The coil is indicated for use, on the order of a physician in conjunction with a 3.0T MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.
The primary applications associated with evaluation of the anatomy are as follows:
- Thorax
- Abdomen
- Male and Female Pelvis
- Prostate
The 3.0T Torso Phased Array Coil is a four-channel phased array receive only MR coil used in conjunction with the GE 3.0T MR system.
I am sorry, but the provided text does not contain the detailed information needed to construct a table of acceptance criteria and reported device performance, nor does it describe a study with the specific elements requested (like sample sizes, ground truth establishment, or expert qualifications).
The document is a 510(k) summary for a medical device (3.0T Torso Phased Array Coil) and a subsequent FDA letter of substantial equivalence. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or a comprehensive list of acceptance criteria with measured performance metrics.
Here's what I can infer from the text, and where the requested information is missing:
Missing Information:
- Specific Acceptance Criteria: The document states "Testing was performed to demonstrate that the design of the 4 channel 3.0T Torso Phased Array Coil meet predetermined acceptance criteria," but it does not list what those criteria are or what quantitative or qualitative performance metrics were used.
- Reported Device Performance: Since the acceptance criteria are not specified, the document also does not report specific performance against these criteria.
- Sample Size for Test Set: Not mentioned.
- Data Provenance (Country, Retrospective/Prospective): Not mentioned.
- Number of Experts for Ground Truth & Qualifications: Not mentioned, as no specific ground truth establishment is detailed for a clinical study.
- Adjudication Method: Not mentioned.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as being performed. The document focuses on device characteristics and equivalence, not reader performance.
- Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device (MR coil), not an algorithm.
- Type of Ground Truth: Not explicitly stated for any testing, but implied to be related to image quality and system compatibility for an MR coil.
- Sample Size for Training Set: Not applicable/not mentioned, as there is no machine learning algorithm being "trained" in this context.
- How Ground Truth for Training Set was Established: Not applicable/not mentioned.
What the document does state (and why it doesn't fit your request format):
The document primarily describes:
- Device Name: 3.0T Torso Phased Array Coil
- Indicated Use: To produce images of the abdominal and pelvic regions in 2D and 3D with a 3.0T MR scanner, for applications like thorax, abdomen, male/female pelvis, and prostate imaging.
- Substantial Equivalence: The key contention is that this device is substantially equivalent to two predicate devices:
- Differences from Predicate: The main differences identified are:
- Tuning frequency (127.72MHz for 3.0T vs. 63.86MHz for 1.5T)
- Dimensions (34cm wide and 32cm long for 3.0T Torso vs. smaller for 1.5T Cardiac) for higher FOV coverage.
- Conclusion: The device meets predetermined acceptance criteria and does not result in new potential hazards, leading to the conclusion of substantial equivalence.
In summary, this document is a regulatory submission focused on demonstrating equivalence and safety, not a detailed clinical trial report or performance study with the metrics you've requested.
§ 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.