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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:
  • GE Medical Systems 1.5T Cardiac Phased Array (K971667)
  • USA Instruments Torso and Pelvis Phased Array Coil (K001209)
• 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.

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