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The 0.2T Extremity Coil expands the capability of the 0.2T MR imaging system. lt accommodates and improves imaging of the knee and surrounding structures. It can also be used to image other extremity body parts such as the ankle and wrist.

The 0.2T Extremity coil is a quadrature receive-only coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and patient comfort pads for support. It is designed specifically for use with a vertical magnetic field MR imaging system.

This document, a 510(k) summary for the GE 0.2T Extremity Coil, does not describe the acceptance criteria and a study proving the device meets those criteria in the way requested. It is a pre-market notification document for a medical device (a coil for an MRI system), focusing on demonstrating substantial equivalence to a previously marketed device rather than presenting performance metrics and validation studies.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The 0.2T Extremity Coil is a hardware component for an MRI system, not an algorithm or a diagnostic tool that produces quantitative outputs like accuracy, sensitivity, or specificity. Therefore, performance metrics typically associated with AI/software devices (like those in your request) are not applicable or presented here.
• Regulatory Pathway: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device, often by comparing design, materials, indications for use, and performance characteristics. It does not typically require extensive clinical trials or performance studies with detailed statistical analyses for diagnostic accuracy.
• Content of the Document: The document focuses on:
  • Indications for Use
  • Device Description
  • Marketing History
  • Potential Adverse Effects (stating none additional compared to predicate)
  • Conclusion of Substantial Equivalence

Therefore, I cannot provide the requested table or answer most of the specific questions.

If this were a document about a diagnostic AI/software device, the information would typically include:

1. Table of Acceptance Criteria and Reported Device Performance: This would list metrics like sensitivity, specificity, accuracy, AUC, F1-score, and predetermined thresholds for each to be considered "accepted."
2. Sample Size and Data Provenance: Details about the number of cases (e.g., images, patient records) in the test set, where they came from (e.g., specific hospitals, countries), and whether they were collected retrospectively or prospectively.
3. Number and Qualifications of Experts: Information on how many clinicians (e.g., radiologists, pathologists) reviewed the test cases to establish ground truth, along with their specialties and experience levels.
4. Adjudication Method: How disagreements among experts were resolved (e.g., majority vote, senior expert arbitration).
5. MRMC Comparative Effectiveness Study: Whether human performance was compared with and without AI assistance, and the magnitude of any observed improvement (effect size).
6. Standalone Performance: The performance of the algorithm without human intervention.
7. Type of Ground Truth: The definitive source of truth used for evaluation (e.g., pathology reports, follow-up outcomes, surgical findings, expert consensus).
8. Training Set Sample Size: The number of cases used to train the AI model.
9. Training Set Ground Truth Establishment: How the ground truth for the training data was determined.

This 510(k) summary for the 0.2T Extremity Coil does not contain any of this information because it's a different type of medical device and regulatory submission.

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