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The Signa SP Flexible Coll family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.

The Signa SP Flex Colls are a group of symmetric transmit/receive surface colls of varying dimensions that are coupled as helmholtz pairs and contained in a flexible, biocompatible outer covering.

I am sorry, but the provided text is a 510(k) summary for a medical device (Signa SP Flex Coils) from 1997. It describes the device, its intended use, and its substantial equivalence to a predicate device.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information from the given input. The information you are asking for typically comes from a detailed clinical study report, which is not present here.

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The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accomodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures.

The 0.2T GP Neck/Shoulder Coil is a receive-only, linear, circular solencidal coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and comfort pads for support.

The provided document is a 510(k) summary for a medical device: a 0.2T GP Neck/Shoulder Coil. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study demonstrating the device's performance against specific acceptance criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what's missing:

• No Acceptance Criteria or Performance Study: The document is a regulatory submission (510(k) summary) aiming to show that the new device is "substantially equivalent" to an already approved device (GE Shoulder Surface Coil #K892235). It does not describe performance thresholds (acceptance criteria) that the device must meet to be considered effective or safe, nor does it detail a study designed to measure the device's performance against such criteria.
• Focus on Equivalence, Not De Novo Performance: The marketing history states, "The 0.2T GP Neck/Shoulder Coil has not been previously marketed by GE Medical Systems," and the conclusion states it is "substantially equivalent to the presently marketed GE Shoulder Surface Coll." This indicates the approval pathway is based on comparing the new device's characteristics (design, materials, indications for use, safety) to an existing, approved device, not on independent, de novo performance validation.
• Device Type: This is a receive-only coil for an MRI system. Its "performance" would typically be evaluated in terms of signal-to-noise ratio, field of view, image uniformity, and artifact reduction when used with an MRI system. These types of quantitative performance metrics and the studies to assess them are not detailed here.

To answer your prompt, I would need a different type of document that describes a study evaluating the performance of a medical device (often for a novel device or a device claiming specific performance metrics beyond equivalence). Such a document would typically include:

• Performance Metrics: Specific, measurable outcomes (e.g., sensitivity, specificity, accuracy for diagnostic devices; signal-to-noise ratio for imaging coils).
• Acceptance Criteria: Predetermined thresholds for these performance metrics that the device must achieve.
• Study Design: Details of a clinical or technical study, including sample size, data collection methods, ground truth establishment, reader involvement, etc.

Since this information is absent from the provided 510(k) summary, I cannot generate the requested table and details.

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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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