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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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