(207 days)
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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Image /page/0/Picture/0 description: The image shows a circular logo with a stylized design. The logo appears to be a dark color, possibly black, against a lighter background. The design within the circle is intricate and abstract, with curved lines and shapes that create a sense of movement and complexity.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '5', '4', '3', '5', and '4'. The digits are written in a cursive style, with some of them connected to each other. The overall appearance suggests that the sequence was written quickly and informally.
GE Medical Systems
Commit Electric Company
O Box 414, Milwaukee, WT 53201
APR 1 2 1996
0.2T GP Neck/Shoulder Coil
September 14, 1995
General Electric Medical Systems
SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
- Contact: Larry A. Kroger Phone: 414-544-3894 414-544-3863 Fax:
- 0.2T GP Neck/Shoulder Coll Product: Manufactured by GE Yokogawa Medical System, Ltd. Tokyo, Japan
1) Indications for Use
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.
2) Device Description
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.
3) Marketing History
The 0.2T GP Neck/Shoulder Coil has not been previously marketed by GE Medical Systems.
4) Potential Adverse Effects on Health
The use of the 0.2T GP Neck/Shoulder Coil does not result in any additional potential hazards compared to previously marketed receive-only surface coils.
5) Conclusions
It is the opinion of GE Medical Systems that the 0.2T GP Neck/Shoulder Coil is substantially equivalent to the presently marketed GE Shoulder Surface Coll (#K892235).
§ 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.