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The 3.0T 16 Channel Brain-Spine (NV) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar spine in Magnetic Resonance Imaging Systems. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.

The 3.0T Brain / Spine Array Coil is designed for use with the Excite 3.0T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.

The 3.0T 16 Channel Brain Spine () Array Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

The provided text describes a 510(k) premarket notification for a medical device, specifically a "3.0T 16 Channel Brain-Spine Array Coil". However, it does not explicitly detail the acceptance criteria or a comprehensive study report that proves the device meets specific performance criteria.

The document states: "Testing was performed to demonstrate that the design modifications to the 3.0T Brain / Spine Array meet predetermined acceptance criteria." but does not provide the criteria themselves or the results of the testing beyond a general statement of "substantial equivalence".

Therefore, I cannot provide the requested information for the following sections based on the input:

• A table of acceptance criteria and the reported device performance: The document mentions "predetermined acceptance criteria" but does not list them or report specific performance metrics against them.
• Sample sized used for the test set and the data provenance: No information is provided about the sample size or data origin for any testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: No details on adjudication are provided.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This study type is not mentioned or implied.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a hardware device (MRI coil) and not an AI algorithm, this type of study is not applicable and not mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is described.
• The sample size for the training set: Not applicable for this type of device and study.
• How the ground truth for the training set was established: Not applicable for this type of device and study.

Key takeaway from the provided text:

The document focuses on substantiating the claim of "substantial equivalence" to a predicate device (USA Instruments 3.0T 8 Channel Neurovascular Array coil, K032618) rather than detailing a specific performance study with explicit acceptance criteria. The modifications primarily involve increasing receive channels and integration for improved workflow and patient coverage, which are likely validated through technical engineering tests for signal quality, safety, and compatibility, rather than clinical efficacy studies with ground truth establishment in the traditional sense of diagnostic algorithms. The FDA review also confirms substantial equivalence, allowing the device to be marketed.

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