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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular, pulmonary, renal, and abdominal systems that can be interpreted by a trained physician.

Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils

This document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device, Invivo Corporation's Cardiovascular Array Coils, is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the provided text.

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The Cardiovascular Array is intended for multiple imaging applications with GE Sigua(R) 1.5T MRI Systems. Its large field of view will allow with GE Sigual(R) 1.51 MK. Systems. Including the heart, and its associated for images of the complete chords, and spine. A specialized sub-array vasculature, the abdomen, pervis and open and of the thoracic region, :

The Cardiovascular Array is a receive only phased array coll, + 2009 and a posterior "paddle." The phased array design includes 10 elements in a flexible coil, which array design mendatibody sizes. The coil produces high conforms to different GE Signa® 1.5T MRI Systems.

The provided text is a 510(k) Premarket Notification summary for the Cardiovascular Array, an MRI surface coil. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new medical device is safe and effective through comprehensive clinical trials with pre-defined acceptance criteria and study designs in the way that, for example, a new drug would be.

Therefore, many of the requested elements (e.g., specific acceptance criteria, detailed study design with sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included or required in a 510(k) summary focused on substantial equivalence. The focus is on comparing technical characteristics and intended use to an existing device.

Here's an analysis based on the provided text, addressing what can be inferred and explicitly stating what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission. Acceptance criteria and specific performance metrics for this device are not defined in the document as it's a submission for substantial equivalence to a predicate device. The performance is deemed "sufficient to demonstrate substantial equivalence" based on descriptive information and data, but no specific quantitative criteria are listed.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified.
• Data provenance: Not specified. The submission refers to "performance data," but details on the nature, origin (e.g., country), or whether it was retrospective or prospective are not provided in this summary. It's likely bench testing and potentially some phantom or volunteer imaging data, typical for device equivalence, rather than a large patient study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The concept of "ground truth" established by experts for a test set is typically relevant for studies evaluating diagnostic accuracy, often with an AI component. This 510(k) submission is for an MRI surface coil, a hardware component, where the assessment is primarily about its imaging capabilities (e.g., signal-to-noise ratio, image quality) and safety compared to a predicate device, not its diagnostic interpretation accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used to reach consensus on diagnostic labels, which is not the primary focus of a 510(k) for an MRI coil.

5. 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

Not applicable. This device is an MRI surface coil, not an AI or software algorithm that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an MRI surface coil, not an algorithm. Standalone performance as an algorithm is not relevant. The "standalone" performance for a coil would refer to its physical imaging characteristics, which are implicitly compared to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the typical sense. For an MRI coil, "ground truth" would relate to objective physical measurements of image quality parameters (e.g., SNR, uniformity, resolution) and safety (e.g., heating, SAR), compared against established engineering standards or the performance of the predicate device. It would not involve diagnostic ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. This device is a hardware component (MRI coil), not a software algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as a training set for an algorithm is not relevant for this device.

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