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It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging

The Cardlac Phased Array Coil is a receive only coil with two separate coils matched with a front and a back (anterior and posterior) section.

Here's an analysis of the provided documents regarding the GE Medical Systems Cardiac Phased Array Coil, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document K971667 is a 510(k) summary for a medical device cleared in 1997. It is important to note that the level of detail regarding performance studies and acceptance criteria in 510(k) summaries from that era is significantly less comprehensive than what is typically expected for modern AI/ML device submissions. Therefore, many of the specific details requested in your prompt (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications for AI studies, MRMC studies, standalone performance) are not present in this document, as they are not applicable to the type of device (a medical coil) or the regulatory standards of that time.

Acceptance Criteria and Reported Device Performance

The Cardiac Phased Array Coil is a receive-only coil intended for use in MRI of the heart and mediastinum. Its substantial equivalence to predicate devices is based on similar construction, circuitry, and adherence to established performance standards for such equipment.

Details on the Study Proving Device Meets Acceptance Criteria

Given that this is a 510(k) summary for an MRI coil from 1997, the "study" referred to is primarily the testing against established engineering and safety standards, and a comparative analysis against predicate devices. It is not a clinical trial or performance study in the sense of evaluating an AI algorithm's diagnostic accuracy.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. For an MRI coil, "testing" would involve physical and electrical measurements of the coil's performance. The specific number of coils tested or the "sample size" of signal acquisitions performed during testing are not detailed but would be standard engineering validation activities.
   • Data Provenance: Not applicable in the context of AI/ML. The device itself is hardware. Testing would be performed in a controlled laboratory or clinical environment. Information on country of origin or retrospective/prospective nature is not provided, and not relevant for this type of device.

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

   • Not applicable. Ground truth, in the context of AI, refers to medically confirmed diagnoses or annotations. For an MRI coil, "ground truth" would relate to accurate physical measurements and adherence to engineering specifications, typically established by engineers and technicians.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic image interpretation studies. This is not relevant for an MRI coil.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC study is designed to assess the impact of a new diagnostic tool (often software or an AI algorithm) on human reader performance. This device is an MRI coil, a hardware component, not a diagnostic software tool that assists human readers.

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

   • No. This question is also highly relevant for AI algorithms. The Cardiac Phased Array Coil does not have "standalone" performance in the AI sense, as it is a component of an MRI system. Its performance is measured by its electrical characteristics and image quality contribution when integrated into the MRI system.

6. The type of ground truth used:

   • For this device, "ground truth" would refer to engineering specifications, electrical measurement standards, and safety standards. For example, the "ground truth" for SNR would be a defined measurement protocol and a target value based on NEMA MS#6. The "ground truth" for electrical safety would be adherence to the limits set by IEC 601-1. This is not pathology, outcomes data, or expert consensus in the diagnostic sense.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of AI/ML.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this hardware device.

Summary Specific to K971667:

The provided document indicates that the GE Medical Systems Cardiac Phased Array Coil was evaluated against the NEMA performance standard MS#6 for Special Purpose Coils and the IEC 601-1 International medical equipment safety standard. The "study" consisted of these evaluations and a comparison to predicate devices (ScanMed Cardiac/Vascular Coil and GE Pelvic Phased Array Coil) to establish substantial equivalence. The document explicitly states: "The Coil is comparable to the predicate devices." No clinical performance data, AI algorithm evaluations, or specific numerical performance metrics are provided in this summary, as these were not typically required or relevant for MRI coil 510(k) submissions in 1997. The acceptance criteria were met by demonstrating adherence to these established hardware performance and safety standards, and by showing equivalence to already marketed devices.

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