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Intended Use: The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system. The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for Use: The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen.

The Picker Phased Array Flexible Cardiac Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil.

The provided text describes a 510(k) premarket notification for the "Phased Array Flexible Cardiac Coil," seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating equivalence rather than establishing new acceptance criteria and conducting a study to prove they are met in the same way a de novo or PMA submission would.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific effect sizes, and how training ground truth was established) are not applicable to this 510(k) submission as these types of detailed studies are not typically required for a substantial equivalence determination based on device components and intended use.

Here's an analysis based on the provided information, focusing on what is available:

Acceptance Criteria and Device Performance Study for the Phased Array Flexible Cardiac Coil

This submission is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device rather than setting new, specific performance acceptance criteria and then proving the device meets them through a dedicated primary effectiveness study. The "acceptance criteria" here are implicitly satisfied by demonstrating equivalence to the predicate device across key parameters.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k), 'acceptance criteria' are primarily alignment with the predicate device's specifications and performance where direct comparison is relevant. Since no specific performance metrics like sensitivity, specificity, or accuracy are provided, the table below focuses on the comparative parameters used to demonstrate substantial equivalence to the predicate device (Picker Phased Array Flexible Body Coil, K962117).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This 510(k) submission does not describe a clinical study with a test set in the traditional sense for evaluating device performance against pre-defined metrics. Substantial equivalence is demonstrated through comparison of technical characteristics and intended use to an already cleared device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No explicit ground truth establishment or expert review for a test set is documented in this 510(k) summary. The comparison is based on technical specifications and intended use.

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

• Not Applicable. No test set or adjudication method is described.

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 is a hardware component (MRI coil), not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not Applicable. This is a hardware component (MRI coil), not a software algorithm.

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

• Not Applicable. No clinical ground truth is established for this submission. The "ground truth" for substantial equivalence is the technical specifications and intended use of the legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. This is a hardware component; there is no "training set" in the context of machine learning or algorithm development.

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

• Not Applicable. As there is no training set, this is not applicable.

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