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The NeoCoil 3.0T 32-Channel Torso Array Coil is a receive only phased array RF coil used to produce diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging systems that can be interpreted by a trained physician. The NeoCoil 3.0T 32-Channel Torso Array Coil is designed for use with the 3.0T HD Series MR System manufactured by General Electric Healthcare (GEHC).

The NeoCoil 3.0T 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.0T GE HD series Magnetic Resonance scanners.

The NeoCoil 3.0T 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE 3.0T HD Series MR System (K052293)

This 510(k) summary for the NeoCoil 3.0T 32-Channel Torso Array Coil does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for AI/ML or diagnostic devices.

The document describes a magnetic resonance specialty coil, which is a hardware component used in MR imaging systems. It is not an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, the requested information cannot be extracted for this specific submission because it's not relevant to the type of device being reviewed.

However, I can describe what type of information is present, which relates to validating hardware performance, rather than AI algorithm performance.

Here's a breakdown of what is and isn't available based on your request and the provided text:

1. A table of acceptance criteria and the reported device performance

• Not applicable for AI/ML metrics. The document states: "Testing was performed to demonstrate that the design of the NeoCoil 3.0T Summary of Studies: 32-Channel Torso Array Coil met predetermined acceptance criteria." However, it does not explicitly list the acceptance criteria or the specific results of these tests. For a medical device like an MRI coil, acceptance criteria would typically involve engineering specifications related to safety (e.g., heating, electromagnetic compatibility), image quality (e.g., signal-to-noise ratio, uniformity), and compatibility with the MR system.

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 device is a hardware component. Its performance is evaluated through engineering tests, not on a dataset of patient images.

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. There is no "ground truth" in the diagnostic sense for a hardware coil. The "interpretation by a trained physician" mentioned in the Intended Use refers to the subsequent use of images produced by the coil, not a validation of the coil itself.

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

• Not applicable.

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 device, not an AI algorithm.

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

• Not applicable. This is a hardware device.

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

• Not applicable.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable.

Summary of what is present:

The submission focuses on demonstrating substantial equivalence to predicate devices (GE 3.0T Torso Phased Array Coil and GE 1.5T 8 Channel Torso Coil) based on:

• Device description: Multi-element phased array receive-only coil with 34 elements (17 anterior, 17 posterior) for 3.0T GE HD Series MR Systems.
• Intended Use/Indications for Use: To produce diagnostic images of chest, abdomen, and pelvic areas for 2D and 3D MRI and parallel body imaging.
• Performance Testing (implied): "Testing was performed to demonstrate that the design of the NeoCoil 3.0T 32-Channel Torso Array Coil met predetermined acceptance criteria." This implies engineering and performance tests relevant to MR coils (e.g., electrical characteristics, image quality parameters, safety aspects like SAR, specific absorption rate), but the details are not provided in this summary.
• Safety: "Use of the NeoCoil 3.0T 32-Channel Torso Array Coil does not result in any new potential hazards and does not alter the safety of the MRI scanner."

In conclusion, for this specific 510(k) for an MRI coil, the requested AI/ML specific criteria (ground truth, sample sizes, reader studies) are not applicable as the device is not an AI/ML diagnostic software. The "acceptance criteria" likely refer to technical performance and safety specifications for the hardware.

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