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Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

The AIRIS Elite Body Coil (hereby referred to as body coil) is a receive only RF phased array coil, used for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system. The body coil consists two mechanical sections: a rigid removable upper section and a base, which is positioned above and below the patient abdomen respectively. The upper section can be connected to the base by the electrical pins. There is a latch on the upper section. The coil consists of four coil elements: a two-turn solenoid, an anterior saddle, a posterior saddle and an anti-turn loop. All the elements are enclosed in a rigid plastic housing. The signal output of each element is independently processed by the system to enhance performance.

The provided text does not contain information about acceptance criteria, a study that proves the device meets specific criteria, or performance data in the format requested. The document is a 510(k) summary for a medical device (AIRIS Elite Rapid Body Coil) that outlines its intended use, function, scientific concepts, and concludes that it is substantially equivalent to a predicate device.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define any specific acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio thresholds) or provide performance metrics from a study that evaluates the device against such criteria.
• Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data (country, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications: No test set means no ground truth establishment for it is discussed.
• Adjudication method for the test set: Not applicable as no test set is mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no mention of an MRMC study or any impact of AI assistance on human readers.
• Standalone (algorithm only) performance: This device is a hardware component (a coil for an MRI system), not an algorithm, so standalone algorithm performance is not applicable.
• Type of ground truth used: No ground truth is discussed in relation to performance evaluation.
• Sample size for the training set: Not applicable, as this is a hardware device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar technological characteristics and intended use. It describes the physical and performance characteristics of the body coil in a general sense, noting it's a "receive only RF phased array coil" and how it functions within the MRI system, but it does not present a formal study with acceptance criteria and measured performance outcomes. The "performance characteristics" mentioned are descriptive of the device's design (e.g., four channel vs. two in predicate) rather than quantitative results from a performance study.

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Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

Model 554HI-12 RAPID Body Coil. Compatible with Hitachi AIRIS-Elite MR Systems.

The provided document is a 510(k) Summary of Safety and Effectiveness for the "Model 554HI-12 RAPID Body Coil." This document is part of a premarket notification for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report for a novel AI/software device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, cannot be found in this document because it pertains to the regulatory review process for a hardware component (an MRI coil) based on substantial equivalence, not a software or AI device's clinical performance study.

However, I can extract the information that is present and explain why other details are absent based on the nature of this document.

Here's a breakdown of the available and unavailable information:

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

The document defines acceptance criteria by stating that the new device has "No change" in specific safety and imaging performance parameters compared to the predicate device. This implies that "no change" is the acceptance criterion for equivalence.

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

• Sample Size for Test Set: Not applicable/not provided. This document describes a new MRI coil seeking clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study with a "test set" in the context of an AI/software device. The "testing" would involve demonstrating the new coil functions within the safety and performance limits when paired with a compatible MRI system, and that these parameters are equivalent to those of the predicate.
• Data Provenance: Not applicable/not provided.

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)

• Number of Experts: Not applicable/not provided.
• Qualifications of Experts: Not applicable/not provided.

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

• Adjudication Method: Not applicable/not provided.

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

• MRMC Study: No, this type of study was not performed. The device is an MRI body coil, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not applicable. The device is a hardware component (an MRI coil), not a standalone algorithm.

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

• Type of Ground Truth: Not applicable in the context of a clinical performance study with "ground truth" as typically defined for AI/software. The "ground truth" for this device's assessment would be established engineering and safety standards for MRI coils and comparison to the predicate device's established performance specifications. The "ground truth" for the claims of "no change" would be derived from technical measurements and comparisons.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth for Training Set Establishment: Not applicable. This is not an AI/machine learning device.

Summary of Device and Regulatory Context for Understanding:

This document is a 510(k) submission for an MRI coil, which is a hardware accessory for an MRI system. The primary goal of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has:

• The same intended use as the predicate device.
• The same technological characteristics as the predicate device, or
• Different technological characteristics that do not raise new questions of safety and effectiveness, and performance data that demonstrates the device is as safe and effective as the predicate device.

In this specific case, the manufacturer is demonstrating that its Model 554HI-12 RAPID Body Coil, when used with the Hitachi AIRIS-Elite 0.3T MRI system, is substantially equivalent to a GE Signa 0.5T system operated with a legally marketed predicate device. The "study" described is a comparison of critical safety and imaging performance parameters, where the finding that there is "no change" in these parameters due to the new coil is the basis for demonstrating equivalence and meeting regulatory requirements. It is not a clinical performance study measuring diagnostic accuracy or reader improvement for a software algorithm.

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