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The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals, for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software.

The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest.

When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The images can be interpreted by medical professionals or facilitate Radiation Therapy (RT) planning.

The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths:

• AIR Open Head Neck Posterior 9ch
• AIR Open Neck Chest Anterior 7ch
• AIR Open Head Anterior 16ch .

The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MR Overlay for GE Motus, Kizuna, and GEM as well as the associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner)

The 1.5T 32Ch AIR Open Coil Suite and the 3.0T 32Ch AIR Open Coil Suite are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.

The 32Ch AIR Open Coil Suite is intended for use in a manner that is identical to the predicate device described in this submission.

Proposed labeling is documented in the Instructions for Use manual for the 32Ch AIR Open Coil Suite (NC139IFU-en).

The provided text describes the acceptance criteria and study proving a medical device, the 32Ch AIR Open Coil Suite, meets these criteria. However, it focuses primarily on bench testing (performance testing) and briefly mentions clinical performance testing without detailing the specifics typically found in studies designed to prove performance against specific clinical acceptance criteria (like diagnostic efficacy, AI algorithm performance, etc.).

The document outlines a 510(k) submission for an MRI RF Receive-Only Coil, which is an imaging accessory, not an AI-powered diagnostic device. Therefore, the common elements of acceptance criteria and study designs for AI/CADe systems (such as sensitivity, specificity, MRMC studies, expert adjudication, ground truth establishment for a diagnostic output) are not directly applicable or present in this document.

The "study" described herein is a series of engineering and safety tests to demonstrate substantial equivalence to a predicate device, as required for a 510(k) clearance, concerning physical and electrical performance, biocompatibility, and image quality (SNR, uniformity). It does not involve an AI algorithm that produces a diagnostic output, nor does it describe a study like a clinical trial for diagnostic performance.

Given this, I will interpret your request keeping in mind the nature of the device and the provided document. I will focus on the acceptance criteria and performance data that are present, and explicitly state where information relevant to AI/CADe validation is not available or not applicable.

Here's an analysis based on the provided text:

Device Name: 32Ch AIR Open Coil Suite (comprising various 1.5T and 3.0T AIR Open Head Neck Posterior, Neck Chest Anterior, and Head Anterior coils).

Device Type: Magnetic Resonance Imaging (MRI) RF Receive-Only Coils. This is a hardware component for MRI systems, not a software-based AI diagnostic tool.

Purpose of Testing: To demonstrate that the device is safe and effective and performs in a manner that demonstrates substantial equivalence to the predicate device (3.0T GEM RT Open Array, K143389).

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a table outlining various bench tests (non-clinical performance testing). These tests are primarily focused on safety, electrical performance, and physical image quality characteristics of the MRI coils.

Note: The document also mentions "Clinical data exhibits a mix of technical factors and anatomy as recommended in FDA guidance; Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016." and "No adverse events were reported during clinical performance testing." However, detailed acceptance criteria for clinical performance (e.g., specific image quality metrics, diagnostic accuracy, etc., that would typically be seen for an AI diagnostic device) are not provided in this regulatory summary. The "clinical performance testing" seems to primarily refer to general image observation to ensure functionality, not a rigorous clinical trial for diagnostic performance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Clinical Data): The document states "Clinical data exhibits a mix of technical factors and anatomy as recommended in FDA guidance." However, specific sample sizes (number of patients/cases), country of origin, or whether the data was retrospective or prospective are not provided in this summary.
• Test Set (Bench Data): For bench testing, the "sample size" is inherently the number of physical coil units tested or the number of experiments performed. This detail is not quantified (e.g., "N=3 coils tested for each parameter").

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable in the context of AI/CADe ground truth: This device is an MRI coil, not a diagnostic AI algorithm that requires expert-established ground truth for diagnostic outputs.
• The "clinical performance testing" would likely involve medical professionals (e.g., radiologists) interpreting images for general quality and usability, but the document does not specify the number or qualifications of experts involved in the "clinical data" review. The stated objective for the device is "to produce diagnostic images of the head, neck, and brachial plexus structures. The interpreted by medical professionals or facilitate Radiation Therapy RT planning." This implies human interpretation.

4. Adjudication Method for the Test Set

• Not applicable in the context of AI/CADe ground truth adjudication: Since this is not an AI diagnostic device, formal adjudication methods for ground truth (like 2+1 or 3+1 consensus) are not described or relevant for the types of tests reported.
• For the "clinical performance testing," the method of image assessment (e.g., unanimous agreement on usability/quality by a panel) is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done, nor is it applicable: This type of study (comparing human readers with and without AI assistance for diagnostic performance, or comparing different AI algorithms) is specifically for evaluating the effectiveness of AI-powered diagnostic tools or CADe systems. The 32Ch AIR Open Coil Suite is an MRI hardware component.

6. Standalone Performance (Algorithm Only)

• Not applicable: This is an MRI coil, a hardware component. There is no "algorithm only" performance to evaluate. The device's performance is intrinsically linked to its use with an MRI scanner and subsequent human interpretation of the images it helps acquire.

7. Type of Ground Truth Used

• Not applicable in the context of AI/CADe diagnostic ground truth.
• For the performance testing that was conducted:
  • Bench Tests: The "ground truth" for these tests is defined by established engineering and safety standards (e.g., IEC standards, NEMA MS 6-2008). The criteria are objective measurements against these standards (e.g., temperature limits, signal-to-noise ratio, image uniformity).
  • Clinical Performance: The "ground truth" for assessing image quality and usability in a clinical context would be the subjective and objective assessment by trained medical professionals (e.g., radiologists) determining if the images are diagnostically acceptable and if the coil is usable. No specific details are provided.

8. Sample Size for the Training Set

• Not applicable: This device does not involve a machine learning or AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable: As there is no AI algorithm and no training set, the establishment of ground truth for a training set is irrelevant for this device.

Summary:

The provided document details a regulatory submission (510(k)) that focuses on demonstrating the substantial equivalence of new MRI coils to a previously cleared predicate device. The "acceptance criteria" and "proof" provided are primarily related to general device safety, electrical performance, and basic image quality metrics as measured by engineering tests. While clinical data is mentioned, it appears to be for general observational assessment of usability and image quality rather than for quantifying diagnostic performance outcomes, which would be the case for an AI-powered diagnostic device. Therefore, many of the questions asked, particularly those pertaining to AI/CADe validation (MRMC studies, expert ground truth establishment, training sets), are not applicable to the nature of the device and the testing described in this document.

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