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The Endorectal Coil is indicated for use as diagnostic device extension for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, displaying the internal structure of the prostate.

These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The Endorectal Coil (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946, 3.0T Endorectal Coil O-HLE-030-01900 and ER Coil Support ZUB-01955) is designed for use with a magnetic resonance (MR) system. The coil is designed to work in unison with the Body Coil (BC) of the MR system, which will excite the hydrogen (1H) nuclei with radio frequency (RF) magnetic fields, so that the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as a reusable receive-only coil for high resolution MR examination of the prostate.

The coil housing is minimum sized and drop-shaped for better patient comfort. It features a flat top to minimize the distance of the inside receive coil electronics to the prostate. The coil is receive-only (Rx) and consists of a single loop coil element with an integrated low noise preamplifier and a connector to the GE 1.5 T MR-System or GE 3.0 T MR-System. The coil is fixed tuned and matched to the typical loading condition of a prostate examination at the Larmor frequency of 1H at 1.5 T (63.9 MHz) or 3.0 T (127.7 MHz), respectively. Decoupling circuits are integrated in the single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse.

It is recommended to employ an Endorectal Coil Model in combination with the additional available ER Coil Support. The ER Coil Support is designed for use with any Endorectal Coil Model (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946 and 3.0T Endorectal Coil O-HLE-030-01900). It supports stabilizing the Endorectal Coil in any position required by each individual endorectal MR examination. The ER Coil Support features a collet for acceptance of the Endorectal Coil. The Endorectal Coil is fixated inside the collet by tightening of a knurled screw. It offers five degrees of freedom to align the position of the collet with the required spatial position of the Endorectal Coil housing. Two additional knurled screws allow the lock the ER Coil Support in the desired alignment.

The provided document is a 510(k) summary for MRI Endorectal Coils (1.5T and 3.0T) and an ER Coil Support. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study report demonstrating the device meets those criteria for clinical AI/ML-based diagnostic devices.

The information sought in your request (acceptance criteria, specific study details with sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance, training set details) is typically found in detailed clinical validation reports for AI/ML diagnostic tools. The submitted document for the Endorectal Coil, being a device accessory used to produce images, focuses on performance metrics like Signal-to-Noise Ratio (SNR) and Image Uniformity, safety standards compliance, and clinical image quality in vivo. It does not describe a study involving an AI algorithm making diagnoses or clinical decisions based on these images.

Therefore, many of the specific questions you've asked about AI/ML device validation cannot be answered from this document. However, I can extract information related to the device's technical performance and the nature of the "tests" conducted to support its substantial equivalence.

Here's an attempt to answer based on the available information, noting the limitations due to the nature of the device and the document:

Acceptance Criteria and Study for RAPID Biomedical Endorectal Coils

This submission pertains to an MRI accessory (endorectal coil), not an AI/ML diagnostic device that provides interpretations or diagnoses. Therefore, the "acceptance criteria" and "study" described are focused on the coil's technical performance, fundamental safety, and generation of adequate image quality for human interpretation, rather than the diagnostic accuracy of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Nonclinical Tests (Phantom): No specific number provided for the "sample size" of phantoms or tests conducted. It involved "a phantom" (singular).
• Clinical Tests (In Vivo): No specific number of patients or images provided. The document states "Clinical tests were performed in order to check image quality in vivo." and "Sample clinical images in DICOM format are provided as part of the discussion of the clinical tests submitted." This implies a limited, likely small, number of cases for qualitative assessment.
• Data Provenance: Not explicitly stated, but given the manufacturer (RAPID Biomedical GmbH) is in Germany, and the device is for GE MR Systems, the testing likely occurred in a European or US setting, possibly at GE's facilities or collaborating sites. Retrospective/Prospective is not specified, but in vivo testing would inherently involve prospective patient imaging or use of existing image datasets.

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

This is not applicable in the context of this submission. The device is a hardware accessory (an endorectal coil) that produces images; it does not generate a diagnostic output requiring comparison to an expert-established ground truth for performance evaluation in the way an AI diagnostic algorithm would. The "interpretation by a trained physician" is mentioned in the Indications for Use, implying that human experts are the ones making diagnoses from the images produced by the coil, but their role in establishing "ground truth" for the coil's performance itself is not described.

4. Adjudication method for the test set:

Not applicable. There is no diagnostic output from the device itself to adjudicate.

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

No. MRMC studies are typically performed for diagnostic devices (especially AI/ML software) to evaluate the impact of the device on human reader performance. This submission is for an MRI coil, which is hardware for image acquisition.

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

Not applicable. The device is hardware. It is explicitly stated that the images it produces are "when interpreted by a trained physician, yield information that may assist in diagnosis." This indicates a human-in-the-loop workflow for diagnosis, as the device itself is not making a diagnosis.

7. The type of ground truth used:

• Nonclinical (Phantom): The "ground truth" for technical performance (SNR, Image Uniformity) is comparison against established engineering standards (NEMA) and the performance of the predicate device, using objective measurements on a phantom.
• Clinical (In Vivo): The "ground truth" for adequacy of image quality in vivo is likely a qualitative assessment by experienced personnel/physicians as to whether the images show sufficient detail, contrast, and lack of artifacts for diagnostic purposes. This is not "ground truth" in the sense of a confirmed clinical diagnosis (e.g., pathology report) but rather an evaluation of the image's technical and clinical usability.

8. The sample size for the training set:

Not applicable. This is an MRI coil (hardware), not an AI/ML algorithm that requires a "training set."

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

Not applicable. (See #8)

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