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Probe: The DxTx e²Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e²Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e²Coil probe has been designed to be inserted into the human rectum. The e²Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e²Coil probe insertion.

Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e²Coil™) provides interface and support functions to allow the use of 3.0T disposable e²Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device.

The e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is a combination of the following two devices for improving the diagnostic MR image of the prostate and its surrounding pelvic tissues:

• Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect (e2Coil)
• Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2Coil) – Siemens
  • Coil contains two loops and four channels

The intended contact duration of the device is less than 60 minutes.

No components of this device contain medicinal substances, tissues or blood products.

The patient contacting device component materials are Latex, PVC, and Polymer.

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets those criteria for the e²Coil™ Imaging System.

Here's an breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test set (e.g., number of coils for mechanical testing, number of measurements for SNR). The nature of the device (an MRI coil) suggests that testing would involve a representative number of manufactured units rather than patient data.

The data provenance is internal testing performed by the manufacturer, DxTx Medical, Inc., for regulatory submission. There is no mention of external data or patient data provenance in this summarized document.

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

This information is not provided in the document. The studies performed (biocompatibility, electrical safety, mechanical, MR safety, SNR, uniformity) are primarily objective engineering and scientific tests based on established standards (e.g., ISO, IEC, NEMA), rather than interpretations by medical experts to establish a "ground truth" in the diagnostic sense.

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

This is not applicable to the types of performance tests conducted for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the focus of these engineering and safety tests.

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:

This is not applicable. The e²Coil™ Imaging System is an MRI coil, a hardware component, not an AI-powered diagnostic software. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant to this device.

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

This is not applicable, as the device is an MRI coil, not a standalone algorithm.

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

The "ground truth" for the performance characteristics measured in this submission is based on established engineering and scientific standards and physical properties. For example:

• Biocompatibility: Adherence to ISO 10993-1:2018 and FDA Guidance 635.
• Electrical Safety & EMC: Compliance with IEC 60601-1.
• Mechanical Testing: Compliance with IEC 60601-1.
• MR Safety: Compliance with IEC 60601-2-33.
• SNR & Uniformity: Adherence to NEMA MS 1 and NEMA MS 3/IEC 62464-1 standards.

These are objective, measurable criteria, not subjective interpretations requiring expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set:

Not applicable. This device is an MRI coil, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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