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The Medrad Flex Interface Device(FID) provides the interface, connection, and support functions to permit the use of Medrad Disposable Endorectal Prostate, Cervix, and Colon Coils, with the Siemens Medical Systems Vision 1.5 Tesla and Impact 1.0 Tesla MRI Scanner Systems.

The Medrad Flex Interface Device and the the Medrad Disposable Endorectal Prostate(BPX), Cervix(BCR), and Colon(PCC) Coils are intended for high resolution Magnetic Resonance Imaging of the human prostate, cervix, colon, and the surrounding pelvic anatomy.

The Medrad Magnetic Resonance Endorectal Coil Imaging System consists of a disposable, receive only probe for MR Imaging of the associated anatomy. The Medrad Interface Device provides the interface, decoupling, and support functions required to successfully operate the probe with the Siemens Medical Systems Vision & Impact MRI Scanner Systems. The hardware is intended for repeated use with suitable Medrad disposable MRI probes. The Interface Device provides the tuning and impedance matching of the disposable probe to the Siemens Flex Coil Interface optionally used with the Siemens Vision & Impact MRI Systems.

This document is a 510(k) summary for the Medrad Flex Interface Device, which is a connecting device for MRI systems. The provided text does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or image quality.

Instead, the documentation focuses on the device's description, intended use, and its substantial equivalence to a predicate device (Medrad Probe Interface Device - K926571) as required for regulatory approval. The "acceptance criteria" here are implicitly related to the device successfully providing the specified interface and connection functions, and regulatory compliance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the information that is available:

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

Regarding the Study:

The document does not describe a clinical performance study with specific metrics (like sensitivity, specificity, accuracy) that would typically be associated with AI or diagnostic imaging devices. Instead, the "study" demonstrating that the device meets criteria is the demonstration of substantial equivalence to a predicate device for its engineering and functional aspects. This typically involves engineering verification and validation, but not a large-scale clinical trial with performance metrics.

Therefore, the following information is NOT available in the provided text:

• 2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 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: This is an interface device, not an AI or diagnostic tool that would involve human readers interpreting results. Therefore, an MRMC study is not relevant and not discussed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a device of this nature. The "ground truth" would be the successful physical and electrical connection and functionality.
• 8. The sample size for the training set: Not applicable, as this is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

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