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The Promaxo Magnetic Resonance Imaging (MRI) System is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR guidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and a 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.

Promaxo's MRI system is an open configuration MRI system composed of an array of permanent magnets arranged to provide a constant in-plane magnetic field strength and a built-in z-gradient within its field of view. The system utilizes electromagnetic gradient coils, RF coils, and other components such as the spectrometer and signal amplifiers to capture, reconstruct and display magnetic resonance images of objects within its field of view. Promaxo MRI System's technological features are substantially equivalent to its predicate device. Both of them:

• Are comprised of a magnet, magnet enclosure, electromagnetic gradient coils, RF transmission coil, and RF receiver coil
• Have the main magnet comprised of an array of permanent magnets
• Measure spatial distribution of protons exhibiting magnetic resonance
• Are capable of imaging T1, T2, and Diffusion-Weighted Imaging
• Are cryogen free
• Provide an interactive user interface to operate the device -

Promaxo's MRI system differs in technology in the following ways:

• The z-gradient is built into the main magnetic field and, as a result, the system does not require an electromagnetic z-gradient coil
• The device includes a template holder to be used for procedures under MR guidance
• The device includes an MR guidance user interface workflow such as template calibration and registration with imported MR images

When analyzing the provided document (K202518 - Promaxo MRI System), it becomes clear that the FDA clearance is NOT for an AI/ML device. The document explicitly states:

• Promaxo MR images are not intended to be used for diagnostic purposes. (Page 2 & 4)
• A 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System. (Page 2 & 4)
• Promaxo MRI System is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR guidance in alignment with the current standard of care. (Page 2 & 4)
• Image Processing: None (Page 5, first table)

This device is an MRI system used for guidance/targeting of prostatic lesions based on previously acquired diagnostic 3T MRI images. It does not diagnose, interpret, or process images in a way that would involve AI/ML. The "Summary of Clinical Testing" section mentions "registration accuracy and motion studies using the Promaxo MRI System on clinical images of human subjects" and an "end-to-end clinical feasibility study", but these are related to the physical system's ability to guide procedures, not to an AI's performance in image analysis or diagnosis.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment for AI training/test sets) does not apply to this specific device. The document focuses on demonstrating substantial equivalence to a predicate MRI system based on hardware characteristics, safety standards, and performance in guidance tasks, not on diagnostic accuracy of an AI algorithm.

Consequently, I cannot provide the requested information as it pertains to an AI/ML device. The document does not contain data or studies related to the performance of an AI algorithm according to the criteria listed in your prompt.

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