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AutoAlign software is intended to provide an output registration matrix that may be utilized to align an MRI brain scan to a known and consistent 3-dimensional (3-D) atlas of the human brain. AutoAlign software will be marketed as a software device that can provide improvements to the manual processes of MRI brain image registration.

To be utilized for the registration of brain images for MRI.

The device (software) operates by comparing a subjects' brain MR localizer images to a preexisting atlas of the human brain. The software then calculates a set of coordinates that can be used to align subsequent MRI images to the atlas. The accuracy of the alignment is measured and then programmatically reported. AutoAlign is a software device that provides the following features:

• . Imports MRI brain images
• Calculates and then outputs an optimized 3-D registration matrix that permits . alignment of the brain, regardless of the actual physical position of the subject's head in the image. For instance, in the test alignment:
  • o in the sagittal image, the intra-hemispheric plane is at the center slice of the MRI volume so the anterior & posterior commeasures (ac-pc line) are visible on that slice.
  • in the axial image, the intra-hemispheric plane is parallel to the Y axis. o
  • in the coronal image, the intra-hemispheric plane is parallel to the Y axis. o
• It can provide consistent scan/rescan alignment between separate scanning ● sessions within boundaries established and documented in Product Labeling Instructions.
• This software can be utilized by a MRI scanner original equipment manufacturer ● (OEM) to improve the workflow and automation of MRI brain study acquisitions.
• AutoAlign does not alter or otherwise modify the initial MR localizer image in any way
• The AutoAlign system does not have any adverse affects on health. This tool ● operates as a stand-alone software device, receives the MR scout localizer as input and outputs an optional registration prescription. AutoAlign does not alter or otherwise modify the initial MR localizer image in any way, and Labeling stipulates a review of the output registration by a trained MR operator.

The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets such criteria. It outlines the intended use, device description, and acknowledges that "Final Verification and Validation of the software has not been completed" and will be notified to the FDA upon completion. It mentions "Performance Testing: AutoAlign will successfully complete testing as detailed in the Clinical Performance Summary," but this summary is not provided in the excerpt.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth details.

The document is an Abbreviated 510(k) Summary and a subsequent FDA clearance letter. It serves to explain the device's purpose and its substantial equivalence to predicate devices, rather than providing a detailed clinical performance study report.

Key information from the document related to performance (but not meeting your request for detailed study results):

• Intended Use: "AutoAlign software is intended to provide an output registration matrix that may be utilized to align an MRI brain scan to a known and consistent 3-dimensional (3-D) atlas of the human brain. AutoAlign software will be marketed as a software device that can provide improvements to the manual processes of MRI brain image registration."
• Device Description (related to performance): "The accuracy of the alignment is measured and then programmatically reported." And, "It can provide consistent scan/rescan alignment between separate scanning sessions within boundaries established and documented in Product Labeling Instructions."
• Performance Testing: "AutoAlign will successfully complete testing as detailed in the Clinical Performance Summary." (This summary is missing).
• Regulatory Status: The FDA's clearance letter indicates the device is cleared for marketing based on substantial equivalence, with the expectation that verification and validation will be completed.

Without the "Clinical Performance Summary" or similar documentation, it's impossible to provide the requested details about acceptance criteria and the study that proves the device meets them.

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