Search Results
Found 2 results
510(k) Data Aggregation
(89 days)
AUTOALIGN
AutoAlign™ Atlas-Based Image Registration software is intended to provide an output registration matrix that may be utilized to align an MRI brain scan to a known and consistent anatomic orientation, a process known as image registration. AutoAlign™ Atlas-Based Image Registration software is intended to be marketed as a software device that can provide improvements to the manual processes of image registration. The dominant use of AutoAlign™ Atlas-Based Image Registration software is its integration into proprietary MR image software packages by MRI scanner manufacturers to allow users to generate consistent patient image registrations for image acquisition, a process otherwise known as AutoSlice Prescriptioning.
AutoAlign™ Atlas-Based Image Registration software is intended to provide an output registration matrix that may be utilized to align an MRI brain scan to a known and consistent anatomic orientation, a process known as image registration. AutoAlign™ Atlas-Based Image Registration software is intended to be marketed as a software device that can provide improvements to the manual processes of image registration. The dominant use of AutoAlign™ Atlas-Based Image Registration software is its integration into proprietary MR image software packages by MRI scanner manufacturers to allow users to generate consistent patient image registrations for image acquisition, a process otherwise known as AutoSlice Prescriptioning.
AutoAlign™ Atlas-Based Image Registration has a feedback mechanism which measures and reports alignments which have the potential to be outside of stated specifications. This is reflected in as a "Measurement Index" value which is the average of the Mahalanobis distance for the voxel intensity of all atlas points to the patient images supplied for alignment.
The provided document describes the validation of the AutoAlign™ Atlas-Based Image Registration software. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Intended Use Claims) | Reported Device Performance (Mean ± Standard Deviation) |
|---|---|
| a) Inter-subject variability of AC: ≤ 15 mm | Mean distance between individual AC and reference: 3.90 mm (± 3.38 mm) |
| b) Inter-subject variability of PC: ≤ 13 mm | Mean distance between individual PC and reference: 2.69 mm (± 1.34 mm) |
| c) Inter-subject variability of IHP (sagittal views): ≤ 6 mm | Mean position of the IHP: -0.285 mm (standard deviation not explicitly stated for this metric in relation to the 6mm criterion, but IHP position is part of the overall dispersion calculation) |
| d) Inter-subject variability of angle formed by IHP and anterior-posterior line (axial views): ≤ 5 degrees | Mean angle (beta): 0.789 degrees (± 1.13 degrees) |
| e) Inter-subject variability of angle formed by IHP and superior-inferior line (coronal views): ≤ 7 degrees | Mean angle (gamma): -0.465 degrees (± 0.717 degrees) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 259 MR image volumes.
- Data Provenance: Retrospective, anonymous, low-resolution multispectral MR scans from actual adult subjects (ages 15-89) with both normal and abnormal pathologies, supplied by Siemens AG, Erlangen, Germany.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: One expert.
- Qualifications: Ph.D. trained in neurosciences.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method involving multiple experts for the ground truth. Instead, it states that "Post alignment measurements were made by an expert" (Ph.D. trained in neurosciences). Thus, the ground truth was established by a single expert.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the standalone performance of the algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The "Effectiveness" section describes testing the AutoAlign software's ability to align MR Neuro images. The measurements were made post-alignment by a single expert, indicating an evaluation of the algorithm's output. The "Measurement Index" serves as a safety mechanism for operator review but is not part of the core performance validation against the specified criteria, which are purely algorithmic accuracy metrics.
7. The Type of Ground Truth Used
The ground truth used was expert consensus (from a single expert) on anatomical landmarks and angles. The expert made measurements on the aligned images to determine the positions of the anterior commissure (AC), posterior commissure (PC), and inter-hemispheric plane (IHP), as well as specific angles.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for the training set. It mentions the "embedded reference neuroanatomic Atlas" but does not detail its creation or the data used to train the AutoAlign algorithm. The 259 cases were used to "validate and test the efficacy" of the software, implying they were a test set, not a training set.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set (i.e., the "embedded reference neuroanatomic Atlas") was established.
Ask a specific question about this device
(88 days)
AUTOALIGN
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.
Ask a specific question about this device
Page 1 of 1