(77 days)
Synapse 3D Cerebral Analysis is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cerebral Analysis accepts DICOM compliant medical images acquired from CT. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse 3D Basic Tools, Synapse 3D Cerebral Analysis provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (TTP).
Synapse 3D Cerebral Analysis is medical imaging software used with Synapse 3D Basic Tools. It provides tools to aid in reading, interpreting, reporting, and treatment planning. It accepts DICOM compliant medical images acquired from CT. It provides parameter images by post-processing with dynamic scanned CT cerebral arteriography images to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (TTP).
This device is a medical image processing and analysis software called Synapse 3D Cerebral Analysis. The provided text is a 510(k) summary and FDA clearance letter, which means it describes the device and its intended use but does not contain a detailed study report with specific acceptance criteria and performance metrics typically found in a clinical or validation study section.
Therefore, the requested information cannot be fully extracted from the given text. The document focuses on regulatory clearance by demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria.
However, based on the available information, here's what can be gathered, with significant gaps due to the nature of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given regulatory submission. The document states the device "provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images to aid the assessment of cerebral blood flow" and lists the parameters (CBV, CBF, MTT, TTP), but it does not specify acceptance criteria for the accuracy or performance of these generated parameter images, nor does it report any associated device performance metrics against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given regulatory submission. The document does not describe any specific test set used for performance evaluation that would include sample size or data provenance details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given regulatory submission. The document does not describe the establishment of a ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the given regulatory submission. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
This information is not provided in the given regulatory submission. There is no mention of an MRMC comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not explicitly stated or detailed in the given regulatory submission. While the device processes images to generate parameters, the document does not describe a standalone performance study with specific metrics, methodology, or results. The focus is on the device's function as a tool to aid professionals.
7. The Type of Ground Truth Used
This information is not provided in the given regulatory submission. No ground truth is described.
8. The Sample Size for the Training Set
This information is not provided in the given regulatory submission. The document does not mention a training set, as it describes a software application that performs post-processing of images, not a machine learning model that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as no training set or ground truth for a training set is mentioned in the document.
Summary of Device and Study (Based on Fragmentary Information):
The device, Synapse 3D Cerebral Analysis, is medical imaging software intended to assist trained medical imaging professionals (Physicians and Radiologists) in reading, interpreting, reporting, and treatment planning by post-processing dynamic scanned CT cerebral arteriography images. It generates parameter images for Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (TTP) to aid in the assessment of cerebral blood flow.
The provided text is a regulatory submission for 510(k) clearance, which confirms substantial equivalence to a predicate device. It does not contain the details of a specific clinical or validation study that would outline acceptance criteria, test set characteristics, expert qualifications, or detailed performance metrics. The clearance is based on the claim that the device, when used in conjunction with Synapse 3D Basic Tools, provides similar functionality to legally marketed predicate devices for image processing and analysis.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).