(82 days)
Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets.
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion.
These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets.
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a formal table or list quantifiable performance metrics with specific thresholds. Instead, it refers to general safety and effectiveness concerns and the device's intended use, which is to support physicians in confirming the presence or absence of coronary lesions, and evaluating and documenting them.
The document highlights the device's functionality and visualization tools, implying that these capabilities are what define its "performance." However, no numerical performance data (e.g., sensitivity, specificity, accuracy for lesion detection or quantification) is presented.
2. Sample Size for the Test Set and Data Provenance
The provided text does not include information about the sample size used for a test set, nor does it specify the data provenance (country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not include information about the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The provided text does not include information about any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The provided text does not explicitly describe a standalone (algorithm-only) performance study with quantifiable results. The description of the device focuses on its role as an "image analysis software package" designed to "support the physician," implying a human-in-the-loop workflow rather than a fully autonomous application.
7. Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used for any evaluation. Given the context of coronary analysis, likely ground truth would involve either invasive coronary angiography (ICA) or expert consensus readings by cardiologists/radiologists. However, this is not confirmed in the document.
8. Sample Size for the Training Set
The provided text does not include any information about the sample size used for a training set. The document is a 510(k) summary, which often focuses on substantial equivalence to predicate devices and general safety/effectiveness, rather than detailed algorithmic training and validation specifics.
9. How Ground Truth for the Training Set Was Established
The provided text does not describe how ground truth for any training set was established.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.