(35 days)
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation toollo (vessel centerline calculation, lumen calculation, stenosis calculation) 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 lesinos in blood vessels and evaluation, documentation and follow-up of any such lesion. These visualization/processing/evaluation tools allow for characterization of vascular 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 tissus.
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) 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 lesions in blood vessels and evaluation, documentation and follow-up follow-up of of any such lesion. These visualization/processing/evaluation tools allow for characterization of vascular 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 text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or detailed results of device performance metrics like sensitivity, specificity, or accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional comparison and adherence to standards.
The document indicates that "Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence." This implies that internal acceptance criteria were met during development, but those specific criteria and their corresponding results are not disclosed in this 510(k) summary.
Therefore, a table cannot be populated with specific acceptance criteria and reported numerical performance values from this document.
However, based on the narrative, the device performance is implicitly claimed to be "as well as the predicate devices" due to "equivalent technological characteristics" and "current image processing algorithms."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Non clinical tests are conducted for syngo.CT Vascular Analysis software package during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards."
- Sample Size for Test Set: Not specified.
- Data Provenance: The document only mentions "Non clinical tests" during product development. It does not provide information on the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for the specific "non clinical tests" mentioned.
4. Adjudication Method for the Test Set
The document does not provide any information regarding the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
The document does not report an MRMC comparative effectiveness study involving human readers and AI assistance. The focus is on the device's standalone functionalities and its equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone evaluation was done. The "non clinical tests" and the claim of functional equivalence to predicate devices which are also image analysis software, imply that the algorithm's performance was assessed independently. The purpose of syngo.CT Vascular Analysis is to provide "visualization/processing/evaluation tools" and "reporting tools" to support the physician, rather than to replace them or directly interact in a real-time assistive manner during interpretation, as might be evaluated in an MRMC study. The device's capabilities are described as tools for lumen/stenosis calculation, bone removal, vessel tracking, etc., which are functions of the algorithm itself.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the non-clinical tests. Given the nature of the software (image processing and measurement), it's likely that ground truth would involve either:
- Reference measurements from gold-standard techniques (if available for specific features like stenosis).
- Expert consensus measurements.
- Pathology (less likely for general vascular analysis measurements, more for specific findings).
- Outcomes data (unlikely for non-clinical testing for this type of software).
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only mentions "non clinical tests" conducted during product development, which typically follow a training/testing paradigm but the details are not provided.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the 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.