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The SyncVision System is an image acquisition and processing system. It is indicated for use as follows;

• · To provide quantitative information regarding the calculated dimensions of arterial segments.
• · To enhance visualization of the stent deployment region.
• · To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
• · To obtain a co-registration of an angiographic x-ray image and IVUS images.

The SyncVision System is an image acquisition and processing workstation situated in the coronary catheterization lab and intended to be used during coronary catheterizations. The SyncVision System captures angiographic and intravascular ultrasound (IVUS) image streams and performs the following display functions for assisting the interventional cardiologist:

• . During Lesion Evaluation; angiogram and IVUS image selection, quantitative coronary measurements (lesion diameters, length, % stenosis), vessel region enhancement and vessel region stabilization are performed instantly and online.
• . During Device Positioning, Deployment and Post-deployment; an on-line image stream derived from the native angiographic image stream that is enhanced and stabilized, is displayed side-by-side to the native angiographic and IVUS image streams.
• . Display of native image / data streams used before or during trans-catheter cardiovascular interventions, leading to a joint display of images corresponding to the same selected vascular locations or segments (also known as co-registration).

The System are comprised of a workstation, and LCD monitor, keyboard, mouse and an isolation transformer installed in the control room of the catheterization lab, as well as a user input device (joystick) installed in the procedure room. The workstation is comprised of a PC equipped with an internal high-resolution dual channel frame grabber, a high-performance graphic processing card and a data acquisition card for ECG signal acquisition. The joystick allows the user to control all of the functions of the System from the procedure room. Cables connect the workstation to data sources which are an input device; the joystick previously mentions, the x-ray imaging system, IVUS imaging system, and the ECG monitor. Cables also connect the workstation to an existing output monitor (not supplied with the System) situated in the procedure room and provide the user in the procedure room with the visual output of the System side-by-side to the existing displays.

The provided document does not contain detailed acceptance criteria and a study proving the device meets those criteria. It is a 510(k) summary for the SyncVision System, primarily focusing on software and labeling changes from a predicate device.

However, based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document states "The test results were found to be acceptable by the respective test plans and protocols," but does not detail the specific acceptance criteria or the quantitative performance results.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided. The document mentions "Simulated Use Validation" but does not specify the sample size, country of origin, or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided.

4. Adjudication Method:

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided. The document describes the system as automating a "currently manual workflow process used by interventional cardiologists today" for co-registration, implying a potential for such a study, but no details are given.

6. Standalone (Algorithm Only) Performance Study:

The document mentions "Software Verification and Validation" and "Simulated Use Validation." These likely include testing of the algorithm's performance, but a dedicated "standalone" study with specific metrics and results is not explicitly detailed. The device description emphasizes the co-registration feature and quantitative measurements, which are algorithm-driven, implying standalone performance was evaluated.

7. Type of Ground Truth Used:

This information is not explicitly stated. Given the device's functions (quantitative measurements, co-registration of angiographic x-ray and IVUS images), the ground truth for these features would likely involve:

• Expert consensus: For validating the accuracy of co-registration and visual enhancements.
• Manual measurements by experts: For validating the quantitative information regarding arterial segment dimensions.
• Potentially anatomical phantoms or highly detailed imaging: For objective validation of measurements and co-registration.

8. Sample Size for the Training Set:

This information is not provided. The document describes software changes and validation but does not discuss machine learning model training or associated datasets.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided, as details about a training set are absent.

In summary, the provided FDA 510(k) summary focuses on the substantial equivalence of the modified SyncVision System to a predicate device, primarily due to software and labeling changes. It confirms that necessary verification and validation testing was performed and found acceptable, but it does not disclose the specific acceptance criteria, detailed study designs, sample sizes, or performance metrics that would answer the questions posed.

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