(70 days)
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.
- To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.
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 FFR/iFR displayed value 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.
- . Import and display of image data from endoluminal modalities, leading to a joint display of images acquired by x-Ray and endoluminal imaging and corresponding to same selected luminal locations or segments (also known as co-registration of such modalities).
The provided text describes a 510(k) premarket notification for the SyncVision System, focusing on software and labeling changes, and an expansion of the Indications For Use. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it mentions "Applicable testing was performed as required by the Quality System to evaluate the modifications to the SyncVision System software." The reported performance is a qualitative statement: "The test results were found to be acceptable by the respective test plans and protocols."
Therefore, based on the provided text, a table of quantitative acceptance criteria and specific device performance metrics cannot be constructed.
2. Sample Size Used for the Test Set and the Data Provenance
The document states "Applicable testing was performed...Software Verification and Validation" and "Simulated Use Validation." However, it does not provide any details regarding the:
- Sample size used for these tests.
- Data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide any information about experts, ground truth establishment, or their qualifications for the test set.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
The document does not provide any information about an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device's function is described as automating a manual workflow process (co-registration of angiographic x-ray and IVUS/FFR/iFR images/values). It facilitates clinical decision making by presenting aligned information, rather than directly acting as an AI diagnostic aid that human readers would "improve with."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The document describes the SyncVision System as an "image acquisition and processing system" that automates a co-registration process. While the system performs functions like "automatic presents an image frame" and "automates the manual registration processes," it is designed to be used "in-procedure in the catheterization lab" by an "interventional cardiologist." This implies a human-in-the-loop scenario. The text does not explicitly state if a standalone algorithm-only performance study was conducted.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for any testing.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This is a 510(k) submission primarily focusing on software and labeling changes for an existing device, and it does not detail the development or training of new AI models.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned (see point 8), the document naturally does not provide any information on how its ground truth was established.
Summary of available information regarding acceptance criteria and study:
The provided text focuses on demonstrating substantial equivalence to a predicate device based on software verification and validation and simulated use validation tests. It confirms that "test results were found to be acceptable by the respective test plans and protocols," but does not offer specific quantitative acceptance criteria or detailed performance metrics. Furthermore, it lacks information on sample sizes, data provenance, expert involvement, adjudication methods, or the specifics of any comparative effectiveness or standalone studies. The nature of the device, which automates an image co-registration workflow for interventional cardiologists, suggests a human-in-the-loop design rather than a fully autonomous AI diagnostic tool requiring extensive standalone performance evaluation in the context of this submission.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.