(38 days)
The Sync Vision 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 (System) is displayed on a monitor that is situated next to the native xray, IVUS and FFR/iFR imaging and displayed value streams either in the cath lab or in the control room. The System provides a means to view the angiographic, IVUS, and FFR/IFR values on a single display and automates the manual registration processes performed by the physician. The objective of the SyncVision System is to optimize and facilitate trans-catheter cardiovascular interventions by means of automated on-line image processing. The current focus of the SyncVision System is on trans-catheter diagnostic and therapeutic interventions performed on the heart and the blood vessels directly connected to it. The SyncVision System's core component is an image acquisition and processing workstation situated in the coronary catheterization control room. The System also includes additional components such as a procedure room joystick, control room monitor, keyboard and mouse, medical grade isolation transformer along with site-specific cables and video equipment. 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 SyncVision System intends to capture the fluoroscopic image stream on line and perform the following functions for the purpose of assisting the interventional cardiologist in visualizing and quantitating the information resulting from images produced by the existing imaging modalities: During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and stenosis percentage), vessel region enhancement and vessel region stabilization are performed instantly and on line. During device positioning, deployment and post-deployment: An on-line image stream, that is enhanced and stabilized, is displayed side-by-side with the existing fluoroscopic image stream. Import and display of IVUS images, leading to a joint display of images acquired by X-Ray and IVUS images corresponding to same selected luminal locations or segments (also known as IVUS Co-registration). Import and display of Physiological values, leading to a joint display of images acquired by X-Ray and Physiological values corresponding to same selected luminal locations or segments (also known as Physiological Co-registration).
The provided document, a 510(k) premarket notification for the Volcano Corporation's SyncVision System (K172574), is for software modifications to an already cleared device (K161756). Therefore, the study described focuses on software verification and validation, rather than a de novo clinical study with human readers or standalone performance.
Here's a breakdown of the acceptance criteria and the study conducted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes software verification and validation, with "passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." Specific quantitative acceptance criteria or detailed results are not provided in this summary. Instead, the document summarizes the types of tests performed and the ultimate finding of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification | All criteria passed |
| Unit, Integration, and System Level/General Verification Software Testing | All criteria passed |
| QCA Verification | All criteria passed |
| IVUS Co-Registration Verification | All criteria passed |
| FM Co-Registration Verification | All criteria passed |
| Software Validation (FM Co-Registration Visual Validation) | All criteria passed |
| Usability Validation (Simulated Use, Design & Usability/Human Factors Engineering Validation Test) | All criteria passed |
2. Sample Size for the Test Set and Data Provenance
The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective) because this submission is for software modifications to an existing device. Instead, it refers to internal software verification and validation activities. These tests would typically use simulated data, previously acquired clinical data (from the predicate device or other sources), or a combination thereof to evaluate the new software's functionality. The details of these internal test data sets are not disclosed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the summary. For software verification and validation, ground truth would be established by comparing the software's output against expected results in simulated scenarios or against data with known ground truth (e.g., manually calculated measurements or outputs from the predicate device). The expertise required would depend on the nature of the specific test.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. Given that this is a software verification and validation submission for modifications, it's likely that internal quality control processes, including expert review and comparison to established benchmarks or predicate device performance, would have been used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and described in this document. The submission focuses on demonstrating substantial equivalence of the modified software to the predicate device through non-clinical performance testing.
6. Standalone Performance (Algorithm Only)
Yes, a standalone (algorithm only) performance assessment was inherent in the "Software Verification" and "Software Validation" mentioned. These tests evaluate the software's functionality and accuracy independent of human interaction, though "Simulated Use" would involve human interaction to assess usability. The document confirms that various components of the software, such as QCA, IVUS co-registration, and FM co-registration, underwent verification and validation.
7. Type of Ground Truth Used
The specific types of ground truth for the internal software verification and validation are not detailed in this summary. However, for a device like SyncVision, which performs quantitative measurements and co-registration, the ground truth for these tests would likely involve:
- Known input parameters and expected output calculations for quantitative analysis (QCA, measurements).
- Reference standard alignments or known spatial relationships for co-registration components (IVUS co-registration, FM co-registration).
- Comparison to the performance of the predicate device for functional equivalence.
8. Sample Size for the Training Set
The document does not mention a training set, as it is a 510(k) submission for software modifications to a previously cleared device, not a de novo algorithm development. If the modifications involved machine learning components, a training set would be relevant, but such details are not provided here.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not applicable and not provided in the document.
§ 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.