(56 days)
The Sync-Rx 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.
The Sync-Rx System is an image acquisition and processing workstation situated in the coronary catheterization lab and intended to be used during coronary catheterizations. The Sync-Rx System captures the fluoroscopic image stream and performs the following for assisting the interventional cardiologist: Lesion Evaluation: The system performs angiogram selection and quantitative coronary measurements (lesion diameter, vessel diameter, lesion length, percent stenosis). Device positioning, deployment and post-deployment: An on-line enhanced image stream is displayed side-by-side to the existing fluoroscopic image stream. All functions performed by the Sync-Rx System are presented, both in the procedure room and in the control room, on a display that is situated side by side to the already-existing display of the native fluoroscopic image stream.
The provided text for the Sync-Rx System 510(k) Summary and FDA clearance letter does not contain a detailed description of acceptance criteria or a specific study proving the device meets those criteria.
However, based on the information provided, we can infer some general aspects of the performance and the type of testing conducted.
Here's an attempt to structure the information based on your request, highlighting what is implicitly or explicitly mentioned and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Explicit) | Reported Device Performance (Inferred/Explicit) |
|---|---|---|
| Functional Specifications | Meets all functional specifications | Device meets all its functional specifications. |
| Intended Use | Fit for its intended use | Device is fit for its intended use. |
| Industry Standards | Complies with industry standards | Device complies with industry standards. |
| Safety Standards | Complies with safety standards | Device complies with safety standards. |
| Quantitative Information | Provides quantitative information regarding calculated dimensions of arterial segments. | The system effectively performs quantitative coronary measurements (lesion diameter, vessel diameter, lesion length, percent stenosis). |
| Enhance Visualization | Enhances visualization of the stent deployment region. | Provides an on-line enhanced image stream displayed side-by-side to the existing fluoroscopic image stream. |
| Software Validation | Software functions correctly and reliably. | Subjected to "Software Verification and Validation Tests" and "Sync-Rx System Usability Validation". |
| QCA Validation | Quantitative Coronary Angiography (QCA) measurements are accurate and reliable. | "Sync-Rx System QCA Validation" was performed. Specific metrics like accuracy, precision, or correlation were not provided. |
| Electrical Safety | Meets electrical safety requirements. | "Electrical Safety" testing was performed. |
| EMC | Meets electromagnetic compatibility requirements. | "Electromagnetic Compatibility" testing was performed. |
| Mechanical Compliance | Input devices are mechanically compliant. | "Input Device Mechanical Compliance" testing was performed. |
| Design Verification | Design meets specified requirements. | "Sync-Rx System Design Verification" was performed. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: This information is not provided in the document. The text mentions "various performance tests" and "Final testing," but no specific sample sizes for cases or measurements are given.
- Data Provenance: This information is not provided. It is not specified if the data used for the tests was from a specific country, or if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: This information is not provided.
- Qualifications of Experts: This information is not provided.
4. Adjudication Method for the Test Set
- This information is not provided.
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 an MRMC comparative effectiveness study or any studies comparing human reader performance with and without AI assistance. The device description focuses on the system assisting the interventional cardiologist, but no performance improvement metrics for human readers are provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document mentions "Sync-Rx System QCA Validation" and "Software Verification and Validation Tests," which typically involve evaluating the algorithm's performance. The "Lesion Evaluation" function specifies that "The system performs angiogram selection and quantitative coronary measurements." This suggests that the algorithm performs these tasks in a standalone manner, providing output to the user. However, specific standalone performance metrics (like sensitivity, specificity, accuracy for QCA) are not reported.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The document mentions "Sync-Rx System QCA Validation." For QCA, ground truth is typically established by:
- Expert measurements/consensus: Manual measurements by experienced cardiologists or technicians, often considered the gold standard for comparison.
- Phantom studies: Using precisely manufactured phantoms with known dimensions.
- In-vitro measurements: Direct measurements of vessels or lesions in a controlled setting.
- The specific type of ground truth used for the QCA validation and other performance tests is not explicitly stated.
8. The Sample Size for the Training Set
- The document provides information on testing/validation but does not mention a training set or its sample size. This is common for 510(k) summaries where the focus is on validation rather than AI model development details. Given the date of the submission (2010), the term "AI" might not have been prevalent in regulatory submissions, and the system might rely on more conventional image processing algorithms rather than deep learning requiring extensive training data.
9. How the Ground Truth for the Training Set was Established
- As no training set is mentioned (see point 8), this information is not applicable/provided.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.