(32 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 IVUSimages.
- To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.
The SyncVision System (the System) is an image acquisition and processing workstation situated in the coronary catheterization laboratory and is intended to be used during coronary catheterization procedures. The SyncVision System captures angiographic and intravascular ultrasound (IVUS) image streams, as well as physiological (FFR/iFR) displayed value streams, and works in conjunction with currently marketed Volcano IVUS Systems.
The SyncVision System intends to capture the fluoroscopic image stream on line and perform the following functions in order to assist interventional cardiologist in visualizing and quantifying the information resulting from images produced by the existing imaging modalities:
- . During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and percent stenosis) and vessel region enhancement are performed instantly and on line.
- . During device positioning, deployment and post-deployment, an on-line enhanced image stream is displayed side-by-side to the existing Fluoroscopic image stream.
- Import and display of image data from endoluminal modalities, lead to a joint display of images acquired by X-ray and endoluminal imaging, and correspond to the same selected luminal locations or segments (also known as co-registration of such modalities).
- Import and display of values derived from intracoronary pressure measurements lead to a joint display of images acquired by X-ray and pressure values, and correspond to the same selected locations or segments (also known as co-registration of such modalities).
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 provided text is a 510(k) Summary for the Volcano Corporation's SyncVision System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or standalone performance study.
Therefore, the information required to answer most of the questions, particularly regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, expert qualifications for ground truth, and adjudication methods, is not present in this document. The document explicitly states:
"The SyncVision System did not require clinical data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes:
- Indication for use;
- Technological characteristics;
- Non-clinical performance testing; and
- Safety and effectiveness."
"Completion of these tests and the differences between the new SyncVision System and the predicate device SyncVision System do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the SyncVision System is considered substantially equivalent to the currently marketed predicate device."
However, I can extract information about the non-clinical performance testing which serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission for demonstrating substantial equivalence.
Here's what can be extracted and what cannot:
Acceptance Criteria and Study for SyncVision System (K190626)
Based on the provided 510(k) Summary, the "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence through non-clinical performance testing, rather than a de novo clinical trial with specific performance metrics against a medical condition.
1. A table of acceptance criteria and the reported device performance:
The document describes the types of tests performed but does not provide specific quantitative acceptance criteria or detailed reported performance metrics in a table format. It generally states:
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Verification and Validation (Unit, Integration, System Level/General) | Meets defined software specifications and functional requirements. | "The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." |
| QCA Verification | Accurate Quantitative Coronary Analysis (QCA) measurements. | "The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." |
| IVUS Co-Registration Verification | Accurate co-registration between IVUS images and angiograms. | "The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." |
| FM Co-Registration Verification | Accurate co-registration with physiological measurements. | "The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." |
| Usability Validation | Meets usability and human factors requirements. | "The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." |
| Simulated Use, Design & Usability/Human Factors Engineering Validation Test | Acceptable performance in simulated clinical scenarios. | "The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The non-clinical performance testing likely used a set of pre-recorded or simulated data, but the number of cases or data points is not mentioned.
- Data Provenance: Not specified. It's likely internal company data for verification and validation, but no country of origin is mentioned. The testing was "non-clinical," implying it was not derived from patient data in a publically reported clinical study, but rather from internal development and engineering tests. The document states it did not require clinical data.
- Retrospective or Prospective: Not applicable, as this was non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For non-clinical software verification, "ground truth" might be established by engineering specifications, known algorithmic outputs, or comparison to results from the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. For non-clinical software testing, formal adjudication methods as seen in clinical trials are typically not employed.
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:
- MRMC Study: No. The document explicitly states that the device "did not require clinical data" and implies that no such comparative effectiveness study was performed as part of this 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The verification and validation testing, particularly for QCA, IVUS co-registration, and FM co-registration, would involve "algorithm only" performance evaluation against predefined criteria or the predicate device's behavior. However, specific standalone performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic task) are not provided beyond the general statement of "passing results." The document focuses on feature and workflow enhancements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated. For "QCA Verification," "IVUS co-Registration Verification," and "FM Co-Registration Verification," the ground truth was likely established by the known true values or expected outputs of the algorithms, possibly derived from highly accurate manual measurements or comparison to the predicate device's proven performance. It was not clinical ground truth (e.g., pathology, outcomes).
8. The sample size for the training set:
- Training Set Sample Size: Not applicable/not specified. The document does not describe the use of machine learning or AI models that would require a distinct training set. The descriptions of "digital edge detection by calculation of the derivatives (or gradients) of the density curve" suggest a more traditional image processing approach rather than a data-driven AI model that needs a training phase, though such models could be integrated. Given the focus on "software modifications" rather than a new core algorithm, a specific training set akin to deep learning is unlikely to be discussed in a 510(k) for substantial equivalence if the underlying principles are unchanged.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as no training set for an AI/ML model is mentioned.
§ 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.