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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 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:

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.

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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.

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.

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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.
• 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.

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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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