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The Sync-Rx System is an image acquisition and processing system. It is indicated for use as follows:

• a) To provide quantitative information regarding the calculated dimensions of arterial segments.
• b) To enhance visualization of the stent deployment region.
• c) To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
• d) To obtain a co-registration of an angiographic x-ray image and IVUS images.

The modified 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 modified Sync-Rx System captures the angiographic and intrasound (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) and vessel region enhancement and vessel region stabilization are performed instantly and on-line.
• During device positioning, 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).

All functions performed by the modified Sync-Rx System are presented, both in the procedure room and in the control room, on a computer display that is situated directly next to the existing display of native angiographic and IVUS image streams. The modified Sync-Rx System operates by means of multiple software modules and associated algorithms interacting with one another and responsible for the on-line acquisition, processing and display of coronary image frames.

The most significant change to the modified Sync-Rx System, and the reason for this 510(k) submission, is the addition of the capability to display and co-register another native image stream. IVUS. The addition of the co-registered IVUS image stream is intended to automate manual registration processes currently performed in the coronary catheterization lab and to provide a simple means to view both the angiographic and IVUS image streams on adjacent windows on a single computer display.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Volcano Corporation's modified Sync-Rx™ System:

Summary of Device Performance Study

The provided 510(k) summary for the modified Sync-Rx System (K132558) describes the device as an image acquisition and processing workstation for use in coronary catheterization labs. The most significant change in this modification is the addition of Intravascular Ultrasound (IVUS) image stream display and co-registration with angiographic images. The submission asserts substantial equivalence to predicate devices (Sync-Rx System, K100849, and Artis Q, K123529).

Regarding performance testing, the document states that the modified Sync-Rx System underwent safety, performance, verification, and validation testing. Specifically for the new IVUS co-registration and quantitative measurements, the submission claims that the same statistical methods used for the unmodified system's angiogram QCA measurements were applied to establish the accuracy and precision of the IVUS QCA measurements (length and diameter). It also mentions "Co-registration Validation - Phantom Based Simulated Environment."

However, the document does not explicitly state specific acceptance criteria or provide a detailed table of results for the device performance against such criteria. It generally asserts that "Performance data demonstrates that any differences in the available intra-luminal measurements between the modified Sync-Rx System and the Artis Q do not raise questions of substantial equivalence."

Detailed Information Extracted from the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (Inferred from general statements)	Reported Device Performance
   Accuracy and precision of IVUS QCA measurements (length and diameter)	"The same statistical methods that were employed in the unmodified System to establish the accuracy and precision of the angiogram QCA measurements were employed in the modified System to establish the accuracy and precision of the IVUS QCA measurements (length and diameter). Therefore, the accuracy and precision of the IVUS measurements do not raise questions of substantial equivalence." (No specific numerical values provided in this summary.)
   Functional requirements and intended uses fully met	"Final testing of the modified Sync-Rx System included various performance tests and software validation tests, designed to ensure that the device met all of its functional requirements and intended uses." (Specific details of "functional requirements" and how they were met are not provided.)
   Compliance with applicable industry and safety standards (listed IEC/UL, ISO standards)	"Tests have been performed to ensure that the device complies with all applicable industry and safety standards." (Compliance with specific standards like IEC/EN/UL 60601-1, IEC/EN 60601-1-2, IEC 60601-1-6, IEC 62366, IEC 62304, and ISO 15223 is asserted, but no test results are presented.)
   Co-registration accuracy	"Co-registration Validation - Phantom Based Simulated Environment" was performed. (No specific accuracy metrics or results from this validation are given in the summary.)
   Usability	"Sync-Rx System Usability Validation" was performed. (No specific outcomes or metrics from usability validation are presented.)
   Safety (Electrical Safety, Electromagnetic Compatibility)	"Electrical Safety" and "Electromagnetic Compatibility" tests were performed. (No specific results or parameters for safety testing are provided.)
   No new questions of substantial equivalence	The document repeatedly asserts that the modifications do not raise new questions of substantial equivalence based on the testing performed and comparison to predicate devices, particularly the Artis Q system's existing co-registration of angiogram and IVUS images.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify an exact sample size (e.g., number of patients, images, or phantom runs) for the tests. It mentions "phantom based simulated environment" for co-registration validation.
   • Data Provenance: Not explicitly stated for specific test data. The submission indicates that "Animal test data and clinical data were not required to demonstrate substantial equivalence." This implies that the validation primarily relied on bench testing, phantom studies, and possibly existing data or characterization of the algorithm's performance on a simulated or internal dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document does not provide information on any adjudication method used 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:

   • No MRMC comparative effectiveness study is mentioned. The device is presented as an aid to interventional cardiologists ("assisting the interventional cardiologist") and simplifies workflow ("automate manual registration processes," "simple means to view both... on single computer display"), but no studies on improved human reader performance with the device compared to without it are presented or referenced. "Animal test data and clinical data were not required."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The "Co-registration Validation - Phantom Based Simulated Environment" and "IVUS QCA measurements" accuracy and precision testing likely represent standalone algorithm performance checks, as they would assess the algorithm's output against a known or simulated ground truth without direct human interpretation being the primary variable. However, it's not explicitly framed as a "standalone study" in the common sense of an AI performance report.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the co-registration validation, a phantom-based simulated environment was used, implying a precisely known ground truth for validation.
   • For IVUS QCA measurements, the ground truth source is not explicitly stated, but it would typically involve physical measurements of phantoms or carefully calibrated reference images, similar to how the unmodified system's angiogram QCA measurements were validated.
   • No expert consensus, pathology, or outcomes data are mentioned as ground truth.

8. The sample size for the training set:

   • The document does not provide information on a training set sample size. This is a 510(k) for a modified device, and while it uses algorithms, the submission focuses on verifying the modifications (primarily IVUS co-registration and QCA). The original algorithms would have been developed and "trained" prior to the initial K100849 submission, and that information is not part of this summary for the modified device. Also, the term "training set" is more common in machine learning or deep learning contexts, which may not have been the primary methodology for the underlying algorithms at the time of this submission (2013).

9. How the ground truth for the training set was established:

   • As no training set information is provided, how its ground truth was established is also not documented in this 510(k) summary.

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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

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.

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