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The Verrata PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.

The provided document does not contain all the requested information for acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for the Verrata PLUS Pressure Guide Wire and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a clinical study with specific acceptance criteria and detailed performance statistics.

Here is the information that can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All device acceptance criteria were met" and that the device "meets its intended use." However, it does not provide a specific table of quantitative acceptance criteria values or the corresponding reported device performance values. It lists types of performance testing completed.

The comparison table on page 4-5 explicitly states that for "Sensor" attributes, the "Accuracy," "Drift," and "Operating Range" are "SAME" as the predicate device (Verrata PLUS Pressure Guide Wire, K161887). This implies that the acceptance criteria for these sensor-related performance metrics are identical to those established for the predicate device, and the subject device achieved performance equivalent to the predicate.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench and laboratory-based design verification and system verification, not human clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document describes performance testing, likely against established engineering and technical standards, rather than expert-established ground truth from clinical data.

4. Adjudication Method for Test Set:

Not applicable. There is no indication of an adjudication method for a test set, as no clinical study or expert review for ground truth establishment is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned or implied. The device is a pressure guide wire, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical medical instrument (pressure guide wire) meant for use in conjunction with other systems and interventional procedures, not a standalone algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing cited would be based on established engineering specifications, calibration standards, and industry-recognized testing methodologies for medical devices, particularly pressure sensors and guide wires. This is not explicitly stated but is inferred from the types of tests listed (EMC, Electrical Safety, Design Verification, Shelf Life, Drift, System Verification).

8. Sample Size for Training Set:

Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for this device.

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The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.

The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The IntraSight Mobile System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight Mobile System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires.

When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).

The provided text describes a 510(k) premarket notification for the "IntraSight Mobile" system, which is a modification of an already cleared device, "IntraSight System" (K190078). This document primarily focuses on establishing substantial equivalence to the predicate device due to a functional modification (making it mobile). As such, it does not contain the kind of detailed information about acceptance criteria for AI/ML-enabled device performance and the extensive clinical study data (sample sizes, expert qualifications, MRMC studies, ground truth establishment) typically required for novel AI device submissions.

The "Performance Data" section lists various engineering and software verification and validation activities, but these are general product development tests and not specific to AI/ML performance. The "Conclusion" statement, "All device acceptance criteria were met," refers to these engineering and usability tests, not to a clinical AI/ML performance study.

Therefore, many of the requested details about acceptance criteria and study proving device performance for an AI/ML device cannot be extracted from this document, as it is a 510(k) for a modified hardware platform rather than a new AI/ML software feature.

However, I can extract the available information:

1. A table of acceptance criteria and the reported device performance:

Based on the provided text, the acceptance criteria are implicitly that the device performs as intended and meets safety and effectiveness standards, demonstrating substantial equivalence to the predicate. The performance data listed are general engineering and validation tests, not specific quantitative AI/ML performance metrics.

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

• Test Set Sample Size: Not specified for any clinical or AI/ML performance testing, as it's a hardware modification submission. The listed tests are engineering/software verification.
• Data Provenance: Not applicable/specified for AI/ML performance data, as such data is not detailed in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The submission focuses on device modifications and substantial equivalence to a predicate, not novel AI/ML algorithm performance.

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

• Not specified. This level of detail on clinical study methodology is not present, as the submission is for a device modification.

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 study information is provided. This submission is for a hardware modification, not a new AI-assisted workflow.

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

• No standalone algorithm performance data is provided.

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

• No specific ground truth type is mentioned as no AI/ML performance study is detailed. The "Image Validation" likely refers to ensuring image quality is comparable to the predicate.

8. The sample size for the training set:

• Not applicable/specified, as this submission concerns a hardware modification of an existing device, not the development or training of a new AI/ML model.

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

• Not applicable/specified, as this submission does not detail the training of an AI/ML model.

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The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and CORE Series of systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.

This document is a 510(k) summary for the OmniWire Pressure Guide Wire (K202543). It indicates that the device is substantially equivalent to a previously marketed predicate device (OmniWire Pressure Guide Wire, K192886).

Based on the provided information, the device is a pressure guide wire, and the 510(k) is for demonstrating its substantial equivalence. The document explicitly states that no new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission. Therefore, the information regarding acceptance criteria and studies demonstrating that the device meets these criteria is very limited to what is typically found in a clinical study report.

However, the document does contain information about non-clinical testing (bench testing) that was conducted. This bench testing serves as the "study" proving the device meets certain acceptance criteria related to its design, electrical safety, electromagnetic compatibility, and aging.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing)

Note: The document states that the subject device and the predicate device have identical design, materials, physical properties, and performance specifications. This implies that the acceptance criteria for these physical and performance specifications are met if they are identical to the already cleared predicate device. Specific numerical acceptance criteria for these physical properties are not listed as distinct "acceptance criteria" but are stated as identical to the predicate's known specifications.

Other Requested Information:

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

• Test Set Sample Size: Not explicitly stated for specific non-clinical tests. The document mentions "Bench testing was completed as part of design verification."
• Data Provenance: Not specified, but generally, bench testing data for medical devices originates from the manufacturer's testing facilities (Volcano Corporation in this case). The document is a 510(k) submission, not a detailed test report. The general context suggests lab-based, pre-market non-clinical testing. It is retrospective in the sense that results are reported after testing is completed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of this 510(k) submission. For non-clinical bench testing, "ground truth" is typically established by engineering specifications, calibration standards, and established testing methodologies (e.g., ASTM, ISO standards) rather than expert consensus on a test set. This type of analysis (expert review to establish ground truth) is more common in clinical studies, especially those involving image interpretation or diagnostic accuracy by human readers.

4. Adjudication method for the test set:

• Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are primarily used in multi-reader studies to resolve discrepancies in expert interpretation, which is not the nature of the non-clinical bench testing described.

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 study was done. The document explicitly states: "No new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." This device is a physical medical device (pressure guide wire), not an AI-powered diagnostic tool, so an MRMC study comparing human performance with and without AI assistance would not be relevant.

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

• Not applicable. This device is a physical medical device for measuring pressure, not a standalone algorithm.

7. The type of ground truth used:

• For the non-clinical testing: The ground truth is engineering specifications, calibrated instruments, and established industry test standards (e.g., for electrical safety, EMC, material properties). The device's performance was compared against these predefined physical and functional requirements.

8. The sample size for the training set:

• Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The "training" for such a device involves its design and manufacturing processes to meet specifications.

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

• Not applicable. See explanation for #8.

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The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and SmartMap systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or preshaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.

The provided text describes the OmniWire Pressure Guide Wire and its substantial equivalence to a predicate device (Verrata PLUS Pressure Guide Wire, K161887). The information regarding acceptance criteria and the study proving the device meets them is primarily found in the "Summary of Non-Clinical Testing" section.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Performance bench testing was completed as part of design verification to establish Substantial Equivalence with the predicate device, and that the subject device performs as intended." It then lists the types of tests conducted. However, it does not explicitly state the specific acceptance criteria (e.g., numerical thresholds, pass/fail rates) or the numerical results of each test. It only indicates that the device met these requirements.

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

The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of guidewires tested for tensile strength, number of animals in the GLP study). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) beyond stating they were "performance bench testing" and a "GLP Animal Study."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The non-clinical tests described are primarily engineering and performance evaluations, and do not necessarily involve expert "ground truth" in the same way a diagnostic AI might. For the GLP Animal Study, expert veterinarians or researchers would have been involved, but their number and specific qualifications are not detailed.

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

This information is not provided in the document. Given the nature of the non-clinical tests, a formal adjudication method like those used for clinical image interpretation studies is unlikely to be applicable or necessary.

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 was done. The document explicitly states: "No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k) submission." This device is a pressure guide wire, not an AI-assisted diagnostic tool for human readers.

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

The device is a physical medical device (pressure guide wire) used to measure pressure. It is not an algorithm or AI that operates "standalone" in the typical sense of AI performance evaluation. Its performance is inherent in its physical and pressure-sensing capabilities, which were evaluated through the non-clinical tests mentioned.

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

For the non-clinical tests (tensile strength, torque strength, etc.), the "ground truth" would be established by physical measurements against engineering specifications and industry standards. For the GLP Animal Study, the "ground truth" would be the physiological measurements and observations recorded by trained personnel, likely assessed against expected physiological responses. It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.

8. The sample size for the training set:

This information is not applicable/not provided. This device is not an AI algorithm that undergoes a "training set" in the machine learning sense. Its design and performance are based on engineering principles and materials science.

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

This information is not applicable/not provided for the same reason as point 8.

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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 IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.

The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The IntraSight System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires. When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from a pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).

The provided text is a 510(k) summary for the Volcano IntraSight System, which is an imaging and pressure measurement system used in coronary and peripheral vasculature. The document clarifies that the IntraSight System is a modification of an already marketed device (Volcano s5i/CORE and CORE Mobile Precision Guided Therapy Systems, K173860). The focus of the 510(k) summary is to demonstrate substantial equivalence to the predicate device due to these modifications, not to establish the initial performance of a novel device.

Therefore, the summary primarily describes verification and validation activities conducted to ensure the modified device meets its specifications and remains substantially equivalent to the predicate, rather than presenting a standalone study with specific acceptance criteria and performance metrics for an AI/algorithm-driven device in the way a new diagnostic or prognostic AI algorithm would be evaluated.

Based on the provided information, I can answer some of your questions, but many cannot be answered because the document does not contain the details of a comparative effectiveness study or a standalone algorithm performance study with specific clinical acceptance criteria and results. It primarily mentions engineering and software verification activities.

Here's an attempt to answer based on the given text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for clinical performance or reported device performance in the context of an AI/algorithm-driven diagnostic or prognostic task. The "Performance Data" section lists types of engineering and software verification tests performed (e.g., EMC, Electrical Safety, Environmental, Design Verification, Software Verification and Validation, Packaging Validation, Simulated Use/Usability Validation, Image Validation). These are not clinical acceptance criteria with specific performance metrics (like sensitivity, specificity, or AUC) as you would find for an AI study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document lists "Image Validation" as a type of performance data, but it does not specify the sample size, data provenance, or whether it was a test set for an algorithm. Given the nature of a 510(k) for modifications to an existing device, "Image Validation" likely refers to ensuring image quality equivalence or non-inferiority compared to the predicate, rather than a clinical study of an AI algorithm on a specific test set.

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)

This information is not provided. There is no mention of a test set with ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in the provided text. The document describes modifications to an existing imaging system (IntraSight System) and seeks substantial equivalence, not the clinical effect of an AI component on human performance.

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

A standalone algorithm performance study is not mentioned. The IntraSight System itself is a device that includes hardware and software for imaging and pressure measurement, intended for use by clinicians, not a standalone AI algorithm being evaluated for accuracy independent of human interaction.

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

This information is not provided. There is no mention of ground truth in the context of an AI algorithm evaluation.

8. The sample size for the training set

This information is not provided. The document does not describe the development or training of an AI algorithm in the context you are asking about. The "Software Verification and Validation" mentioned refers to the standard software development lifecycle for the device's operating system and features.

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

This information is not provided.

In summary: The provided 510(k) summary is for a device system (IntraSight System) that underwent modifications, including updated hardware and software platforms. The "Performance Data" listed primarily pertains to engineering and software verification and validation activities to ensure the modified device remains substantially equivalent to its predicate. It does not present a clinical study evaluating the performance of an AI-driven diagnostic or prognostic algorithm with specific acceptance criteria, test sets, ground truth establishment, or human reader studies. Therefore, most of your questions, which are tailored to the evaluation of an AI algorithm's clinical performance, cannot be answered from this document.

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The Volcano System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.

The FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The Volcano s5 TM/s5i/CORETM Mobile Precision Guided Therapy System is a mobile imaging and pressure management system as previously described in K133323. The subject device incorporates the Volcano iFR® Modality cleared in K133323.

Pressure measurement is captured through the use of currently marketed pressure wires compatible with the currently marketed s5/s5i/CORE/CORE Mobile imaging and pressure measurement system.

This FDA 510(k) submission describes the Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System and focuses on a change in the Indications for Use for its iFR Modality. The submission aims to adopt a new, single diagnostic cut-point for iFR guided revascularization based on recent clinical evidence, replacing a previous 'hybrid' approach.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here re-frame the iFR Modality's diagnostic cut-point. The previous approach was likely a range (e.g., 0.75-0.80), and the new acceptance criteria is a single, dichotomous cut-point of 0.89. The device performance is evaluated against this new cut-point in terms of its clinical outcomes compared to FFR guidance.

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The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The CORE M2 Vascular System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional grayscale image.

In addition to producing grayscale IVUS images, the CORE M2 System with Software v4.2 provides the ChromaFlo feature which can be used to identify blood flow. The ChromaFlo feature uses patented technology to provide a visual depiction of blood flow through the vessel. This is accomplished by overlaying a two-dimensional color mapping of relative blood flow velocity on to the grayscale ultrasound image.

The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.

The provided document, a 510(k) summary for the CORE M2 Vascular System Software v4.2, describes several verification and validation activities. However, it does not include detailed acceptance criteria or a specific study that quantifies device performance against those criteria in the typical format of a clinical or analytical performance study with metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on demonstrating that the software modifications maintain substantial equivalence to a predicate device. The performance data presented are primarily engineering and system-level validations, as well as qualitative assessments of clinical acceptability.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't provide a quantitative table of acceptance criteria and reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm. Instead, the performance data focuses on system functionality and image quality.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not specified for any of the validation steps. The document refers to "testing" without providing numerical sample sizes for cases, images, or subjects.
• Data Provenance: Not specified. It's unclear if the data used for image validation or acoustic output comparison was from a specific country or if it was retrospective or prospective. Given the nature of a 510(k) for software updates to an existing system, it's likely previous data and newly acquired bench/phantom data were used.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document mentions "clinically acceptable for end users" in the Image Validation section, implying clinical assessment, but the details of who performed this or their qualifications are absent.

4. Adjudication Method for the Test Set

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was not performed or reported in this summary. The device, the "CORE M2 Vascular System Software v4.2," including its "ChromaFlo" feature for qualitative blood flow information, is not presented as an AI-assisted diagnostic tool that augments human interpretation in a comparative effectiveness setting. It's a system for image acquisition and display, with ChromaFlo providing a visual depiction of blood flow.

6. Standalone (Algorithm Only) Performance Study

No. The document describes system-level validations and image quality assessments, but not a standalone performance study of an AI algorithm in the typical sense (e.g., measuring its diagnostic accuracy independently). The ChromaFlo feature is part of the system and provides "qualitative blood flow information" as an "adjunct to other methods," suggesting it's not intended for standalone diagnostic interpretation.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance (e.g., pathology, outcomes data) is not directly addressed in this document. The validations are more about:

• Engineering specifications ("meets specifications").
• Equivalence to a predicate device ("substantially equivalent").
• Meeting user needs ("meets user needs").
• Clinical acceptability ("clinically acceptable for end users").

For the "Image Validation" and "Simulated Use/Usability Validation," the "ground truth" would be the subjective judgment of clinical acceptability and usability by qualified individuals (though not specified). For acoustic output, it would be measured physical properties compared to established standards or the predicate.

8. Sample Size for the Training Set

Not applicable/Not specified. This document is about software modifications to an existing device, including the addition of a feature (ChromaFlo). It does not describe the development or training of a de novo AI algorithm with a distinct training set. The ChromaFlo feature uses "patented technology to provide a visual depiction of blood flow velocity," implying a predefined method rather than a machine learning model requiring a training dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI algorithm appears to have been used in the context of this 510(k) submission for software updates.

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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 CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

The CORE M2 Vascular System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional image.

The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.

The provided text describes the Volcano CORE M2 Vascular System, an ultrasonic pulsed echo imaging system. The performance data section outlines the design verification, software verification and validation, simulated use/usability validation, and image validation conducted to support the substantial equivalence claim to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for test sets in most categories.

• Design Verification: Details are general about testing performed on "the CORE M2 system" or "each of its subassemblies" or "each of the CORE M2 System packages." Specific numbers of units tested are not provided.
• Software Verification and Validation: Mentions "Unit, integration, and system level software testing was conducted on the CORE M2 v4.1 software." No specific number of test cases or cycles is provided.
• Simulated Use / Usability Validation: The text implies testing with users ("demonstrates that users are able to use the device safely and effectively"), but does not state the number of users or scenarios.
• Image Validation: The text states "An Image Validation was also conducted to confirm that the images acquired and displayed by the CORE M2 System are clinically acceptable for end users." No specific number of images or patients for this validation is provided.

Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal verification by Volcano Corporation rather than external clinical data. The studies described are likely prospective in nature, as they involve testing the device against predefined specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number or qualifications of experts specifically used to establish ground truth for the test set in the same way one might describe a clinical study comparing diagnostic accuracy.

• For Image Validation, it mentions "clinically acceptable for end users," implying clinical judgment, but does not specify how many clinicians or what their qualifications were.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for any of the performance data tests. The evaluations described are primarily engineering and software verification against specifications, or general statements about clinical acceptability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The performance data focuses on validating the device's technical specifications and image quality, not its impact on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

The device itself is an "Ultrasonic Pulsed Echo Imaging System" which provides images for a human to interpret. Therefore, the concept of a "standalone" algorithmic performance (without human-in-the-loop) in the context of an imaging system's primary output is not directly applicable in the way it would be for an AI diagnostic algorithm. The system itself (hardware + software for image generation) is being evaluated for its standalone ability to acquire and display clinically acceptable images. The section "Image Validation" could be interpreted as evaluating the standalone image quality generated by the system.

7. The Type of Ground Truth Used

• Design Verification: Ground truth for these tests (electrical safety, EMC, environmental, packaging, hardware) would be the engineering specifications and industry standards (e.g., ANSI/AAMI, IEC, ASTM) that the device must meet.
• Software Verification and Validation: Ground truth would be the defined software requirements.
• Simulated Use / Usability Validation: Ground truth would be user needs and safety requirements.
• Image Validation: Ground truth appears to be expert consensus on "clinical acceptability" of the images, although the specifics are not detailed.

8. The Sample Size for the Training Set

The document does not describe any machine learning components that would require a distinct "training set." The CORE M2 Vascular System is an ultrasonic imaging system, and its development and validation are described in terms of engineering, software, and image quality verification, not in terms of training an AI model on a dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of machine learning, this question is not applicable.

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