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The Volcano s5/s5i Series Intravascular Imaging and Pressure 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 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 wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

ComboMap™ Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.

Volcano s5/s5i Series Intravascular Imaging and Pressure System: This system is available in 3 configurations; 1) a tower or portable model, 2) an integrated model, and 3) an integrated model with communication capabilities with 3rd party angiography equipment. When operating in IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees. When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II and ComboWire II) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment.

ComboMap Pressure and Flow System: The ComboMap™ Pressure and Flow System is a computer-controlled (PC-based) instrument, which processes the information it receives from the transducer mounted in a Volcano Corporation SmartWireR Pressure Guide Wire (K021219), Volcano Corporation FloWireR Doppler Guide Wire (K905411, K912776, K921563, K972762), and/or external inputs, to produce real-time blood pressure and/or blood flow velocity. There are 4 modes available to operate from and switch between on the ComboMap™; System, Pressure, Flow, and Combo. Depending on the mode and setup selections made, the computer screen displays a combination of waveforms, measured values, and calculated parameters on the display screen. Additional controls also appear on the display screens. In the Pressure Mode, the ComboMap™ provides digital and graphical readout of mean aortic pressure from a guide catheter, mean SmartWireR pressure, and a calculated parameter, such as gradient or fractional flow reserve (FFR), and one of six (6) selected waveforms. The ComboMap™ also supplies an analog output of the SmartWireR pressure for display on a conventional physiologic monitoring system. In the Flow Mode, there are two (2) operating modes to measure blood flow velocity in either coronary or peripheral vessels. This is because in coronary arteries, maximum blood flow velocity occurs predominantly during diastole and in peripheral arteries, maximum flow occurs during systole. The ComboMap™ displays the waveforms selected and provides digital readout of calculated parameters such as average peak velocity (APV) and flow reserve. The ComboMap™ System offers the unique ability to simultaneously display pressure and velocity waveforms using the Combo Mode. Layout of the Pressure and Doppler display as well as selected waveforms is customized by the user allowing a combination of any of those described above in Pressure Mode and Flow Mode.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Volcano s5/s5i Series Intravascular Imaging and Pressure Systems and ComboMap Pressure and Flow System:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on a general statement about compliance with internal procedures and a conclusion of substantial equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

The provided 510(k) summary is a premarket notification for substantial equivalence, which primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. It does not contain details of a clinical study or a performance study with specific quantitative results as would be typically found for novel devices or those requiring a PMA.

Here's what can be inferred or explicitly stated based on the text provided:

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

• Not specified. The document refers to "applicable testing" and "test plans and protocols" but does not provide details on the sample size of any test sets (e.g., patient data, phantom studies, etc.) or the provenance of any data used for performance validation.

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)

• Not specified. Given the nature of a 510(k) summary for substantial equivalence, it's unlikely that external experts were used to establish ground truth in the way one might for a novel diagnostic algorithm. The "ground truth" for showing substantial equivalence likely refers to the established performance of the predicate devices and internal validation processes against engineering specifications.

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

• Not specified.

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 evidence of an MRMC study. This submission predates the widespread regulatory focus on AI-driven clinical decision support and MRMC studies for such tools. The devices are described as imaging and pressure/flow systems, not AI-assisted diagnostic tools in the modern sense. The "VH IVUS" feature includes semi-automatic visualization and spectral analysis, which hints at some automated processing, but an MRMC study exploring human improvement with this feature is not mentioned.

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

• Implied for some components, but not explicitly detailed. The devices are systems that acquire and display data (IVUS images, pressure/flow readings). The "semi-automatic visualization" and "spectral analysis" features of VH IVUS likely involve algorithms operating in a standalone capacity within the system to process data before presentation to the user. However, no specific standalone performance metrics for these algorithmic components are provided.

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

• Not specified directly. For an imaging system, ground truth would typically come from a combination of:
  • Predicate device comparison: The performance is benchmarked against the cleared predicate devices.
  • Physical phantoms/simulators: For sensor accuracy (pressure, flow) and imaging resolution.
  • Clinical observation: The ability to visualize structures and measure physiological parameters in patients, likely compared with established clinical methods.
    The document only broadly states "applicable testing was performed as required by the Quality System to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols."

8. The sample size for the training set

• Not applicable / Not specified. This submission is for hardware systems and their associated software for data acquisition and display. It does not describe a machine learning model that would require a "training set" in the modern AI sense. While some algorithms (like those for semi-automatic visualization or spectral analysis) might have been developed using data, the concept of a "training set" for regulatory submission in this context is not explicitly mentioned.

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

• Not applicable / Not specified. See point 8.

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The Volcano s5/s5i Series Intravascular Imaging and Pressure 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 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 wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

When operating in IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees.

When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II/ComboWire) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. In conjunction with the procedure, the system measures pressure and calculates pressure differences between the aoritic pressure and the SmartWire/ComboWire pressure transducer typically located distal to the vascular lesion and calculates the fractional flow reserve (FFR).

The provided text is a 510(k) Summary for the Volcano s5/s5i Series Intravascular Imaging and Pressure System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to establish performance against acceptance criteria.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes for test and training sets, expert qualifications, or adjudication methods. The "Performance Data" section explicitly states that "A risk analysis was conducted... Applicable testing was performed as required by the Quality System to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols." This indicates that verification and validation testing was performed internally according to established quality system procedures, but the specifics of those tests and their results against quantitative acceptance criteria are not included in this summary document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing. The document mentions that "test results were found to be acceptable as required by the respective test plans and protocols," but it does not provide the specific acceptance criteria or the reported device performance measurements for any of its features (IVUS, ChromaFlo, VH IVUS, Pressure, Rotational 45MHz).

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

• Missing. The document does not describe any specific clinical or bench test sets with sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are based on substantial equivalence to predicate devices and internal verification/validation testing.

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

• Missing. No information on experts or ground truth establishment for a test set is provided.

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

• Missing. No information on adjudication methods is 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:

• Missing. This device is an imaging and pressure system, not an AI-assisted diagnostic tool in the sense of a software algorithm interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Missing. This device is a hardware system with integrated software; the concept of a "standalone algorithm" performance as typically understood for AI/CAD devices doesn't apply directly here. The system's functionalities (IVUS, pressure measurement, etc.) rely on the device hardware and software working together to produce data for human interpretation.

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

• Missing. As no specific performance study against a ground truth is described, this information is not available.

8. The sample size for the training set:

• Missing. No information about a training set is provided. The device likely uses algorithms that are well-established for intravascular ultrasound and pressure measurements, rather than machine learning models that require a distinct "training set" in the modern sense.

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

• Missing. As no training set is mentioned, the method for establishing its ground truth is also not provided.

What the document does state regarding performance evaluation:

• Performance Data: "A risk analysis was conducted according to 803475-001 Risk Management which was written to comply with ISO 14971 and IEC 60601-1-4 as specific risk management standards. Also taken into consideration in this procedure are 21 CFR 820.30 and the Medical Device Directive of the European Union (93/46/EEC). Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5/s5i Intravascular Imaging and Pressure System. The test results were found to be acceptable as required by the respective test plans and protocols."
• Conclusion: "The discussion and data presented in this 510(k) and conformance with Design Controls and the Quality System Regulations establishes the Volcano s5/s5i Series Intravascular Imaging and Pressure System to be substantially equivalent for its intended use to the predicate devices listed in this submission."

In summary, this 510(k) focuses on demonstrating substantial equivalence based on the device's technological characteristics and intended use being similar to predicate devices, and internal validation testing compliant with quality system regulations. It does not provide the specific detailed performance study information typically found in submissions for novel diagnostic algorithms or AI-driven devices.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular, Other (Specify) Intravascular

The EndoSonics Resolve option for the Oracle Imaging system is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide an alternative 2D display of ultrasound information. This additional display information is provided in addition to the standard 2D echo image. Information collected during uniform withdrawal of the imaging catheter from the artery is presented in a longitudinal display. The Resolve option also provides a computer assisted boundary detection function which helps identify boundaries within the image, which the operator must explicitly accept or correct before measurements can be performed on these boundaries.

This 510(k) summary for the EndoSonics Resolve Option for the Oracle InVision Intravascular Imaging System does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is the core requirement for 510(k) clearance.

However, based on the provided text, we can infer some aspects related to the device's function and potentially implied "acceptance criteria" through its description and comparison to predicate devices. It is crucial to understand that this is an interpretation based on limited information, and not explicit performance data.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, explicit quantitative acceptance criteria for image analysis software are rarely presented in the summary itself. Instead, the focus is on functional equivalence and safety.

Study Details (Based on the Provided Text)

Unfortunately, the provided 510(k) summary does not describe a specific scientific study with a defined test set, ground truth, or expert review process to demonstrate the performance of the "Resolve Option" software in terms of its longitudinal display or boundary detection capabilities.

The primary "study" or justification for clearance in a 510(k) is the demonstration of substantial equivalence to predicate devices. This typically involves:

1. Comparison of Indications for Use: The Resolve option is for "diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide an alternative 2D display...", which is considered equivalent to existing systems.
2. Comparison of Technological Characteristics: The software adds an "alternative 2D display" and "computer assisted boundary detection." The key argument is that the acoustic output remains unchanged.
3. Performance Data (if applicable): For software features like "computer assisted boundary detection," robust clinical performance studies might be expected in more recent submissions, but this document (1998) does not detail one. The implicit 'performance' is that the operator can accept or correct the boundaries successfully.

Given this, the following points can be addressed with the available information:

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

   • Sample Size: Not specified. There is no mention of a test set for evaluating the performance of the "Resolve Option" features (longitudinal display, boundary detection).
   • Data Provenance: Not specified. No country of origin or whether data was retrospective/prospective is mentioned, as no specific performance study is detailed.

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

   • Not applicable. No ground truth establishment process for a test set is described. The "ground truth" for the identified boundaries is ultimately the operator's explicit acceptance or correction, transforming the computer-assisted function into a user-controlled measurement tool.

3. Adjudication method for the test set:

   • Not applicable. No test set or adjudication process is described. The "adjudication" for boundary detection is the singular operator's decision to accept or correct.

4. 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. This type of study is not mentioned or described in the 510(k) summary. The "computer assisted boundary detection function" is presented as an aid that the operator validates, rather than a system designed to improve human reader performance through a comparative effectiveness study.

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

   • No. The description explicitly states the "operator must explicitly accept or correct before measurements can be performed." This indicates the device is not intended for standalone use for final measurements. Its function is to "help identify boundaries," implying an assistance role.

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

   • Not applicable for algorithm performance validation. As mentioned, for the boundary detection feature, the "ground truth" for measurement purposes is established by the operator's explicit acceptance or correction of the computer-identified boundaries. For the overall system, the ground truth for "substantial equivalence" is its clinical utility as perceived by comparison to predicate devices, rather than a specific pathological or outcomes benchmark for the added software features.

7. The sample size for the training set:

   • Not specified. As no detailed algorithmic development or validation study is provided, the training set size for the boundary detection algorithm (if it was a machine learning algorithm, which is unlikely for 1998 in this context) is unknown.

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

   • Not specified. As no training set or algorithm development details are provided, the method for establishing its ground truth is unknown.

Conclusion:

The provided 510(k) summary for the EndoSonics Resolve Option primarily serves to demonstrate substantial equivalence to existing devices for market clearance. It describes the new functional features (longitudinal display and computer-assisted boundary detection) but does not include a detailed scientific study with defined acceptance criteria, test sets, ground truth establishment, or expert reviews to quantify the performance of these features. The "acceptance criteria" are largely implicit in the claim of substantial equivalence and the design that requires operator validation for boundary detection.

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