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ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.

The ComboWire™/ComboTip™ Pressure/Flow Guide Wire is a steerable guide wire with a pressure transducer mounted less than 3 cm proximal to the tip and a tip mounted ultrasound transducer. The ComboWire/ComboTip measures pressure and flow when used with the ComboMap™ Pressure/Flow Instrument, a class IIa currently marketed device. The ComboWire/ComboTip is currently available in a diameter of 0.014" with a length of 185cm however, additional sensor configurations and wire length will be produced in the future to accommodate customer needs just as has been done with SmartWire, WaveWire and FloWire where up to 10 models are offered. The proximal end of the ComboWire/ComboTip is compatible with the provided ComboWire/ComboTip Connector Cable Assembly. The ComboWire/ComboTip can be torqued using the included torque device to facilitate navigation through the vasculature.

The provided text describes the Volcano Corporation ComboWire™ Pressure/Flow Guide Wire Family Special 510(k) submission (K042996). However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, nor does it include information typically associated with AI/ML device studies.

The document is a traditional 510(k) summary focused on demonstrating substantial equivalence to predicate devices (SmartWire® and FloWire®) for an updated medical device. The "Performance Data" section merely states: "Applicable testing was performed to evaluate the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire. The test results were found to be acceptable as required by the respective test plans and protocols." It does not elaborate on what these tests were, their acceptance criteria, or their results.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and performance studies in the context of an AI/ML device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (and why it's missing from this type of 510(k) submission):

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. This type of detail is typically not included in a 510(k) summary for a non-AI device unless significant clinical trials with human subjects are involved. The testing mentioned would likely be bench testing (e.g., pressure accuracy, flow velocity accuracy, mechanical properties, biocompatibility).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth establishment by experts is usually for diagnostic imaging or similar AI/ML applications, which is not the nature of this device.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided.
• 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: Not applicable. This is a non-AI medical device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would likely refer to calibrated measurements from reference instruments during bench testing, not clinical expert assessments.
• The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of Device and Performance Information Provided:

• Device Name: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of Products
• Intended Use: To measure simultaneous pressure and blood flow velocities in blood vessels (coronary and peripheral) during diagnostic angiography and/or interventional procedures.
• Technological Characteristics Comparison to Predicate: Combines functionality of two separate predicate wires (SmartWire® for pressure, FloWire® for flow) into one system. Material construction, measurement modalities, and instrument connections are stated to be the same as predecessor wires.
• Performance Data Statement: "Applicable testing was performed... The test results were found to be acceptable as required by the respective test plans and protocols." This is a general statement asserting compliance with internal testing protocols, but specific results are not disclosed in this summary.
• Conclusion: The device has the "same intended use and utilize the same fundamental scientific technology as that of the predicate devices. There are no new questions raised regarding safety and efficacy."

In essence, this 510(k) relies on the argument of "substantial equivalence" to previously cleared predicate devices, rather than presenting novel performance data for acceptance criteria as one would expect for an AI/ML system.

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The Volcano Therapeutics, Inc. Volcano IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano 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 Volcano Therapeutics. Inc. Volcano IVUS System is a combination of proprietary hardware and software and a phantom normalization device. The hardware portion consists of a high-speed computer, with monitor, specifically built for use in medical institutions; high-speed analog-to-digital conversion circuitry and proprietary gating circuitry. The system is connected to the output connectors of conventional IVUS systems and the ECG system using typical cabling. The IVUS radiofrequency output is used directly by the Volcano IVUS System and the ECG output is used to gate or time the collection / recording of the IVUS signal. The software that provides the user interface is Windows 2000 Professional. The Volcano IVUS System applications presently exist in two pieces. The first is the data acquisition package, IVUSLabRF. This application contains the drivers that control the Gage A/D converter card which digitizes the RF data from the IVUS console. It also manages the joining of the data from individual scans that constitute a "slice". The second software program is called IVUSLabVH. This program analyzes each of the slices. These images are visually reviewed and the control points are manually adjusted until they appear in the proper location on the vessel inner and outer borders. Once all the control points have been properly located the software produces a set of data files called "snaxel" files which define the coordinates of the control points. The black and white IVUS files and the snaxel files are loaded into the IVUSLabVH software which processes the data to produce the five color bit mapped Volcano IVUS image files. The system requires the use of a "phantom" to "normalize" the conventional IVUS output. The phantom is a small piece of acrylic material machined to allow placement over the IVUS catheter distal tip.

The provided 510(k) summary for the Volcano IVUS System (K042188) does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the way typically expected for an AI/ML device.

Instead, this submission primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with general quality and safety standards.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will explain why each section cannot be populated directly and provide what information is available.

1. Table of Acceptance Criteria and Reported Device Performance

Information within the document: The document states, "Additionally, testing and validation exercises have produced results consistent with design input requirements." However, the design input requirements themselves, which would define the acceptance criteria and specific performance metrics, are not disclosed in this summary. No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, dice coefficient, etc.) are reported for features like semi-automatic boundary visualization or spectral analysis.

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

Information within the document: The document mentions "testing and validation exercises," but it does not specify any sample size for a test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature).

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.

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

Information within the document: The summary does not mention any expert-led ground truth establishment process for the performance testing. The "semi-automatic border detection" description implies user interaction ("control points are manually adjusted"), but this is part of the device's operational workflow, not necessarily a ground truth adjudication process for performance evaluation.

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Information within the document: As no specific test set and ground truth establishment is described, an adjudication method is also not mentioned.

• Adjudication Method: Not specified.

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

Information within the document: There is no indication that an MRMC comparative effectiveness study was conducted or reported in this 510(k) summary. The focus is on demonstrating substantial equivalence to predicate devices, not on quantifying human performance improvement with or without AI assistance.

• MRMC Study Conducted: No.
• Effect Size (human readers with/without AI): Not applicable, as no such study was reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Information within the document: The device description clearly states, "These images are visually reviewed and the control points are manually adjusted until they appear in the proper location on the vessel inner and outer borders." This indicates it is a "semi-automatic" system, meaning it requires human-in-the-loop interaction for its primary function of boundary detection. Therefore, a standalone (algorithm only) performance would not be representative of its intended use and is not reported.

• Standalone Performance Study: Not reported, and the device's nature suggests it's designed for human-in-the-loop operation.

7. The Type of Ground Truth Used

Information within the document: The summary does not specify the type of ground truth used for performance evaluation. Given the context of IVUS imaging, potential ground truth types could include expert consensus on images, comparison to other imaging modalities or histology (though less common for real-time IVUS validation in this context). However, none are explicitly stated. The "manual adjustment of control points" refers to the user interaction with the device, not the ground truth for an independent test.

• Type of Ground Truth: Not specified.

8. The Sample Size for the Training Set

Information within the document: The document does not mention any training set or its sample size. This 510(k) submission predates the common requirements for detailed AI/ML model training data specifics.

• Sample Size for Training Set: Not specified.

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

Information within the document: As no training set is mentioned (see point 8), the method for establishing its ground truth is also not described.

• How Ground Truth for Training Set Was Established: Not specified.

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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.

The ComboMap™ Pressure and Flow System is a computer-controlled (PCbased) instrument, which processes the information it receives from the transducer mounted in a Volcano Therapeutics SmartWire" Pressure Guide Wire, Volcano Therapeutics FloWire® Doppler Guide Wire, 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 SmartWire® pressure, and a calculated parameter, such as gradient or fractional flow reserve (FR), and one of six (6) selected waveforms. The ComboMap™ also supplies an analog output of the SmartWire® pressure for display on a conventional physiologic monitoring svstem.

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.

Depending on the clinicians' preference, the physician has the option of using a pressure guide wire (SmartWire®), a flow guide wire (FloWire®) or both. By using these guide wires from Volcano Therapeutics, the physician can measure pressure and/or flow velocity.

The provided document does not contain enough information to fully describe the acceptance criteria and the study that proves the device meets those criteria in the requested format.

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

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

The document states: "Applicable testing was performed to evaluate the ComboMap™ Pressure and Flow System. The test results were found to be acceptable as required by the respective test plans and protocols."

This indicates that acceptance criteria and performance data exist, but they are not provided in this summary. The summary only confirms that the device passed its internal testing.

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.

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 in the document. The device appears to be a measurement system, not one that requires human expert interpretation for ground truth, but the details of its validation are missing.

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

This information is not provided in the document.

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

This is not applicable. The ComboMap™ Pressure and Flow System is a device for measuring physiological parameters (blood pressure and flow velocity), not an AI-powered diagnostic tool that assists human readers.

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

This is not applicable in the context of "algorithm only." The ComboMap™ is a standalone system that performs measurements. Its performance would be evaluated on the accuracy and precision of its measurements against a reference standard, not against a "human-in-the-loop" scenario in the way an AI diagnostic tool would be. The document implies standalone performance testing was done, but no details are provided.

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

The document does not explicitly state the "type of ground truth." For a measurement device like this, the ground truth would typically be established by highly accurate reference measurement methods (e.g., calibrated pressure transducers, flow meters) in a controlled environment. However, the details of these reference methods are not provided.

8. The sample size for the training set

This is not applicable. This device is a measurement system, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

Summary of Available Information:

The document describes the ComboMap™ Pressure and Flow System as a multi-mode system combining the functionality of previous separate pressure and flow measurement devices (SmartMap®, WaveMap®, and FloMap®). It's intended to measure intravascular blood pressure and/or blood flow velocities.

The "Performance Data" section briefly states that "Applicable testing was performed to evaluate the ComboMap™ Pressure and Flow System. The test results were found to be acceptable as required by the respective test plans and protocols." This indicates that internal testing was conducted against pre-defined acceptance criteria, and the device passed. However, the specifics of those criteria and the detailed performance results are not included in this 510(k) summary.

The 510(k) process in this case relies on demonstrating substantial equivalence to predicate devices (SmartMap® Pressure System, WaveMap® Pressure System, FloMap® Doppler Flow System). The key argument is that "Signal processing, measurement modalities and instrument connections are the same as the predecessor instruments. The intended use and the fundamental scientific technology of the SmartMap® WaveMap® and FloMap have not been altered but are combined together in the ComboMap™." This implies that the performance characteristics were expected to be similar due to the use of established technologies.

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