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The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

The QUANTIEN measurement system is intended for use in the catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

The QUANTIENTTM Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWireTM guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Relevant display data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Resting Full-Cycle Ratio (RFR) index, Pd/Pa and data from ECG.

Information on the display screen may also be transferred to the cathlab monitoring system or an offsite video monitor. Recorded procedures can be viewed on a PC, with application specific viewing software installed such as RadiView, for post procedural review and analysis.

Quantien allows for importing of a patient work list from the hospital DICOM system, exporting of recorded measurement data to DICOM or to an external server location or portable (USB) memory device.

Here's a summary of the acceptance criteria and study details for the QUANTIEN™ Measurement System with Software Version 1.12.1. as presented in the provided document:

Acceptance Criteria and Device Performance

Note: The acceptance criteria are implicitly defined by demonstrating equivalence to the iFR-FFR hybrid approach, which itself serves as a benchmark for diagnostic utility in assessing coronary artery disease. The study aims to show that the RFR-FFR hybrid method performs comparably to the established iFR-FFR method.

Study Details

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

   • Sample Size: Not explicitly stated as a numerical value for the overall study. However, the results are presented with 95% confidence intervals, which usually implies a sufficient sample size was used for statistical significance.
   • Data Provenance: Prospective study. The country of origin of the data is not specified in the provided document.

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

   • The document does not specify the number of experts or their qualifications used to establish the ground truth.
   • Instead, the "ground truth" for the comparison is RFR-FFR and iFR-FFR hybrid methods, where FFR is typically considered a reference standard in fractional flow reserve studies. The document does not describe an independent "expert consensus" or manual ground truth labeling for the images/data used. The comparison is between two algorithmic approaches.

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

   • The document does not describe a specific adjudication method like 2+1 or 3+1. The study is a comparison of two physiological assessment methods (RFR-FFR vs. iFR-FFR), not a reader-based adjudication process for image interpretation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done to evaluate human reader improvement with AI assistance. This study focuses on the comparison of two physiological indices (RFR and iFR) against FFR as the reference, not on human reader performance.

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

   • Yes, the performance metrics (Diagnostic Accuracy, Agreement, PPV, NPV) presented for "RFR-FFR" and "iFR-FFR" represent the standalone performance of these hybrid methods. They involve algorithmic computation and interpretation based on defined thresholds (e.g., RFR

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OUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

The QUANTIENT™ Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Pd/Pa, and data from ECG.

Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure to aortic pressure, measured during hyperemia. It provides the maximal blood flow in the presence of a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical situation that the stenosis was not present. The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. This functionality is achieved when the QUANTIENT™ Measurement System is used in conjunction with the manufacturer's distal intracoronary pressure transducer and a proximal aortic pressure transducer.

Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure measured at resting conditions. The physician may use Pd/Pa at rest, along with knowledge of patient history, medical expertise and clinical judgment to determine if additional measurement of FFR during hyperemia or therapeutic intervention is indicated.

Information on screen can also be transferred to an external hemodynamic recording system (HRS) or to an external video monitor. Recorded procedures can be viewed on a PC for post-procedural review and analysis with application specific viewing software installed, such as RadiView™ software.

Additional functions let you import a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

This document describes the QUANTIENT™ Measurement System, a diagnostic computer designed to record, compute, display, and store data from PressureWire™ guidewire and other external transducers for the diagnosis and treatment of coronary or peripheral artery disease.

This 510(k) pertains to a Special 510(k) submission, meaning it compares a modified version of a device to an already cleared predicate device (QUANTIENT™ Measurement System, K123984). The focus is on demonstrating substantial equivalence, meaning the modified device has the same intended use and technological characteristics as the predicate, and does not raise new questions of safety and effectiveness.

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

Since this is a Special 510(k) submission for a substantially equivalent device, the performance acceptance criteria are implicitly those established for the original predicate device (K123984). The document explicitly states: "The intended use and technological characteristics of the QUANTIENT™ Measurement System that is subject to this Special 510(k) submission are the same as the predicate."

Therefore, the reported device performance for the subject device (K172182) is considered to be equivalent to the predicate device. The document does not provide a specific table of numerical acceptance criteria or performance metrics for the K172182 device itself, as the basis of this submission is equivalence to the predicate.

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

The document states: "No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." and "No new clinical testing was completed in support of this Special 510(k) submission."

Therefore, no new test set was used for this particular submission. The data provenance and sample size would refer to the testing done for the predicate device (K123984), which is not detailed in this document.

The document does mention: "Physician use and data analysis was completed and published publicly. Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication." This indicates that previous clinical data support the use of the technology, but specific details on sample size, design, and provenance related to these publications are not provided within this 510(k) summary.

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 applicable to this Special 510(k) submission as no new testing was performed and no new ground truth was established for the subject device (K172182). The ground truth would have been established during the development and clearance of the predicate device (K123984), but details are absent here.

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

Not applicable, as no new test set was used for this submission.

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

Not applicable. The device is a diagnostic computer for physiological parameters, not an AI-assisted diagnostic tool for image interpretation or similar. The document does not mention any MRMC studies or AI assistance.

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

The device itself is a standalone system that computes and displays physiological parameters. It is "algorithm only" in the sense that it performs calculations based on transducer outputs without requiring direct human interpretation of raw signals for its primary function. However, the output (FFR, Pd/Pa values) is intended to be used by a physician "along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated." Therefore, it's a standalone measurement device providing data for human interpretation, rather than an "algorithm only" diagnostic system making a definitive diagnosis without human oversight.

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

For the predicate device, the ground truth for physiological parameters (like blood pressure, FFR, Pd/Pa) would typically be established through comparison to established reference standards, often involving direct physical measurements or highly accurate invasive measurement techniques during clinical studies. The document states "Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication," implying that clinical outcomes and established clinical guidelines serve as the ultimate ground truth for the utility of these parameters. Specific details of the ground truth used for the predicate device's validation are not provided in this document.

8. The sample size for the training set

Not applicable. This is a Special 510(k) for a device that computes physiological parameters, not a machine learning or AI device that requires a distinct "training set" in the conventional sense. The device's algorithms are based on established physiological principles and measurement techniques, not on learning from a dataset.

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

Not applicable, as there isn't a training set in the context of this device's functionality. The "ground truth" for the device's calculations refers to the accuracy of its physiological measurements against accepted standards.

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QUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

QUANTIEN Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire (K113584, K080813, K062769) and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR) and data from ECG.

Information on screen can also be transferred to an external hemodynamic recording system or to an external video monitor. Recorded procedures can be viewed on a PC for review and analysis with application specific viewing software installed, such as RadiView™ software.

Additional functions allow for import of a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

The provided text describes the QUANTIEN™ Measurement System and its 510(k) submission, focusing primarily on its intended use, technical characteristics, and substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Details on experts used for ground truth establishment.
• Adjudication methods.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used (beyond implying physiological parameters).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on explaining that the QUANTIEN™ Measurement System "meets the design inputs and raises no new safety or efficacy concerns" and is "substantially equivalent to the marketed predicate device, RadiAnalyzer Xpress (K092105)." This implies that the acceptance criteria are met by demonstrating equivalence and adherence to design specifications, but the specific criteria and performance figures are not detailed.

Given the limitations of the provided text, I can only provide information based on what is available.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the QUANTIEN™ Measurement System emphasizes that the device meets its design inputs and is substantially equivalent to its predicate device, the RadiAnalyzer® Xpress (K092105). This implies that the acceptance criteria for the QUANTIEN™ system are largely based on demonstrating that it performs comparably to the predicate device in its intended function of recording, computing, displaying, and storing physiological data, including Fractional Flow Reserve (FFR), without introducing new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a specific table of acceptance criteria or reported device performance metrics for the QUANTIEN™ Measurement System. The core claim is that it "meets the design inputs" and is substantially equivalent to the predicate device.

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

The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study. The 510(k) submission primarily relies on technical characteristics, intended use, operational characteristics, and fundamental design similarities to the predicate device for demonstrating substantial equivalence.

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.

4. Adjudication method 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

The document does not describe an MRMC comparative effectiveness study nor does it mention AI assistance. The QUANTIEN™ Measurement System is described as a diagnostic computer for physiological measurements, not an AI-assisted diagnostic tool.

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

The document does not describe a standalone algorithm performance study. The device is intended to "compute and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices," implying human interaction in its use and interpretation.

7. The type of ground truth used

While not explicitly stated as "ground truth," the device's function is to "compute and display various physiological parameters." The implication is that the accuracy of these computed physiological parameters against established physiological measurement methods would serve as the ground truth for its performance. The document mentions "output from one or more electrodes, transducers or measuring devices" as the input, which suggests the ground truth would be against the direct measurements from these established sensors.

8. The sample size for the training set

The document does not specify a training set sample size.

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

The document does not provide information on how ground truth for a training set was established.

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