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The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal procedures. The compatible Dragonfly™ imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

OPTISTM with AptiVueTM Software (version E.5) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFR physiological waveforms measured by the system are used to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure).

Here's an analysis of the acceptance criteria and study information for the ILUMIEN OPTIS with AptiVue Software version E.5, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the validation of the Resting Full-cycle Ratio (RFR) feature, comparing its diagnostic performance against Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR). The acceptance criteria are implicitly defined by achieving comparable diagnostic accuracy and agreement metrics.

2. Sample Size and Data Provenance:

The document does not explicitly state the exact sample size for the test set. However, it refers to a "prospective study... of RFR for the physiological assessment of coronary artery disease in real-world patients." The confidence intervals provided in the table, such as "91.1%, 95.6%" for diagnostic accuracy, indicate a substantial number of cases. Given the context of a 510(k) summary, specific details on country of origin are typically not provided, but the language suggests a clinical trial setting. The study was prospective.

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish the ground truth for the test set, nor their qualifications.

4. Adjudication Method:

The document does not explicitly describe an adjudication method for the test set. It outlines a "RFR-FFR Hybrid Method Result Interpretation" which includes a grey zone where the decision would be "based on FFR." This implies FFR serves as the primary ground truth, and the RFR values are being compared against it.

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

No MRMC study is mentioned. The document focuses on the performance of the RFR algorithm itself compared to established physiological indices (FFR and iFR). There is no information provided regarding the effect size of human readers improving with AI assistance vs. without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done. The "Summary of RFR Validation Study" directly compares the diagnostic accuracy and agreement metrics of the RFR algorithm (standalone, or hybrid with FFR for the grey zone) against FFR as the gold standard, and against iFR-FFR for equivalence.

7. Type of Ground Truth Used:

The ground truth used is primarily Fractional Flow Reserve (FFR). For the RFR-FFR hybrid method, when RFR falls within a defined grey zone (0.86 ≤ RFR ≤ 0.93), the decision is explicitly stated to be "based on FFR." Therefore, FFR serves as the reference standard for determining ischemia-causing lesions.

8. Sample Size for the Training Set:

The document does not provide information about the sample size for the training set used to develop the AptiVue Software.

9. How the Ground Truth for the Training Set was Established:

The document does not provide information on how the ground truth for the training set was established. It describes the validation study of the RFR feature, not the development process of the software.

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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 < 0.86 for positive, FFR ≤ 0.8 for positive). There isn't a human-in-the-loop element described in these performance metrics.

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

   • The "ground truth" or reference standard used in this comparative study is Fractional Flow Reserve (FFR), which is a widely accepted physiological measure for assessing the hemodynamic significance of coronary artery stenoses. The study compares the RFR-FFR and iFR-FFR hybrid approaches against this standard.

7. The sample size for the training set:

   • The document states, "No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k)." This implies that the RFR algorithm and its established thresholds were likely developed and validated prior to this submission, possibly through other studies. Therefore, the training set size is not provided in this document as it pertains to development data that was not newly generated for this submission.

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

   • Given the statement in point 7, the document does not describe how the ground truth for any training set was established for the RFR algorithm. The presented clinical testing is a validation study of the already established RFR method, not a development study.

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