(123 days)
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.
| Metric (vs FFR) | Acceptance Criteria (Implicit: Comparable to iFR-FFR) | Reported Device Performance (RFR-FFR) |
|---|---|---|
| Diagnostic Accuracy | Comparable to 92.2% [89.5%, 94.4%] | 93.6% [91.1%, 95.6%] |
| Percent Positive Agreement | Comparable to 88.8% [84.1%, 92.5%] | 91.3% [86.9%, 94.5%] |
| Percent Negative Agreement | Comparable to 95.4% [92.1%, 97.6%] | 95.8% [92.6%, 97.9%] |
| Positive Predictive Value (PPV) | Comparable to 94.7% [90.9%, 97.2%] | 95.2% [91.6%, 97.6%] |
| Negative Predictive Value (NPV) | Comparable to 90.2% [86.1%, 93.5%] | 92.3% [88.4%, 95.1%] |
| Diagnostic Accuracy Outside the Grey Zone | Comparable to 86.8% [82.4%, 90.4%] | 88.5% [84.1%, 92.0%] |
| Lesions free from Hyperemic Agents | Comparable to 58.9% [54.4%, 63.2%] | 55.5% [51.0%, 59.9%] |
| Patients free from Hyperemic Agents | Comparable to 54.3% [49.5%, 59.1%] | 50.8% [46.0%, 55.6%] |
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.