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The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The C7 XR™ Imaging System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). 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.

The C7 XR™ Imaging System K093857 (C7 XR) and Dragonfly™ Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real-time images. The C7 XR will include two USB receivers to accept radiofrequency signals from a distal intracoronary pressure transducer and a proximal aortic pressure transducer and display the acquired pressure waveforms and calculated Fractional Flow Reserve on the C7 XR system monitor.

The C7 with FFR system consists of the following components:

C7 XR Imaging System (K093857): A cart-mounted computer and optical engine control the device and function as user interface, display and data storage. It includes the Drive-motor and Optical Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 XR and Dragonfly Catheter, and controls the rotational and axial motion of the fiber-optic core within the catheter and will include two USB receivers to accept radiofrequency signals from the distal intracoronary pressure transducer and a proximal aortic pressure transducer.

The provided text describes a 510(k) submission for the C7 XR™ Imaging System with Fractional Flow Reserve (FFR) and primarily focuses on its substantial equivalence to predicate devices and adherence to various standards. While it mentions "Clinical performance evaluation (Usability Testing)" for equivalence, it does not provide detailed information about specific acceptance criteria for system performance regarding FFR calculations or a study proving those criteria are met.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Qualifications of those experts.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone (algorithm only) performance study details.
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The text is a regulatory submission for a device modification, focusing on safety, effectiveness, and substantial equivalence, not a detailed clinical performance study report.

Information Extracted from the Text (as relevant to the request, even if it highlights missing information):

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics for FFR accuracy or any other quantitative measure. The submission relies on "Usability Testing" and compliance with standards for substantial equivalence.
• Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or numerical concordance for FFR values) are reported in this summary.

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

• Sample Size: Not specified. The clinical performance evaluation is referred to as "Usability Testing," which typically focuses on user interaction rather than extensive FFR accuracy testing against a gold standard.
• Data Provenance: Not specified.

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

• Not specified.

4. Adjudication method 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 MRMC study is mentioned. The device provides "Fractional Flow Reserve (FFR)" which is a physiological parameter calculated from pressure transducers, not an AI interpretation of images requiring human reader comparative effectiveness. The text indicates that "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," implying FFR (the output of the device) is an input to human clinical judgment, rather than the device assisting human readers in interpreting complex images directly.

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

• The device calculates FFR based on pressure transducer signals and displays it. It is inherently a "standalone" calculation, as it's an automated measurement. However, there are no reported performance metrics for this calculation within this document. The FFR calculation itself is well-established in cardiology. The submission focuses on the incorporation of this functionality into the C7 XR system and its equivalence to predicate FFR devices (RadiAnalyzer® Xpress and Pressure Wire®).

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

• Not specified. For FFR, the ground truth would typically be the measurement itself using an established reference method, but no such comparison data is presented. The "Usability Testing" mentioned would not typically establish this kind of ground truth.

8. The sample size for the training set

• Not applicable, as this is a device incorporating a known physiological measurement technique (FFR) and not a machine learning algorithm requiring a training set in the conventional sense. The "algorithm" for FFR calculation is based on principles of fluid dynamics.

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

• Not applicable (see point 8).

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