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The Reconnaissance PV .018 Digital IVUS catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicted for use in cerebral vessels.

The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reconnaissance PV .018 OTW IVUS Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end and has a transducer that utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The catheter has 150cm working length and a hydrophilic coating at the distal 40 cm to assist the clinician in advancing the catheter to the desired location. The minimum guide sheath is 5F (0.074") and the maximum guide wire Outer Diameter (OD) is 0.018" (0.46 mm).

At the proximal end, there is a PIM Connector and Y Connector (aka Y-Arm). The Y-Arm allows the catheter to incorporate the PIM Connector while still serving as an over-the-wire design. A Luer/hub fitting (aka the Y-Arm) is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the scanner lead wires, routed from the cylindrical ultrasound transducer array, to interface electrically with the patient interface module (PIM) connector. The Visions® PV 0.018 Catheter may only be used with Philips Imaging Systems, such as the CORE Series Precision Guided Therapy Systems such as the IntraSight System.

I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific performance criteria. The text describes the product, its indications for use, and a comparison to predicate devices, but lacks the specific data points needed to answer your questions.

Here's what I can tell you based on the provided text, and what is missing:

Missing Information:

• Detailed Acceptance Criteria and Reported Device Performance Table: The document states "Based on the testing results, the Reconnaissance Digital IVUS Catheter is substantially equivalent to the predicates. The data support the performance and safety of the device. Verification/validation demonstrate that the Reconnaissance catheter will perform as intended in the defined conditions." However, it does not provide a table outlining specific acceptance criteria (e.g., image resolution, penetration depth, signal-to-noise ratio) and the corresponding reported performance values for the Reconnaissance PV .018 OTW Digital IVUS Catheter.
• Sample Size for Test Set and Data Provenance: This information is not explicitly stated.
• Number of Experts and Qualifications for Ground Truth of Test Set: This information is not provided.
• Adjudication Method for Test Set: This information is not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of an MRMC study or any comparison of human reader performance with and without AI assistance.
• Standalone Performance Study: The document does not explicitly detail a standalone performance study of the algorithm without human-in-the-loop.
• Type of Ground Truth Used: The document mentions "testing results" and "verification/validation" but does not specify the type of ground truth used (e.g., another imaging modality, histological analysis, clinical outcomes).
• Sample Size for Training Set: This information is not provided.
• How Ground Truth for Training Set was Established: This information is not provided.

The document primarily focuses on the regulatory submission (510(k)) and establishing substantial equivalence to existing predicate devices based on design, indications for use, and principle of operation, rather than providing a detailed technical performance study in this summary. It mentions that "Verification/validation demonstrate that the Reconnaissance catheter will perform as intended," implying that studies were conducted, but the specifics are not included in this document.

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