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OptiCross™ 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The OptiCross 18 30 MHz Peripheral Imaging Catheter is a sterile, short rail imaging catheter. It consists of two main assemblies: 1. Imaging Core and 2. Catheter Body. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 30 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end of the catheter makes the connection to the Motordrive Unit (MDU5 PLUS™) Instrument. The MDU5 PLUS-catheter interface consists of an integrated mechanical drive socket and electrical connection. The catheter body is comprised of three sections: 1. Distal Imaging Window Lumen, 2. Proximal Shaft Lumen, and 3. Telescoping Section. The distal imaging window lumen and proximal shaft lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the guiding catheter. The catheter body has a distal imaging window lumen with proximal exit at 1.6 cm from the distal end. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, two insertion depth markers are located on the proximal shaft lumen at 90 cm and 100 cm from the distal tip to aid in estimating catheter position relative to the distal guide catheter tip. The proximal shaft lumen is attached to the telescoping section via a strain relief connection. The telescoping shaft (section) allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the quidewire exit port to the proximal end of the distal imaging window lumen. The telescope section has proximal markers for lesion length assessment, consisting of a series of marks spaced 1 cm apart on the telescope body. A flush port with a one-way check valve is used to flush the interior of the catheter body and maintain a flushed condition. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way check valve helps retain saline in the catheter during use.

This document is an FDA 510(k) summary for the Boston Scientific OptiCross™ 18 Peripheral Imaging Catheter. It outlines the device's characteristics and its substantial equivalence to a predecessor device. The document explicitly states that clinical testing was not required. Therefore, it does not contain information about acceptance criteria, study methodologies, or performance statistics related to AI models, human-in-the-loop studies, or ground truth establishment.

Here's why the requested information cannot be provided from this document:

• This is a 510(k) submission for a physical medical device (an imaging catheter), not an AI/ML software device. The questions posed in the prompt (acceptance criteria for AI, sample sizes for test/training sets, ground truth establishment, MRMC studies, etc.) are relevant to the regulatory review of AI/ML-driven medical devices.
• The document explicitly states "Clinical Testing: Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross™ 18 Peripheral Imaging Catheters." This means no clinical studies were performed or submitted as part of this 510(k) process to demonstrate the device's performance in a clinical setting in the way an AI/ML device would be scrutinized.
• The "bench testing" mentioned focuses on physical integrity, functionality, and dimensional requirements of the catheter itself, not on the accuracy or performance of an imaging algorithm or interpretation.

Since the core request is to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria, and this document pertains to a physical imaging catheter that did not require clinical testing or AI/ML performance evaluation as part of its clearance, I cannot fulfill the request using the provided text.

The closest relevant information from the document would be the "Non-clinical Performance Data" section:

• Bench Testing: Performed to evaluate physical integrity, functionality, and performance.
• Performance criteria: Included imaging robustness requirements, catheter robustness requirements, dimensional requirements, and interface with compatible devices.

However, these are criteria for the physical device, not an AI model.

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