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This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The OptiCross HD and OptiCross 6 HD 60 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.

All catheters consist of two main assemblies:

1. Imaging Core
2. Catheter Body

The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 60 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
3. Telescope 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 quiding catheter.

The catheter body has a distal imaging window lumen with proximal exit at 1.6 cm from the distal end. A radiopaque (RQ) 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 quide 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.

The Coronary Imaging Catheter, 17.78 cm (7 in) extension tube, 3 cm³ (3 cc) and 10 cm³ (10 cc) syringes, and 4-way stopcock are provided in a single use sterilized package. The MDU5 PLUS Sterile Bag is provided in a separate sterile pouch within the finished carton along with the catheter package.

The provided document is an FDA 510(k) clearance letter and summary for the OptiCross™ HD Coronary Imaging Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for a new AI/imaging algorithm.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Here's why and what the document does say:

• Substantial Equivalence: The core purpose of this 510(k) submission is to show that the new OptiCross™ HD catheter is substantially equivalent to a previously cleared predicate device (OptiCross HD and OptiCross 6 HD Coronary Imaging Catheter K213593). This means the FDA determined it's as safe and effective as the predicate.
• Device Changes: The "modified device includes a protective packaging component. There are no other design changes with this 510(k)." This is a very minor change, which is why extensive new clinical studies or detailed performance metrics are not required.
• Non-Clinical Performance Data: "Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data." This bench testing evaluated "imaging quality robustness and packaging integrity." No specific performance metrics or acceptance criteria for imaging quality are provided beyond this general statement.
• Clinical Testing: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross HD and OptiCross 6 HD Coronary Imaging Catheters." This explicitly states that clinical studies (which would typically involve human readers, ground truth, etc.) were not done for this submission.

In summary, the provided document does not contain the information to answer your specific questions because it's a 510(k) clearance based on substantial equivalence for a minor device modification, not a study introducing and validating a new imaging algorithm against specific performance metrics involving human interpretation or AI.

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