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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.

OptiCross™ 6 HD (60 MHz Coronary Imaging Catheters) is a sterile, short rail imaging catheter. It consists 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™). 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. 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 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 guidewire 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OptiCross™ 6 HD, 60 MHz Coronary Imaging Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not present a single, consolidated table of specific quantitative acceptance criteria alongside corresponding quantitative device performance metrics for all aspects of the device. Instead, it describes various tests performed and states that the device met the requirements or was "substantially equivalent" to the predicate.

However, based on the narrative, we can infer some criteria and the general statement of performance:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size for the bench testing. For the pre-clinical animal study, it mentions performing the study "in the porcine model," implying a certain number of animals were used, but the exact count is not given.
• Data Provenance: The studies were prospective as they were conducted to validate the new device. The data provenance can be inferred as primarily in-house testing by Boston Scientific Corporation, supplemented by a porcine animal model for pre-clinical evaluation. No information on data origin by country is provided, but it's reasonable to assume the testing occurred within the company's facilities or contracted labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the test set. For the in-vivo animal study, it states the purpose was "to support design validation and business need evaluations claims associated with in-vivo image quality," but it doesn't describe an explicit process of expert review for ground truth. Given the nature of the device (coronary imaging catheter), experts would likely be interventional cardiologists or veterinarians specializing in animal models.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the test set results, particularly for image quality assessment. The studies conducted are primarily non-clinical and bench-top evaluations, which typically rely on predefined measurement protocols and direct comparison to specifications rather than expert consensus adjudication.

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

There was no MRMC comparative effectiveness study done, and the document explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data." This device does not involve AI assistance, so any effect size related to AI improvement is irrelevant.

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

This refers to a medical device that autonomously performs a task without direct human intervention or interpretation. The OptiCross™ 6 HD is an imaging catheter, meaning it provides images that a human (physician) then interprets. Therefore, a standalone performance assessment in the context of an algorithm without human-in-the-loop performance is not applicable to this device. Its performance is evaluated by the quality of the images it produces for human interpretation and its physical/functional characteristics.

7. The Type of Ground Truth Used

• For bench testing, the ground truth would be against engineering specifications, calibrated measurement tools, and physical standards (e.g., precise dimensions, known material properties, pre-defined performance limits).
• For the pre-clinical animal study, the "ground truth" for in-vivo image quality would be the actual anatomical structures and pathologies within the porcine coronary arteries, visually confirmed by the imaging system itself and potentially correlated with gross pathology or histology post-mortem if such detailed validation was performed (though not explicitly stated in the summary).

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware device (catheter) that produces images. Therefore, the concept of a "training set" as used for AI models is not applicable.

9. How the Ground Truth for the Training Set was Established

As explained above, there is no training set for this type of hardware medical device.

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