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The OptiCross 35 15 MHz Peripheral Imaging Catheter is intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

OptiCross 35 15 MHz Peripheral Imaging Catheter (OptiCross 35) is designed for use with BSC's iLab™ Ultrasound Imaging System equipment and the motor drive unit, MDU5 PLUS™. When used together, the catheter, the motor drive unit, and iLab System equipment form a complete imaging system that allows for ultrasonic visualization of the peripheral vasculature.

OptiCross 35 consists of two main components: the telescoping section and the dual lumen sheath.

The telescoping section remains exterior to the patient's body during use and allows the imaging core to be advanced and retracted over 25cm of linear movement.

The dual lumen sheath has one lumen which surrounds the imaging core attached proximally to the hub, and the other lumen is for guidewire use.

The imaging core is composed of a high-torque, flexible, rotating drive cable with an outward-looking ultrasonic transducer at the distal tip. The proximal hub provides an electro-mechanical interface between the catheter and the motor drive unit. There are 25 radiopaque gold markers, approximately 1 cm apart, beginning at the distal end of the imaging core, which ends with a radiopaque housing that contains the transducer. Heparinized saline is flushed within the catheter prior to use to act as an acoustic medium.

The PZT transducer and the drive cable rotate independently from the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive into transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for live visualization of intravascular structures.

The provided document is a 510(k) premarket notification for the Boston Scientific OptiCross 35 15 MHz Peripheral Imaging Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, biological safety, electrical and mechanical safety, packaging validation), rather than presenting a study proving a device meets specific acceptance criteria for an AI or imaging diagnostic performance claim.

Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies) are not applicable to this submission as they would typically be found in documentation for devices with more complex diagnostic algorithms or AI components.

However, I can extract the relevant information regarding the performance claims and the testing conducted:

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

The document does not present explicit "acceptance criteria" in a quantitative, diagnostic performance sense (e.g., sensitivity, specificity, accuracy for a clinical outcome). Instead, its acceptance is based on demonstrating substantial equivalence to a predicate device through a series of engineering and safety tests. The "performance criteria" listed are related to the physical and functional integrity of the catheter rather than diagnostic accuracy.

Here's a summary of the non-clinical performance data and what was evaluated:

• Deliverability
• Guidewire and sheath compatibility
• Image quality
• Non-uniform rotational distortion
• Measurement accuracy
• General imaging capabilities
• Dimensional requirements
• Catheter tensile strengths
• Freedom from leak
• Visibility under fluoroscopy
• Interface with ancillary devices
• Environmental requirements
• User interface requirements
• Corrosion resistance
• Particulates |
  | Biological Safety Testing | Device is biocompatible for its intended use.
• Compliance with ISO 10993-1
• Microbial assessments (bioburden, endotoxin)
• Pyrogenicity and sterility assurance testing |
  | Electrical and Mechanical Safety |
• Acoustic Output: Below FDA Track 1 limits (tested per FDA Guidance, June 27, 2019).
• Electromagnetic Compatibility (EMC): Compliance to IEC 60601-1-2 (4th Ed.) and IEC 60601-2-37 (Ed. 2.1). |
  | Packaging Validation | Integrity of packaging configuration evaluated and maintained after electron beam sterilization, climatic conditioning, and distribution challenge conditioning (in accordance with ISO 11607-1 and ISO 11607-2). |

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

The document does not describe a "test set" in the context of a clinical performance study (e.g., patient data for diagnostic accuracy). The testing described is primarily bench-top and laboratory testing of the device itself.

• Sample Size for Bench Testing: Not explicitly stated but implied to be sufficient for engineering validation.
• Data Provenance: The studies are non-clinical, performed in a laboratory setting. No geographical origin of patient data or retrospective/prospective nature is applicable as no patient data was used for performance validation.

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

Not applicable. Ground truth as typically defined for diagnostic AI/imaging devices (e.g., expert reads of images, pathology results) was not established because no clinical performance study involving human interpretation of images was conducted. The "ground truth" here is adherence to engineering specifications and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no human expert adjudication of diagnostic outputs occurred.

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

Not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device, and its clearance is based on substantial equivalence to a predicate, not an improvement in human reader performance.

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

Not applicable. This is not an algorithmic device in the sense of AI or automated measurement. Its function is to acquire intravascular ultrasound images for human interpretation. The "performance" measured here relates to the quality of the image acquisition and the physical properties of the catheter.

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

The "ground truth" for this device's performance is adherence to established engineering, safety, and imaging quality standards for an ultrasound transducer, not clinical ground truth (e.g., disease presence). For example:

• Acoustic output "ground truth" is established by regulatory limits (FDA Track 1 limits).
• Biocompatibility "ground truth" is established by ISO 10993-1.
• Image quality, measurement accuracy, and other functional aspects are assessed against internal specifications determined by the manufacturer, likely based on industry standards and performance of the predicate device.

8. The sample size for the training set

Not applicable. This device does not have a "training set" as it is not an AI/machine learning device.

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

Not applicable. This device does not have a "training set."

In summary: The provided document is a 510(k) summary for a medical device (an intravascular ultrasound catheter) based on substantial equivalence. It highlights non-clinical bench, safety, and integrity testing rather than a clinical performance study evaluating diagnostic accuracy or AI performance. Therefore, many of the questions related to AI-specific study designs, expert involvement, and ground truth establishment from clinical data are not addressed by this type of regulatory submission.

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