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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:

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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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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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™ 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.

The provided text describes the 510(k) summary for the Boston Scientific OptiCross™ HD 60 MHz Coronary Imaging Catheter. This device is not an AI-based system. It is a physical medical device (an intravascular ultrasound catheter). Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a pre-clinical animal study, not through clinical trials or studies related to AI model performance.

However, I can extract the general acceptance criteria and the performance data for this device as detailed in the document, which primarily revolve around non-clinical bench testing and pre-clinical animal studies.

Here's a summary based on the provided text, adapted to the context of a physical medical device:

Acceptance Criteria and Device Performance (Non-AI Device)

The OptiCross™ HD 60 MHz Coronary Imaging Catheter's acceptance criteria and performance are established through non-clinical (bench) and pre-clinical (animal) testing to demonstrate substantial equivalence to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The following questions are not applicable as the device is a physical medical device and not an AI/ML-based system:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For the physical device, bench tests involve specific numbers of units for reliability and performance tests, but these are not defined as "test sets" in the same way as for AI. The pre-clinical study used a "porcine model" (pigs), but the specific number of animals is not detailed in the summary provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical imaging catheter's performance is established by direct physical measurements, engineering specifications, and physiological studies in animal models, not by expert consensus on image interpretation for AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This study focuses on the physical performance and safety of the catheter itself, not on improving human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" implicitly refers to:
* Engineering specifications and standards: For bench testing (e.g., precise dimensions, force measurements, image clarity metrics).
* Physiological measurements/observations: In the pre-clinical porcine model, direct observation and validation of imaging performance in a living system.
* Existing predicate device performance: The new device's performance is compared against the established performance of the legally marketed predicate.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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