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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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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.

OptiCross™ 18 is a short-rail 30 MHz IVUS imaging catheter. It is compatible with a 0.018" guidewire, and at a minimum, a 6F guide catheter (≥ 0.068" ID). OptiCross 18 is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and BSC's latest motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic examination of peripheral intravascular pathology. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal quidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter. The distal quidewire lumen (1.6 cm in length) is used to track the catheter along the quidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm). The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The drive cable and PZT transducer rotate independently of the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to 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 visualization.

Here's a breakdown of the acceptance criteria and the study information for the OptiCross 18 30 MHz Peripheral Imaging Catheter, based on the provided document:

This document describes a 510(k) submission for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed here relate to non-clinical performance and safety metrics, rather than a clinical trial's primary and secondary endpoints often seen with novel device submissions. The "study" refers to a series of non-clinical evaluations and a pre-clinical animal study.

1. Table of Acceptance Criteria and Reported Device Performance

The document details numerous performance criteria and states that bench testing was performed to evaluate them. However, it does not provide specific numerical acceptance criteria or quantitative performance results for each individual parameter. Instead, it makes a general statement that "Bench testing was performed... Performance criteria includes deliverability, crossability, guide catheter compatibility, lubricity, retraction capability, image resolution, image penetration, non-uniform rotational distortion (NURD), measurement accuracy, pullback reliability, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness and simulated use structural integrity." The conclusion for all these tests is that they support substantial equivalence.

Therefore, a table with specific numerical values cannot be created from this document. The reported device performance is that it met the unspecified criteria for each test, demonstrating substantial equivalence to the predicate device.

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

• Bench Testing: The document does not specify the sample sizes used for each of the bench tests (e.g., how many catheters were tested for deliverability, image resolution, etc.).
• Pre-clinical Evaluation (Animal Study): The document states this study was done "in the porcine model." It does not specify the number of animals (sample size) used in this pre-clinical study.
• Data Provenance:
  • Bench Testing: Conducted in a lab setting. The country of origin is not explicitly stated but can be inferred to be within the US, given the submission to the FDA by Boston Scientific Corporation, Fremont, CA. This is a retrospective analysis of device performance against internal specifications.
  • Pre-clinical Evaluation: In vivo animal study. Country of origin not specified, but likely US-based given the submitter. This is a prospective study (for the animal model).

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

• Bench Testing: Not applicable in the context of expert-established ground truth. These tests would involve objective measurements and comparisons to engineering specifications.
• Pre-clinical Evaluation (Animal Study): The document does not specify the number of experts or their qualifications involved in evaluating the in-vivo image quality from the porcine model. Image quality assessment would typically involve trained personnel, potentially veterinarians or scientists with expertise in imaging interpretation.

4. Adjudication Method for the Test Set

• Given that the primary evidence cited is non-clinical bench testing and a pre-clinical animal study, adjudication methods like 2+1 or 3+1 (common in clinical image review) are not applicable or described in this context. These tests rely on objective physical measurements and established protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data." Therefore, there is no information on how human readers improve with or without AI assistance. This device is purely an imaging catheter, not an AI-driven interpretive device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Yes, in a functional sense, this is a standalone device. The "performance" described (image quality, deliverability, etc.) refers to the device's inherent capabilities without human interpretation influencing its mechanical or imaging production efficacy. The device's ability to produce images (image resolution, penetration, NURD) is evaluated on its own. It's a diagnostic tool that produces imaging data, not an AI algorithm performing interpretation.

7. Type of Ground Truth Used

• Bench Testing: Engineering specifications, physical measurements, and established testing protocols serve as the "ground truth" to determine if the device performs as intended and meets design requirements.
• Pre-clinical Evaluation: The "ground truth" for evaluating image quality in the porcine model would be the actual anatomical structures and pathologies within the animal, as observed or confirmed by other means (e.g., histology post-mortem, comparison to established imaging standards for IVUS in animals). The purpose was to "support acute performance and design validation claims associated with in-vivo image quality."

8. Sample Size for the Training Set

• Not applicable. This document describes a medical device undergoing 510(k) clearance based on substantial equivalence, primarily through non-clinical testing and a pre-clinical animal study. It is not an AI/ML-based device that requires a "training set" in the computational sense. The device itself is the product.

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

• Not applicable. As stated above, this is not an AI/ML device that uses a "training set."

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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™ X is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 5F guide catheter (≥ 0.058" ID). OptiCross X is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and BSC's latest motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic examination of coronary intravascular pathology. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal quidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter. The distal quidewire lumen (1.6 cm) is used to track the catheter along the quidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm). The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The drive cable and PZT transducer rotate independently of the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to 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 visualization.

The provided text describes a 510(k) premarket notification for the OptiCross™ X, 40 MHz Coronary Imaging Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. Therefore, the information provided focuses on non-clinical performance evaluations and comparisons to the predicate device.

Based on the provided document, the following points regarding acceptance criteria and study information can be extracted:

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

The document lists "Performance criteria" for bench testing but does not provide a quantitative table of specific acceptance limits alongside the achieved device performance. Instead, it states that "Bench testing was performed to evaluate physical integrity, functionality, and overall performance of the catheter" and lists the categories of performance criteria evaluated.

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

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of catheters tested) for each non-clinical performance evaluation. It broadly states "Bench testing was performed."
• Data Provenance: The data is from non-clinical (bench-top) performance evaluations, packaging validation, biological safety, electromagnetic compatibility, and acoustic output testing. The geographic origin of this testing is not specified, but it would typically be conducted by the manufacturer (Boston Scientific Corporation, Fremont, California) or their designated testing labs. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.

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

This information is not applicable as the evaluation for this 510(k) relies on non-clinical (bench) testing, not human interpretation of medical images or expert consensus on a test set. Therefore, there is no "ground truth" derived from expert review in the context of this submission.

4. Adjudication method for the test set:

Not applicable. As there is no "test set" in the context of human interpretation of medical images, there is no adjudication method described.

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 device is an imaging catheter and is not an AI-powered diagnostic tool requiring MRMC studies to evaluate human reader performance with or without AI assistance. The submission is based on demonstrating substantial equivalence through non-clinical performance data.

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

Not applicable. This is a hardware device (catheter) used for intravascular ultrasound imaging, not a standalone algorithm. Its performance is evaluated through its physical and imaging capabilities as part of a system (catheter + MDU + iLab equipment), not as an algorithm performing a diagnostic task independently.

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

For the non-clinical performance evaluations, the "ground truth" is defined by engineering specifications, material standards, and regulatory limits. For example, the "acoustic output" ground truth is defined by FDA Guidance limits, "biological safety" by ISO 10993-1 standards, and "electromagnetic compatibility" by IEC 60601-1-2. For physical performance characteristics like dimensions, deliverability, or image quality, the ground truth is established by the device's design specifications and the performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a hardware device submission; there isn't a "training set" in the machine learning sense. The device design and manufacturing processes are developed based on engineering principles and existing knowledge, not through a "training set" of data.

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

Not applicable. As there is no "training set" for a hardware device, there is no ground truth established for it in this context. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and regulatory standards.

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