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The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for patients with vascular occlusive disease for which angioplasty, atherectomy, the placement of stents, or other intervention is contemplated.

Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for use with the Boston Scientific iLab™ equipment and 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 visualization of peripheral intravascular structures.

The catheter consists of two main components: the catheter body and the imaging core.

The catheter body consists of three sections: the braided proximal shaft, single lumen mid-shaft, and the sonolucent distal tip. The catheter body comprises the usable length of the catheter (110 cm).

The braided proximal shaft provides the pushability to the catheter and serves as a lumen to the imaging core. The mid-shaft provides a flexible transition between the stiffer proximal shaft and the acoustically transparent distal tip. The distal tip serves as the imaging window and houses a septum situated between the inner lumen and the atraumatic rounded tip of the catheter. The self-sealing septum serves as the distal-flush entry point, as the catheter is flushed with water prior to use. This provides the acoustic coupling media required for ultrasonic imaging.
The imaging core consists of a proximal hub assembly, a rotating drive cable, and a radiopaque tip. The hub assembly provides an electro-mechanical interface between the catheter and the motor drive unit. The drive cable houses the low frequency piezoelectric (PZT) transducer at the distal imaging window.
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 text is a 510(k) summary for the Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter. It outlines the device's characteristics, intended use, and substantial equivalence to a predicate device based on non-clinical performance data. Since this is a submission for a medical device that relies on physical characteristics and performance rather than an AI/ML algorithm that predicts or classifies, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific numerical acceptance criteria in a table format, nor does it present specific numerical performance results against those criteria. Instead, it describes general performance categories tested. The primary "acceptance criterion" is demonstrating substantial equivalence to the predicate device.

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

The document describes non-clinical bench testing. It does not specify a "test set" in terms of patient data. The "samples" would be the catheters themselves. The exact number of catheters used for each type of bench test (e.g., how many were fatigue tested, how many were dimensionally checked) is not provided.

• Sample size for test set: Not specified (refers to physical devices, not patient data).
• Data provenance: Not applicable as it's non-clinical bench testing.

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

Not applicable. This is a physical medical device (intravascular ultrasound catheter) where performance is measured using engineering and biological standards, not expert interpretation of images or data to establish a ground truth for an AI/ML algorithm.

4. Adjudication Method for the Test Set:

Not applicable, as it's non-clinical bench testing of a physical device.

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 is not an AI/ML device, and no MRMC study was performed or required. The submission explicitly states "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, "ground truth" refers to established engineering specifications, regulatory standards (e.g., ISO, FDA guidance), and physical measurements. For example:

• Dimensional requirements: Engineering specifications for length, diameter, etc.
• Biocompatibility: ISO 10993-1 standards.
• Acoustic Output: FDA guidance for diagnostic ultrasound systems.
• Sterility: Sterility assurance level (SAL).
• Electrical/Mechanical Safety: IEC 60601-1-2.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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The Ultra ICE Plus rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.

Ultra ICE Plus is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and 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 visualization of intracardiac structures. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of three sections: the braided proximal shaft, single lumen mid-shaft, and the sonolucent distal tip. The catheter body comprises the usable length of the catheter (110 cm). The braided proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. The mid-shaft provides a flexible transition between the stiffer proximal shaft and the acoustically transparent distal tip. The distal tip serves as the imaging window and houses a septum situated between the inner lumen and the atraumatic rounded tip of the catheter. The self-sealing septum serves as the distal-flush entry point; as the catheter must be flushed with water prior to use. This provides the acoustic coupling media required for ultrasonic imaging. The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a low frequency piezoelectric (PZT) transducer at the distal imaging window. The hub assembly provides an electro-mechanical interface between the catheter and the motor drive unit. 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 live visualization of intracardiac structures.

This document is a 510(k) summary for the Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than outlining a study to prove the device meets specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding clinical studies and ground truth cannot be extracted directly from this document.

However, I can extract the acceptance criteria and the type of studies conducted for non-clinical performance, as well as what the document reports about the device's performance against these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Successfully met evaluation conditions": The document states for bench testing, biological safety, and packaging validation that "Non-clinical performance evaluations, as described above, indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device (Ultra ICE, K902245)." This implies that the device performed acceptably against the established criteria for each of these tests.

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

• Test Set (Non-clinical): Specific sample sizes for each non-clinical test (e.g., number of catheters tested for fatigue, number of units for packaging validation) are not provided in this summary.
• Data Provenance: The studies were non-clinical bench, lab, and engineering tests conducted by the manufacturer (Boston Scientific Corporation). There is no mention of country of origin of data in terms of patient data, as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• This information is not applicable as the studies described are non-clinical (bench testing, biocompatibility, electrical/mechanical safety, packaging validation). No human experts were used to establish ground truth in the context of diagnostic performance or clinical outcomes for these tests.

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

• This information is not applicable as the studies described are non-clinical tests. Adjudication methods are typically used in clinical studies.

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:

• No, an MRMC comparative effectiveness study was not stated as part of this submission. The submission explicitly states "Clinical Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data." This device is an imaging catheter itself, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm-only performance study was not stated as part of this submission. This device is an imaging catheter.

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

• For the non-clinical tests, the "ground truth" was based on engineering specifications, regulatory standards (e.g., ISO, IEC, FDA guidance), and established scientific methods for evaluating device performance, safety, and compatibility. For example, acoustic output limits are defined by FDA guidance, and biocompatibility by ISO 10993-1.

8. The sample size for the training set:

• This information is not applicable. This is a submission for a medical device (catheter), not an AI algorithm requiring a training set.

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

• This information is not applicable. This is a submission for a medical device (catheter), not an AI algorithm requiring a training set.

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In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also incicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vaculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The JOMED Inc. In-Vision™ Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intra'uminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the In-Vision™ Imaging Systems can be adjunct to interventional therapies, such as balloon angioplasty. With ChromoFloTM, a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing a ditional information for vessel analysis. The In-Line Digital™ option displays a two-dimensional, 360° rotations, and longitudinal view of the vessel.

Here's an analysis of the provided text regarding the In-Vision™ Imaging System's acceptance criteria and studies:

Based on the provided 510(k) summary, the document does not contain specific acceptance criteria tables or detailed performance study results in the manner requested. The submission is a "Special 510(k)" for a software modification (version upgrade to V4.1) of an existing device. For such submissions, the focus is often on demonstrating that the changes do not raise new questions of safety or efficacy, rather than presenting extensive de novo performance data.

Therefore, many of the requested fields cannot be filled directly from this document. However, I can extract the available information and highlight what is missing.

Acceptance Criteria and Device Performance

Not explicitly stated in the document. The document states: "Applicable testing was performed to evaluate the modifications to the In-Vision™ Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols."

This indicates that internal acceptance criteria and protocols were used, but the specific metrics and performance values are not disclosed in this 510(k) summary.

Study Details (Based on Available Information)

Since detailed performance data is not provided, many of these sections will indicate "Not specified in document."

Summary of Information from the Document:

• Device Name: In-Vision™ Imaging System
• Purpose of Submission: Software modification (version upgrade to V4.1) to an existing intravascular ultrasound imaging system.
• Comparison: Claims substantial equivalence to predicate devices based on fundamental scientific technology, intended use, and clinical applications.
• Performance Data Statement: "Applicable testing was performed to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols." This indicates internal testing was done and met predefined criteria, but the specifics are not public in this summary.
• Conclusion: The software modification "raises no new questions about safety and efficacy."

This 510(k) summary focuses on demonstrating that a software update to an already cleared device does not alter its fundamental safety or effectiveness profile, rather than providing a detailed performance study as might be expected for a novel device or an AI/ML product today.

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