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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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