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The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ PV imaging catheter (H749364560) is a sterile, single use, over-the-wire (OTW) imaging catheter with a 8F distal crossing profile and a transducer capable of producing a frequency of 15MHz and a 8F distal crossing profile. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound Imaging Systems: iLab™ (K072517), Galaxy2/Galaxy™ (K980851), and Clearview™ Ultra (K921750). The Atlantis™ PV catheter consists of two main assemblies: Catheter body and Imaging Core. The catheter body is comprised of two sections: Dual lumen and Telescoping section (shaft). The dual lumen section is the "working length" of the catheter. The dual lumen is an over-the-wire (OTW) design containing an imaging core lumen and a guidewire lumen. The telescoping section remains outside of the introducer sheath. The telescoping shaft allows the imaging core to be advanced and retracted for 25 cm of linear movement. The corresponding movement of the transducer occurs inside the imaging core lumen. The catheter body is attached to the telescope shaft via a y-manifold with male/female luer connection. The straight leg of the y-manifold is the guidewire exit port with a female luer thread. The luer thread allows flushing of the guidewire lumen. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking ultrasonic transducer at the distal tip. The distal ends of the imaging core and the catheter body are radiopaque for visualization of the imaging plane and the catheter tip. An electro-mechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) / Instrument. The MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection.

This 510(k) premarket notification for the Boston Scientific Atlantis™ PV Imaging Catheter (K080272) is a submission for a modified device, referencing a previously cleared predicate device (Atlantis™ PV Imaging Catheter, K050684). As such, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than presenting new clinical study data to establish performance against acceptance criteria for a novel device.

Therefore, many of the requested sections regarding acceptance criteria and a dedicated study to prove these are not applicable or cannot be extracted directly from this document. The document confirms that the device meets performance requirements through non-clinical testing for bench, biocompatibility, and sterility, implying that the acceptance criteria are related to these technical and safety aspects, which are deemed consistent with the predicate device.

Here's the information that can be extracted or reasonably inferred based on the provided text, with explanations for the unavailable sections:

Acceptance Criteria and Device Performance Study for K080272

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "The performance test results for bench, biocompatibility and sterility testing of the Atlantis™ PV Imaging Catheter demonstrate that the device meets or exceeds the performance requirements for the specified intended use." It does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. The primary acceptance criterion for this 510(k) is demonstrating substantial equivalence to the predicate device, K050684, for "performance requirements."

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

This information is not provided in the document. The submission references "non-clinical test results" for bench, biocompatibility, and sterility, but it does not specify sample sizes for these tests or the origin of any data (e.g., retrospective or prospective, country of origin), as these are typically part of detailed test reports that are not included in the summary.

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

This information is not applicable/not provided because this submission primarily relies on non-clinical testing and substantial equivalence to a predicate device. There is no mention of a clinical "test set" requiring expert ground truth establishment in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. The Atlantis™ PV Imaging Catheter is an intravascular ultrasound catheter, a diagnostic imaging device which (based on this document) does not incorporate Artificial Intelligence (AI) to assist human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

This information is not applicable/not provided. This device is a hardware imaging catheter, not an algorithm. Standalone algorithm performance studies are not relevant here.

7. The Type of Ground Truth Used

This information is not applicable/not provided in the context of clinical performance data for this 510(k) submission. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and methods for assessing bench performance, biocompatibility, and sterility, rather than expert consensus, pathology, or outcomes data typically associated with clinical studies of diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is an imaging catheter and not an AI/machine learning algorithm, so there is no concept of a "training set" in this submission.

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

This information is not applicable/not provided for the same reason as in point 8.

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