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The PreView Forward-Looking IVUS Catheter and Laptop System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.014" guidewire lumens. The PreView Forward-Looking IVUS Catheter is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.

The PreView® Forward-Looking IVUS Catheter and Laptop System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.

The PreView® Forward-Looking IVUS Catheter and Laptop System is an IVUS catheter with stand-alone laptop imaging system. The PreView® Catheter is a single use disposable device with a disposable single use motor for rotation of the catheter. The catheter is 135cm in length and connects to a PIM (Patient Interface Module) which contains the electronics. The PIM translates the echo data and sends it to the laptop for display on the computer screen.

The provided text is a 510(k) summary for the Volcano PreView® Forward-Looking IVUS Catheter and Laptop System. It describes the device, its intended use, and states that non-clinical device testing was conducted to confirm performance. However, it does not provide specific acceptance criteria or detailed results of a study demonstrating the device meets those criteria.

The document lists various types of non-clinical testing performed, such as dimensional verification, simulated use performance, and biocompatibility, but it does not quantify acceptance criteria (e.g., "Dimensional Verification: within +/- X mm") nor does it present the results of such tests in a comparative table.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Bench testing was conducted against known standards, product specification, or against the predicate device and evaluated the following:" followed by a list of tests.

• Acceptance Criteria: Not explicitly defined/quantified in the document (e.g., "known standards," "product specifications").
• Reported Performance: The document only states that these tests were "conducted" and "successfully completed" for biocompatibility tests, and that completion of all tests "concluded the PreView® Forward-Looking IVUS Catheter and Laptop System is substantially equivalent to the predicate device." No specific performance metrics or values are provided.

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

• Sample Size: Not specified for any of the listed tests.
• Data Provenance: The tests are non-clinical (bench testing, biocompatibility testing, GLP animal safety study). The document refers to "known standards" and "product specifications" and comparison against a "predicate device." There is no mention of human subject data, and thus no country of origin or retrospective/prospective information applies.

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

• Not applicable as the testing described is non-clinical (bench and animal studies). No human expert ground truth establishment for a test set is mentioned.

4. Adjudication Method for the Test Set:

• Not applicable due to the non-clinical nature of the testing.

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

• No MRMC study mentioned. The document focuses on non-clinical testing for substantial equivalence.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is an IVUS catheter system, not an AI algorithm. No standalone algorithm performance is discussed.

7. Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" would be established by:
  • Known standards: For tests like Dimensional Verification, Acoustic Power Output.
  • Product specifications: For various performance characteristics.
  • Predicate device comparison: For tests where performance was benchmarked against the existing predicate.
  • GLP Animal Safety Study: The outcome of this study served as evidence for animal safety.

8. Sample Size for the Training Set:

• Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."

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

• Not applicable for the same reason as above.

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