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The Visions PV 8.2F catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions PV 8.2F ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Visions PV 8.2F catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and defects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The Visions PV 8.2F catheter utilizes an internal lumen that allows the catheter to track over the 0.038" (0.97 mm) guide wire. The Visions PV 8.2F catheter is introduced percutaneously or via surgical cutdown into the vascular system.

The provided text is a 510(k) summary for the Volcano Corporation Visions® PV 8.2F Intravascular Ultrasound Imaging Catheter. It focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, intended use, and performance data from internal testing.

Therefore, the document does not contain the information required to populate the fields related to acceptance criteria, specific study designs (like MRMC or standalone), ground truth establishment, sample sizes for test/training sets, or expert qualifications.

The text states:

• Performance Data: "Applicable testing was performed in accordance with the Validation Test Report and the Risk Analysis was reviewed to assess the impact of the change in materials to the device. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the acceptance criteria. Shelf life testing of the device was performed due to this change in materials."
• Conclusion: "The Visions PV8.2F Intravascular Ultrasound Imaging Catheter has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device... Modifications to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the subject device to the predicate device."

This indicates that internal validation and risk analysis were performed, and biocompatibility and shelf-life tests met "acceptance criteria." However, the specific metrics for these acceptance criteria or the detailed results (beyond "met the acceptance criteria") are not provided.

Based on the provided text, the requested table cannot be fully completed, and most of the specific study details are not available.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The text only mentions "Applicable testing was performed" for biocompatibility and shelf life. There is no mention of a "test set" in the context of imaging performance, as this submission is for minor material and shelf-life changes to an already cleared device.

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)

• Not applicable/Not provided. Ground truth establishment for imaging performance is not described, as the submission focuses on substantial equivalence for material/shelf-life changes.

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

• Not applicable/Not provided.

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. This is a 510(k) for an intravascular ultrasound catheter, not an AI-assisted diagnostic device.

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

• No. This is not an algorithmic device.

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

• Not applicable/Not provided in the context of imaging performance. For biocompatibility, the ground truth would be established by the ISO 10993-1 standard. For shelf-life, it would be stability data over time.

8. The sample size for the training set

• Not applicable/Not provided. This is not a machine learning or AI device.

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

• Not applicable/Not provided.

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