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The Volcano iFR® Harvest Modality is an offline analysis tool of the currently marketed vasodilator-free pressure measurement module, iFR® Modality of the Volcano s5/s5i/CORE and CORE Mobile systems. It is intended to calculate iFR values from hyperemia-free FFR pressure recordings in a laptop or desktop setting only.

The Volcano Harvest iFR® Modality is a software tool designed to calculate offline iFR values from hyperemia-free FFR pressure recordings made using Volcano's s5 v3.2.x software. It takes an existing FFR case file, separates the baseline (iFR) and Pd/Pa (FFR under resting conditions) pressure runs, calculates the iFR values from the baseline runs, and prepares a report summarizing the values. Input case files are collected and archived on the s5 or s5i console from Volcano Corporation.

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The text primarily focuses on the FDA 510(k) clearance process, device description, intended use, and comparison to a predicate device.

Specifically, the document states:

• "Performance testing completed for a determination of substantial equivalence included the following: . Software Verification . Software Validation"
• "The results of the performance data demonstrate equivalence to the predicate device."

However, it does not provide:

1. A table of specific acceptance criteria.
2. Reported device performance values.
3. Sample sizes used for test sets or their data provenance (country, retrospective/prospective).
4. Number of experts or their qualifications for ground truth establishment.
5. Adjudication method.
6. Information on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
7. Details on standalone algorithm performance.
8. The type of ground truth used (e.g., pathology, outcomes data).
9. Sample size for the training set.
10. How ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given information.

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