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The FFR Link ™ is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLabTM POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable.

During a fractional flow reserve procedure, the FFR Link receives, and transmits aortic (Pa) and distal (Pd) blood pressure signals. On a continuous basis, the FFR Link receives the Pd input from a Boston Scientific pressure guidewire, and Pa input from an invasive blood pressure (IBP) transducer cable. The FFR Link converts the Pd and Pa pressures to both a digital and an analog signal. The digital signal can be wirelessly transmitted to iLab Polaris Multi-Modality Guidance System. The analog signal for the Pa and Pd blood pressure can be connected by a cable for output to a hemodynamic display monitor.

The provided document is a 510(k) summary for the Boston Scientific FFR Link, FFR Signal Processing Module. It describes the device, its intended use, and its comparison to a predicate device.

Crucially, this document states that "As no design changes were made to the currently marketed FFR Link device, no additional performance testing is required to establish substantial equivalence." This means that the document does not describe a new study to prove the device meets acceptance criteria. Instead, it relies on the previous clearance (K151613) for the predicate device, stating that "Bench, animal, electrical safety and EMC testing data submitted in K151613 remain valid and applicable to the proposed version of the FFR Link device."

Therefore, I cannot provide details on a new study or acceptance criteria based on this submission. The information you are requesting would have been part of the K151613 submission for the original FFR Link device or the iLab Polaris Multi-Modality Guidance System.

However, I can extract the following information from the provided text regarding the current 510(k) submission:

1. A table of acceptance criteria and the reported device performance: This document does not present new acceptance criteria or reported device performance because no new testing was performed for this submission. It relies on the previous clearance.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this submission as no new testing was conducted.

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 for this submission as no new testing was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this submission as no new testing was conducted.

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: Not applicable. This device is a signal processing module, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a signal processing module, not an algorithm being tested for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this submission as no new testing was conducted.

8. The sample size for the training set: Not applicable. This device is a signal processing module, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This device is a signal processing module, not a machine learning algorithm.

In summary, the provided document explicitly states that:

• "As no design changes were made to the currently marketed FFR Link device, no additional performance testing is required to establish substantial equivalence."
• "Bench, animal, electrical safety and EMC testing data submitted in K151613 remain valid and applicable to the proposed version of the FFR Link device."

Therefore, for the specific 510(k) submission K170204, there is no new study or acceptance criteria described, as it relies on the substantial equivalence to its predicate device based on previous testing.

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