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FuStar™ Steerable Introducer is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

The FuStar™ Steerable Introducers are designed to perform as a guiding sheath and/or introducer sheath, which provides a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low-profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of catheters and devices. The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm (Large). In each option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination. Also, the visible knob with scale of controller facilitates the physicians to estimate the deflecting angle of the sheath while intra-operation. The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French size, 5F, 6F, 7F, 8F, 9F and 10F). The deflectable angle of sheath is from 0 degree to 180 degree.

The provided document is a 510(k) Summary for the "FuStar™ Steerable Introducers." This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to predicate devices, enabling its market clearance.

However, this document does not contain information about acceptance criteria, reported device performance in the context of acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies.

The "Testing Conclusion" section lists various types of performance, biocompatibility, and sterilization tests performed (e.g., "Primary Dimension Test," "Bending Test," "Cytotoxicity," "Sterlization Validation"). It states that these tests were conducted "to validate and verify that the proposed device met all design specifications," but it does not provide the acceptance criteria for these tests nor the specific performance results against those criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about study design elements like sample sizes, ground truth, or expert involvement based solely on the provided text.

The document is a regulatory submission summary intended to demonstrate substantial equivalence, focusing on comparisons to legally marketed predicate devices and confirming adherence to general design specifications and safety requirements through various tests, rather than detailing a comparative effectiveness study or specific performance metrics with acceptance criteria.

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