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The Talon Surgical CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the heart through the interatrial septum.

The Talon Surgical CardioCurve Steerable Sheath is a 8.5F sterile, single-use, catheter introducer used for the introduction, withdrawal, and exchange of guidewires and catheters while minimizing blood loss. It is available in lengths of 40, 61, 71 or 82 cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, market cleared guidewire (K935170). A side port with three-way stopcock allows blood aspiration, fluid infusion, and pressure monitoring. An integrated Tuohy Borst adaptor is designed to hold a guidewire or catheter in place. The steerable sheath features distal side holes to facilitate aspiration and minimize cavitation, and a stainless-steel ring for visualization under fluoroscopy.

The handle is equipped with two linked rotating dials used to deflect the tip clockwise and counterclockwise 180°.

The CardioCurve Steerable Sheath shaft is made from barium loaded Pebax and Nylon and includes a radiopaque tip marker for visibility under fluoroscopy and is braided, except for the distal tip, for kink resistance; the handle is made of ABS. The dilator is made of HDPE that is barium loaded for visibility under fluoroscopy

The CardioCurve Steerable Sheath Dilator can be used with a curved transseptal St. Jude Medical BRKTM type needle with stylet if indicated on the package label.

The provided document is a 510(k) summary for the Talon Surgical CardioCurve™ Steerable Sheath. This specific type of document, primarily focused on demonstrating substantial equivalence to a predicate device for FDA clearance, does not contain the detailed, quantitative performance metrics and study design elements typically associated with acceptance criteria and a detailed study proving a device meets those criteria for AI/ML-driven diagnostics.

The document describes performance testing for a catheter introducer (a physical medical device, not an AI/ML diagnostic). The testing ensures the device meets its design requirements and is safe and effective for its intended use, focusing on physical and biocompatibility attributes.

Therefore, I cannot provide the requested information (Acceptance Criteria, Device Performance Table, Sample Sizes, Expert Ground Truth, Adjudication, MRMC studies, Standalone performance, Training set details) as this document does not pertain to an AI/ML diagnostic device and its performance evaluation in the way you've outlined.

The "Performance Testing" section on page 10 lists various types of tests conducted on the physical device, such as:

• Visual Inspection
• Dimensions
• Guidewire Compatibility
• Dilator Compatibility
• Deflection and retention
• Shaft tip buckle
• Air and liquid leakage per ISO 11070:2017
• Hub compatibility with ISO 80369-7
• Stopcock compliance per ISO 594
• Tensile Strength per ISO 11070
• Distribution and Packaging Tests per ASTM D4169:2016 and ISO 11607-1
• Packaging Aging per ASTM F1980
• Biocompatibility per ISO 10993-1 (covering Cytotoxicity, Sensitization, Irritation, Toxicity, Hemocompatibility, and a Thrombogenicity Study in Ovine Model).

The document states: "All testing met the requirements and passed. There are no new questions raised regarding safety or efficacy of the CardioCurve Steerable Sheath."

To reiterate, the information requested is specific to the evaluation of AI/ML diagnostic models, which is not what this FDA 510(k) summary describes.

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