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The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. The device is provided sterile in a sealed Tyvek pouch and carton with IFU.

The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire and includes a proximal hub with a female luer tapered fitting for flushing.

This document is a 510(k) premarket notification for a medical device (Steerable Introducer 12F), seeking a determination of substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and performance data from various tests. However, it does not describe an AI/ML-based device or its acceptance criteria and study in the context of AI/ML performance.

The information provided in the document refers to a physical medical device (a steerable catheter introducer) and its non-AI related performance testing (e.g., dimensional, material, mechanical, biocompatibility, sterilization).

Therefore, I cannot extract the information required by your prompt, as it specifically asks for details related to an AI/ML device's acceptance criteria and the study proving it meets those criteria.

The provided text does not contain any information about:

1. AI/ML Acceptance Criteria or Device Performance: There is no mention of metrics like sensitivity, specificity, AUC, or any other performance indicators typically used for AI/ML models.
2. Test Set Sample Size or Data Provenance: This document is about a physical medical device, not a software algorithm tested on data.
3. Experts for Ground Truth/Adjudication: This concept is not applicable here.
4. MRMC Comparative Effectiveness Study: Not relevant for a physical device.
5. Standalone AI Algorithm Performance: There is no AI algorithm.
6. Type of Ground Truth: Not applicable.
7. Training Set Sample Size or Ground Truth Establishment: Not applicable.

The document focuses on:

• Device Description: Physical attributes and components.
• Intended Use & Indications for Use: What the device is meant to do (introduce catheters into the heart).
• Technological Characteristics: How it operates (bi-directional steering, radiopacity).
• Performance Data: Bench testing (e.g., deflection, kink resistance, hemostasis), biocompatibility testing (ISO 10993-1), and sterilization methods, all aimed at demonstrating the device's safety and effectiveness as a physical product.
• Substantial Equivalence Claim: Comparing the new device's features and performance to a legally marketed predicate device (FlexCath Advance K123591) to show it's "as safe and effective."

In conclusion, based on the provided text, I cannot answer your request as it pertains to AI/ML device performance and testing. The document describes a traditional physical medical device.

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