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The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vasular system and is designed to assist in the placement and removal of catheters.

The Intravascular Access Introducer Sheath is a sterile single use Sheath intended to facilitate the placement and removal of vascular catheters, it is manufactured from polvurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and removing catheters. The device is supplied sterile and are packaged individually in a tray sealed with a Tyvek® lid

This 510(k) summary (K063650) describes an application for an intravascular access introducer sheath. The document does not contain the kind of information typically associated with studies demonstrating the performance of AI-powered medical devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a traditional, non-software medical product.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of AI/software device evaluation. The provided text discusses:

• Substantial Equivalence: The primary goal of this 510(k) is to show that the Applied Medical Intravascular Introducer System is substantially equivalent to previously cleared Applied Medical products (K041506, K890766) and the Johnson & Johnson Cordis Avanti+ Introducer Set.
• Device Description and Intended Use: It describes the physical characteristics and the intended clinical application of the sheath.
• Non-clinical Testing: Mentions "Bench top testing was conducted and comparisons were made to the predicated devices." This is typical for physical medical devices to ensure they meet basic functional and safety requirements, often comparing physical properties like tensile strength, flow rates, or insertion forces. It does not refer to clinical studies or performance against a ground truth as would be relevant for an AI/software device.
• Biocompatibility: States that materials are biocompatible according to ISO 10993-1.
• Design Controls and Risk Analysis: Discusses adherence to regulatory standards (21 CFR § 820.30, EN 1441, ISO 13485, AAMI/ISO TIR 14971) for design, risk, validation, and verification.

In summary, the provided document is for a traditional medical device (an introducer sheath) and does not involve AI or software components requiring the types of studies or performance metrics you've asked for (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance).

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