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The ShapelT catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature.

The device is contraindicated for use in the neurovasculature.

The ShapelT is a guide wire support catheter intended to be used in the coronary and/ or peripheral vasculature for patients suffering from coronary or peripheral artery disease. The target lesion can be reached by using the femoral or brachial approach. The ShapelT is a single lumen 0.014" rapid exchange catheter. The 135 cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The ShapeIT distal end is preshaped to support guidewire redirection in bifurcations.

The ShapelT catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.

I'm sorry, but the provided text does not contain information about acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an Artificial Intelligence (AI) enabled medical device.

The document is a 510(k) Premarket Notification from the FDA for a medical device called "ShapeIT," which is a percutaneous catheter. The purpose of this document is to declare the device substantially equivalent to legally marketed predicate devices, not to present a study proving performance against AI-related acceptance criteria.

The information provided details:

• Device Name: ShapeIT
• Regulation Name: Percutaneous Catheter
• Product Code: DQY
• Intended Use: To support a guide wire during access of coronary and/or peripheral vasculature.
• Technological Characteristics: Comparison to a predicate device (Micro Rx Guidewire support catheter), highlighting similarities and differences (e.g., angulated tip and shapeable distal section).
• Performance Tests: A list of performance tests conducted on the ShapeIT catheter (e.g., Kink resistance, Tensile strength, Coating integrity) to demonstrate its design verification and substantial equivalence to the predicate device.
• Biocompatibility Tests: A list of biocompatibility tests performed in accordance with ISO 10993-1.

There is no mention of:

• AI or an algorithm
• A test set or data provenance for AI
• Experts establishing ground truth for AI
• Adjudication methods for AI
• MRMC studies for AI
• Standalone performance for an AI algorithm
• Types of ground truth for AI
• Training set size or how ground truth was established for a training set in an AI context.

Therefore, I cannot fulfill your request for the specific details about AI acceptance criteria and a study proving those criteria were met based on the provided text.

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