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Boston Scientific's Tracker™ Excel™-14 Pre-Shaped Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils into the peripheral, coronary, and neuro vasculature.

The Tracker™ Excel™-14 Pre-Shaped Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft astifiess ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged individually with a variety of pre-shaped tips.

The provided text describes a 510(k) submission for a modified microcatheter and does not contain information about an AI-powered device or a study involving AI. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or AI effectiveness studies.

The document focuses on demonstrating substantial equivalence of the modified microcatheter to a predicate device based on in-vitro testing and biological safety testing, as well as a comparison of product characteristics.

Regarding the specific questions you asked, based on the provided text, the following cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available as it pertains to AI-powered devices.
2. Sample sized used for the test set and the data provenance: Not relevant for this type of device modification submission. The text mentions "in-vitro testing" but doesn't detail sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it pertains to AI ground truth.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable for an AI device. The ground truth for this device's performance would be the physical properties and biological safety as measured in the in-vitro tests.
8. The sample size for the training set: Not applicable as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

Summary of the provided information:

• Device: Tracker™ Excel™-14 Pre-Shaped Microcatheter
• Modification: The predicate device (Tracker™ Excel™-14 Microcatheter) was modified to include pre-shaped tips, as opposed to a straight, steam-shapeable tip.
• Purpose of Modification: Ease of use for physicians.
• Testing Conducted: In-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile strength of tip, buckling test, and coil, guidewire and guide catheter compatibility) and biological safety testing.
• Conclusion of Testing: The results support the claim of substantial equivalence to the predicate device.
• Substantial Equivalence Claims: Functionality, intended use, indications for use, materials, method of operation, and biological safety.
• Predicate Device: Tracker™ Excel™-14 Microcatheter (K994155).

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