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Indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The guidewires are designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

The Jagtail™ High Performance Guidewire Extension attached to the extendable Jagwire™ 260 cm Guidewire is designed for use during endoscopic biliary procedures for non-rapid exchange catheter introduction and exchanges. The attachment of the Jagtail High Performance Guidewire Extension to the extendable Jagwire 260 cm guidewire creates an extended guidewire that can be used to exchange out a non-rapid exchange biliary catheter without removing the original guidewire from the associated duct. When the exchange is completed, the Jagtail High Performance Guidewire Extension can be detached and the original, extendable Jagwire 260 cm guidewire can be used in a conventional manner.

Jagwire™ High Performance Guidewire, and Jagwire™ High Performance Extendable Guidewire:
The Boston Scientific Jagwire™ High Performance Guidewire is constructed of a metal alloy core, which is encapsulated in a striped PTFE jacket with a 5 cm hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings.

Jagtail™ High Performance Guidewire Extension:
The Boston Scientific Jagtail™ High Performance Guidewire Extension is a 200 cm long guidewire extension constructed of a stainless steel core with a connector at the distal end. The shaft is coated with a PTFE sleeve. The Jagtail High Performance Guidewire Extension is exclusively compatible with the Jagwire High Performance Extendable Guidewire, 260 cm. The distal end of the Jagtail High Performance Guidewire Extension is inserted into the proximal end of the extendable Jagwire 260 cm guidewire with the use of the alignment tool. The alignment tool is then removed from the Jagtail High Performance Guidewire Extension.

The provided document is a 510(k) premarket notification for a medical device called "Jagwire™ High Performance Guidewire" and its extensions. It is not an AI/ML device, therefore, a lot of the metrics that you requested are not relevant here. However, I will extract and provide the relevant information.

The document discusses the regulatory approval for a guidewire, which is a physical medical device used in endoscopic biliary procedures. The "acceptance criteria" and "study" described in the document relate to the physical and biological performance of this guidewire, rather than an AI/ML algorithm's diagnostic or predictive capabilities.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not specify a "sample size" in the context of an algorithm's test set or data provenance (e.g., country of origin, retrospective/prospective) because this applies to a physical device, not a data-driven model.

• Sample Size for Testing: Not explicitly stated as "sample size" in the context of a dataset. Instead, it refers to multiple units of the physical device or its components tested.
• Data Provenance: Not applicable as it's not a data-driven study, but rather a performance evaluation of a manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic studies, not for the physical performance testing of a medical guidewire. The performance was assessed against established engineering and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are used in diagnostic studies to resolve discrepancies in expert opinions for ground truth establishment. For physical device testing, the results are typically quantitative measurements against predefined specifications.

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:

This is not an AI/ML device, so no MRMC comparative effectiveness study involving human readers or AI assistance was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not an AI/ML device, so no standalone algorithm performance was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established by engineering specifications, material science standards (e.g., biocompatibility standards like ISO 10993-1), and mechanical performance metrics. The device is deemed acceptable if it meets these predefined physical and biological requirements.

8. The sample size for the training set:

This information is not applicable. The device is a physical product, not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set for a physical medical device.

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