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The Resolve® Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.

The Resolve® Biliary Drainage Catheter consists of single lumen tubing with two suture holes and 17 to 18 drainage holes in the distal curve region. It is made from a biocompatible thermo-plastic. A hydrophilic coating reduces entry site/catheter friction during placement. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffener, flexible plastic stiffener, straightener and repositioning tool. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. Once the catheter position is established in the area to be drained, the pigtail is formed by retracting a suture which is looped from the hib, to the catheter tip and back to the hub.

The hub incorporates a suture locking mechanism to retain the distal pigtail shape. It may be unlocked using the repositioning tool to allow repositioning or replacement of the cather. A single reditorsale marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct.

The provided document describes the Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter and its 510(k) submission for substantial equivalence to a predicate device. However, this document does not contain a study that proves the device meets specific acceptance criteria in the way typically expected for a medical device efficacy or performance study involving clinical data or quantifiable metrics against predefined thresholds.

Instead, the submission focuses on substantial equivalence testing against a predicate device. This type of P510(k) submission primarily relies on demonstrating that the new device has "the same intended use and the same technological characteristics as the predicate device" or "has the same intended use as the predicate device and different technological characteristics, but the new device does not raise different questions of safety and effectiveness than the predicate device."

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of quantifiable performance metrics for the ReSolve® Biliary Drainage Catheter itself. Instead, the "acceptance criteria" are implied by the process of demonstrating substantial equivalence to a predicate device. The performance data demonstrates equivalence, which is the "reported device performance" in this context.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "bench testing" and "comparison tests with the predicate device," but does not specify the sample size for these tests.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's bench testing, it would be laboratory-based and not human clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the evaluation relies on bench testing and comparison to a predicate device, not on expert-adjudicated clinical test sets for diagnostic accuracy or similar performance metrics.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence through bench testing to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This information is not applicable. The device is a physical medical catheter, not an AI algorithm or software. Therefore, there's no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

• For the bench testing, the "ground truth" would be the engineering specifications and performance of the predicate device, as well as relevant international standards and Merit's in-house protocols for safety and effectiveness (e.g., material properties, mechanical integrity, fluid dynamics). There is no "ground truth" established in the sense of clinical outcomes or pathology data for this type of submission.

8. Sample Size for the Training Set

• This information is not applicable. The device is a physical catheter, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the same reasons as point 8.

In summary: The provided 510(k) summary demonstrates substantial equivalence through bench testing by showing that the ReSolve® Biliary Drainage Catheter has a similar intended use, technological characteristics, and comparable performance to a legally marketed predicate device (UreSil Hydrophilic-coated Chole-Cath® Biliary Drainage Catheter). The document does not describe a study involving human subjects or AI, nor does it present specific acceptance criteria with quantifiable metrics for a clinical performance study. The "proof" of meeting acceptance criteria is the successful demonstration of substantial equivalence to the predicate device through engineering and performance comparisons.

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