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The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.

The Skater® Biliary Drainage Catheter is a polyurethane catheter with SLIP-COAT™, a lubricious hydrophilic coating.. The catheter comes in a pigtail-loop, locking-type, end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula, and a standard luer locking hub.

This document is a 510(k) Summary for the Skater® Biliary Drainage Catheter, detailing its regulatory submission to the FDA. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with detailed acceptance criteria and expert reviews in the way typically found for AI/ML-driven diagnostic devices.

Therefore, the requested information, particularly regarding specific acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment in the context of a performance study, is largely not present in this document. The document describes product characteristics and safety/performance testing, which are manufacturing and preclinical assessments, not clinical performance studies for diagnostic accuracy.

Here's a breakdown of what can be gleaned from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

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

• Not explicitly stated for a clinical performance study. The document refers to "in vitro bench tests" and "biocompatibility testing," which are typically laboratory-based assessments, not clinical trials with human subjects or large datasets. No specific sample sizes for these tests are provided.
• Data Provenance: Not applicable in the context of a clinical performance study. The tests mentioned are laboratory/bench tests, not trials with patient data.

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

• Not applicable. This information is relevant for diagnostic accuracy studies involving expert human review of images or data to establish a ground truth. The document describes bench and biocompatibility testing, which do not involve expert human interpretation for ground truth.

4. Adjudication method

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert human interpretation, which is not described as part of the testing here.

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

• No. This type of study is for evaluating AI-assisted diagnostic performance. The Skater® Biliary Drainage Catheter is a medical device (catheter) and not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission.

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

• No. This concept is for AI algorithms. The device itself is a physical medical instrument.

7. The type of ground truth used

• Benchmarking/Standard Measurements: For dimensional inspection, LAL, bioburden, EO/EC residual, and potentially other in vitro tests, the "ground truth" would be established by industry standards, validated measurement methods, and predefined acceptance limits (e.g., a specific dimension, a maximum endotoxin level, sterility).
• Biocompatibility Standards: For biocompatibility, the ground truth is established by recognized international standards (e.g., ISO 10993 series) and specific in vitro/in vivo tests designed to evaluate potential adverse biological reactions.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of medical device submission, as it does not involve machine learning or AI models. The device is evaluated through engineering, chemical, and biological testing, not by training an algorithm.

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

• Not applicable. As there is no training set, this question is not relevant.

In summary: This 510(k) submission confirms that the Skater® Biliary Drainage Catheter underwent various safety and performance tests (dimensional, process, biocompatibility, aging, LAL, bioburden, EO/EC residual) and was found comparable to its predicate devices. However, it does not involve the type of clinical performance study details (e.g., test set, expert review, AI accuracy metrics) that would be pertinent to AI/ML diagnostic tools.

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The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.

The Skater® Biliary Drainage Catheter is made from hydrophilic coated polyurethane. The catheter comes in a pigtail-loop, locking-type end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula and a standard luer locking hub.

The provided text describes a 510(k) submission for the "Skater® Biliary Drainage Catheter" and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving it meets specific acceptance criteria through a clinical study or performance goals set for a new, non-inferiority claim.

Here's a breakdown based on the information provided, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goals: The document does not explicitly state quantitative "acceptance criteria" or performance goals in terms of specific metrics (e.g., accuracy, sensitivity, specificity, or success rates) for the device's clinical function. Instead, it aims to demonstrate substantial equivalence to a predicate device.

Reported Device Performance:
The document does describe the types of tests performed.

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

The document mentions "in vitro bench tests" but does not specify sample sizes for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as it pertains to clinical performance data, because no clinical performance study is described. The tests conducted appear to be laboratory-based engineering and material property tests.

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

This information is not applicable and not provided. The device comparison is based on bench testing and material characteristics, not on interpretations by medical experts for clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As no expert-based ground truth establishment or clinical performance study is detailed, no adjudication method would have been used.

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

An MRMC study was not done. This type of study is commonly used for diagnostic accuracy of image-based AI devices, which is not the nature of this device. The submission is for a medical catheter, and the evidence provided focuses on physical and material characteristics compared to a predicate device.

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

A standalone study was not done. This is also relevant for AI/software devices, which this catheter is not. The performance evaluation is for the physical device itself.

7. Type of Ground Truth Used

The "ground truth" for the tests performed (functional, leakage, tensile strength, physical dimensions) would have been the engineering specifications and established testing standards for medical devices of this type, as well as comparison against the performance of the predicate device. It is not based on expert consensus, pathology, or outcomes data, as these are typically used for clinical performance evaluations.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical catheter, not an AI or machine learning algorithm, so there is no "training set."

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

This information is not applicable and not provided for the same reason as point 8.

Summary of the Study:

The study described is a series of in vitro bench tests and biocompatibility testing designed to demonstrate that the "Skater® Biliary Drainage Catheter" is substantially equivalent to the "Boston Scientific Corporation, Flexima™ Biliary Catheter (K023870)" predicate device. The tests covered functional performance, leakage, tensile strength and elongation of the catheter body, physical dimensions, and catheter body to hub tensile strength. The conclusion is that the new device performs "comparably" to the predicate in these areas, and that the combined results of these tests and biocompatibility testing demonstrate its safety and effectiveness. The report does not involve clinical trials, expert reviews of clinical cases, or AI performance metrics.

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