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This device is used for temporary endoscopic drainage of the pancreatic duct through the nasal passage by use of an indwelling catheter.

The Nasal Pancreatic Drainage Set consists of a drainage catheter, nasal transfer tube and drainage connecting tube. The drainage catheter has flaps, side ports and a touby-borst connector. The drainage catheter flaps are located at the distal end of the catheter. The flaps help prevent migration hereby helping the drainage catheter to remain in the desired position. The side ports, also located the distal end of the drainage catheter, these help assist in drainage of pancreatic fluid. The touhy borst connector allows connection of the drainage catheter to the drainage connection tube; it also allows the drainage catheter to be flushed. The drainage connection tube allows the drainage catheter to be connected to a drainage collection bag. In the middle of the drainage connecting tube is a three way stopcock; this allows a flow through the drainage connecting tube during the procedure. The nasal transfer tube enables the drainage catheter to be threaded through the oral cavity and out through the nostril. The drainage catheter contains radiopaque material which allows the user to ensure the drainage catheter is accurately positioned using fluoroscopically.

The provided document describes the acceptance criteria and performance data for the Cook Nasal Pancreatic Drainage Set (K171623), as determined through bench testing and biocompatibility evaluations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document primarily describes bench testing and biocompatibility testing. For these types of tests, individual samples of the device components or finished product are used.

• Sample Size: Not explicitly stated as a single number across all tests. Each test would have its own sample size, typically a small number of devices or components to demonstrate compliance with specifications. For example, "the test article" for resistance to collapse, flow rate, and leakage implies individual units were tested.
• Data Provenance: The device manufacturer is Cook Ireland Ltd. The testing was performed as per Cook Ireland's design control system and in line with 21 CFR 820.30, including FDA recognized standards. This indicates the testing was conducted internally or by a contracted lab on behalf of Cook Ireland, likely in Ireland. This is prospective testing, as it's directly conducted to demonstrate the performance of the manufactured device.

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

• This information is not applicable to the type of studies described. The "ground truth" for bench tests and biocompatibility is established by objective measurements and standardized protocols (e.g., measuring force, flow rate, or observing cellular reactions), not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are not clinical trials or image interpretation studies requiring expert adjudication.

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

• No, an MRMC comparative effectiveness study was not performed and is not mentioned in the document. The submission focuses on substantial equivalence based on technological characteristics and non-clinical performance data (bench and biocompatibility testing).

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not performed. This device is a physical medical device (catheter set), not an AI algorithm. Therefore, "algorithm only performance" is irrelevant.

7. Type of Ground Truth Used

• Objective Measurement/Standardized Protocols: The "ground truth" for the performance criteria is defined by the objective quantitative or qualitative measurements specified in the referenced international standards (e.g., ISO, ASTM, EN, JIS) and Cook Ireland's design parameters. For biocompatibility, the ground truth is the biological response observed according to the specific test methods outlined in ISO 10993.

8. Sample Size for the Training Set

• This information is not applicable. The document describes a traditional medical device (catheter set) where performance is established through physical and biological testing, not through machine learning or AI models that require training sets.

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

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

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The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

The Tria™ Firm Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically or fluoroscopically or during an open surgical procedure. It is constructed of the same Percuflex polymer as other stents currently marketed by BSC. Tria Firm utilizes a modified extrusion process to provide ureteral stents with an ultra-smooth surface topography.

The Tria™ Firm stent has a double pigtail design and utilizes the same monofilament retrieval lines that are used on other BSC ureteral stents. Tria Firm is packaged with a standard straight stent positioner and a pigtail straightener that are currently provided with other ureteral stents marketed by Boston Scientific.

The purpose of the Tria™ Firm Ureteral Stent is to provide physicians with a product that is aimed at addressing accumulation of urine salt deposits during indwelling. The proprietary surface technology on both the outside and inside of the stent provides maximum coverage from calcium and magnesium salt deposition.

This document is a Premarket Notification (510(k)) for a medical device, the Tria™ Firm Ureteral Stent. It describes the device, its intended use, and why it is considered substantially equivalent to existing devices.

Crucially, this type of FDA submission (510(k)) primarily focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical effectiveness through extensive clinical trials with acceptance criteria for specific outcomes, especially in the context of an AI/algorithm-driven device performance study.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for an AI/algorithm is not applicable or present in this document.

The document does mention performance testing for the physical device itself (ureteral stent) and an in vitro study related to a claim about reduced salt accumulation.

Here's an analysis based on the provided document, with explanations for why much of your query cannot be answered:

Analysis of the Provided Document Regarding Device Acceptance and Study

This document describes the regulatory submission for a physical medical device (Tria™ Firm Ureteral Stent), not an AI/algorithm. Thus, the "acceptance criteria" discussed are primarily regulatory in nature (e.g., demonstrating substantial equivalence, biocompatibility, structural integrity, and flow rate of the stent), rather than performance metrics for an AI's diagnostic or predictive capabilities.

The study mentioned is an in vitro test, not a clinical study on human subjects or an AI performance study.

Information Extracted from the Document:

1. A table of acceptance criteria and the reported device performance:
   • The document does not provide a clear, quantifiable table of acceptance criteria for "device performance" in the way you'd expect for an AI/algorithm (e.g., sensitivity, specificity, AUC). Instead, it lists types of performance tests for the physical stent.
   • The closest to a quantifiable performance statement is for the in vitro test on salt accumulation.

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

   • Test Set Sample Size: Not specified for any of the performance tests (e.g., how many stents were tested for flow rate or tensile strength). For the in vitro salt accumulation study, the "sample size" of stents tested is not provided, only that it was a "statistically significant" finding.
   • Data Provenance: Not applicable in the context of patient data for an AI/algorithm. All studies appear to be bench (laboratory) tests performed by Boston Scientific or third parties.

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

   • Not applicable. This is for a physical medical device. Ground truth for most tests (e.g., tensile strength, flow rate) is established by physical measurement standards, not expert consensus interpretation of images or clinical data.
   • For the in vitro salt accumulation study, ground truth would be based on lab measurements of salt deposits, not expert readings.

4. Adjudication method for the test set:

   • Not applicable. This is not an AI/imaging interpretation study. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses/interpretations, not for physical device testing.

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 was not done. MRMC studies are specific to evaluating AI in diagnostic imaging (human-in-the-loop performance). This document is for a physical ureteral stent.

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

   • No, this was not done. This is not an algorithm.

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

   • For the physical/mechanical performance tests, the "ground truth" is based on engineering measurements and material science standards.
   • For the biocompatibility tests, it's based on established ISO/USP standards for biological reactivity.
   • For the in vitro salt accumulation study, the "ground truth" refers to laboratory measurements of calcium and magnesium salt deposition. No human expert or pathology report is involved in establishing this ground truth.

8. The sample size for the training set:

   • Not applicable. This document is not describing an AI/machine learning model, so there is no training set in that context. Device design and manufacturing process optimization would be an analogous "training" phase but without a formal "training set" of data points in the AI sense.

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

   • Not applicable for the same reason as #8.

Key takeaway concerning the in vitro claim:

The document explicitly states: "In vitro testing conducted on the Tria™ Firm Ureteral Stent showed a statistically significant lower level of urine calcium and magnesium salt accumulation on the stent surface compared to competitive devices. Correlation of in vitro data to clinical outcomes have not been established." This is a critical disclaimer, indicating that while the lab test showed a positive result, it has not been proven to translate to better patient outcomes in terms of reduced encrustation or longer stent patency in actual human use.

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