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Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.

A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water. The products are designed for transient use only and are available in male and female lengths. The products are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH14, CH16, CH18. An increasing Charrière corresponds to a larger external diameter. The male catheter range also consists of variants with a bent (Tiemann) catheter tip shape.

The provided document is a 510(k) summary for the ConvaTec GentleCath™ Glide Intermittent Urinary Catheter. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on performance testing and comparison of characteristics.

Here's an analysis of the acceptance criteria and study in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a medical device's clinical performance (e.g., sensitivity, specificity for diagnostic devices). Instead, it demonstrates "substantial equivalence" to predicate devices through a series of bench tests and comparison of device characteristics. The acceptance criteria are implicitly that the subject device's performance in these tests is "similar or superior" to the predicate devices.

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

The document does not specify the sample size used for the bench tests (flow rate, tensile properties, coefficient of friction, angle of Coudé tip).
The data provenance is from laboratory testing performed by ConvaTec Limited (UK-based company). It is implicitly retrospective as it compares the new device to existing predicate devices.

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

This information is not provided in the document. Given that the testing consisted of bench tests, the "ground truth" would likely be established by validated test methods and instrumentation, rather than expert review of clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the document describes bench testing, not a clinical study involving human judgment that would require an adjudication method.

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

An MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (intermittent urinary catheter), not an AI-assisted diagnostic tool. Therefore, effects on human readers or AI assistance are not relevant.

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

This is not applicable as the device is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation mostly relies on bench test measurements against established engineering and material science standards (e.g., ISO and EN standards) and comparative performance against legally marketed predicate devices. For biocompatibility, the ground truth is established by the results of specific ISO-standardized biological evaluations (e.g., cytotoxicity, sensitization, irritation reports).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device (catheter); there is no "training set" in the context of machine learning or AI models. The design and manufacturing process are based on engineering principles and materials science.

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

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

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