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Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.

Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments.

The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized.

The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier.

The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations:

• Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
• Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
• Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) .

The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr).

This document is a 510(k) Summary for a medical device (Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not to present a comparative effectiveness study or a detailed algorithm performance study for an AI/ML enabled device.

Therefore, the provided text does not contain the information required to populate most of the fields in your request, such as a formal acceptance criteria table with reported performance specific to an AI device, sample sizes for test/training sets of AI models, details about expert ground truth establishment, or MRMC study results. The non-clinical performance testing described focuses on standard medical device validation (e.g., sterilization, biocompatibility, physical properties) rather than AI model performance.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Device Performance Study (Non-AI Device)

This document is a 510(k) submission for a non-AI medical device (Hydrophilic Intermittent Catheter). The "acceptance criteria" here refer to testing to ensure the device meets established standards and performs comparably to predicate devices, rather than a statistical performance threshold for an AI algorithm. The "study" refers to non-clinical bench testing, packaging tests, aging tests, and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical medical device (catheter) and not an AI device, "acceptance criteria" and "reported device performance" are described in terms of compliance with relevant international standards and successful bench testing, rather than metrics like sensitivity, specificity, or AUC for an AI model. Therefore, a table structured for AI performance metrics is not directly applicable. However, we can reframe the "acceptance criteria" as the types of tests performed and the "reported device performance" as compliance with those tests and standards.

2. Sample Size for Test Set and Data Provenance

This document describes a medical device (catheter) validation, not an AI/ML model study. Therefore, the concept of a "test set" in the AI/ML sense (a dataset used to evaluate a trained model) does not apply. The validation involves various physical, chemical, and biological tests on samples of the manufactured device. The document does not specify the exact number of units or samples used for each bench test, but it indicates the tests were performed to demonstrate compliance with relevant standards.

• Date Provenance: The manufacturing entity is Well Lead Medical Co., Ltd. in Guangzhou, China. The testing would have been conducted on devices manufactured within their facility or by contracted laboratories. The origin of the data (i.e., test results) is from these non-clinical, controlled tests. It is not "retrospective" or "prospective" in the clinical study sense for data collection.

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

Not applicable. For a physical medical device like a catheter, "ground truth" is established by adherence to engineering specifications, material properties, sterility, and biocompatibility. This is determined through objective testing against widely accepted standards (e.g., ISO, ASTM), rather than by expert consensus on clinical data similar to an AI diagnostic device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies or AI algorithm validation where expert disagreement on ground truth labels needs to be resolved. For standard device testing, compliance to a defined physical, chemical, or biological specification is measured objectively.

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

Not applicable. An MRMC study assesses the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). This device is a physical catheter, not an AI-enabled diagnostic tool.

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

Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's validation is based on:

• Compliance with international standards (e.g., ISO, ASTM for sterility, biocompatibility, physical properties).
• Objective measurements from bench testing (e.g., pH, osmolarity, strength, seal integrity).
• Established material science and biological compatibility criteria.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a "training set."

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

Not applicable. This is not an AI/ML algorithm.

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