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Classic™ intermittent catheters are intended for use in Mate, Female and Paediatic patients when regular assisted bladder drainage has been instructed by a physician. Classic™ intermittent catheters are indicated for use by individuals whose ablity to void the bladder fully by natural bodily functions is impaired.

Classic ™ Intermittent Catheter is a PVC plastic device that is intended to be inserted through urethra and into bladder of patient to allow drainage of urine. The Classic Intermittent catheter in pouch consists of a tube which is bonded onto a drainage funnel. Classic™ Intermittent Catheter has a round polished finish tip to provide maximum comfort for user. Each catheter features two large evelets in order to drain urine efficiently. Drainage eyelets cut-outs are smooth and rounded to minimize the risk of injury/discomfort when in use. Classic ™ Intermittent Catheters are available in: Adult Male. Available in coude tip or straight tip Adult Female. Available in straight tip Paediatic. Available in straight tip

Here's an analysis of the provided text regarding the acceptance criteria and study for the Classic™ Intermittent Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Classic™ Intermittent Catheter are defined by adherence to specific international and in-house standards, with the reported performance being that "All samples pass" for each test.

2. Sample Size for Test Set and Data Provenance

The document mentions "All samples pass" for each test, implying a test set was used for performance and physical characteristic evaluations. However, the exact sample size used for the test set is not explicitly stated in the provided text.

The data provenance is primarily from in-house testing conducted by Flexicare Medical Limited and evaluations against international standards (BS EN and ASTM). The country of origin of the data is the United Kingdom, where Flexicare Medical Limited is located. The nature of the testing (physical performance, material analysis, biocompatibility) indicates this is prospective data generated specifically for the device's evaluation.

3. Number of Experts and Qualifications for Ground Truth

This device is a physical medical device (intermittent catheter) and the evaluation is based on objective, measurable physical, chemical, and biological properties, not a subjective interpretation like medical imaging. Therefore, there is no concept of "experts establishing ground truth" in the way it applies to diagnostic AI systems. The ground truth is defined by the objective pass/fail criteria of the specified standards and in-house test methods.

4. Adjudication Method

Given the nature of the testing for a physical device, adjudication methods like 2+1 or 3+1 are not applicable. The tests performed have clearly defined pass/fail criteria based on objective measurements and adherence to standards. The "Outcome" column clearly states "All samples pass," indicating a direct evaluation against the established criteria.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for comparing the performance of different human readers (potentially with and without AI assistance) in tasks involving subjective interpretation, such as diagnostic imaging. The Classic™ Intermittent Catheter is a physical device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. The device is a physical catheter, not a software algorithm. Therefore, the concept of "algorithm only" performance is not applicable here.

7. Type of Ground Truth Used

The ground truth used for evaluating the Classic™ Intermittent Catheter is based on:

• Objective Measurement against Standards: Adherence to established international standards (e.g., BS EN 1616, ASTM F623-99, ISO 10993-7) for physical dimensions, flow rates, tensile strength, leak integrity, and biocompatibility.
• In-house Test Methods and Specifications: Specific internal tests developed by Flexicare Medical Limited for properties like tensile testing, tube hardness, and connection forces.

Essentially, the ground truth is defined by the pass/fail criteria stipulated within these standards and documented test methods.

8. Sample Size for Training Set

No "training set" is applicable or mentioned. This device does not use an AI algorithm that requires training data. The "samples" referenced in the "Summary of Testing" are test units of the manufactured catheter used for performance verification.

9. How Ground Truth for Training Set Was Established

Since there is no AI algorithm or training set, this question is not applicable.

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