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Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.

GentleCath Air for Women is a sterile, single use, disposable, hydrophilic, intermittent urethral catheter. A urethral catheter is a tubular device intended for being introduced into the urinary bladder through the urethra in order to provide drainage of the bladder. The catheter tube is made using Thermoplastic Elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. GentleCath Air for Women is designed for portability, ease of use and discreet disposal. Catheters are individually packed and are wetted ready for use upon removal from the case. Catheters are available in the following product sizes: CH10, 12, and 14.

This document describes the GentleCath Air for Women intermittent urinary catheters (CH10, CH12, CH14). The information provided is from a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the details about specific acceptance criteria and the study proving it are largely in reference to a comparison with established standards and the predicate device.

Here's the breakdown of the requested information based on the provided text:

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

The document does not provide a direct table of specific acceptance criteria with corresponding performance metrics like a typical medical device performance study would. Instead, it refers to performance testing conducted per applicable sections of voluntary and FDA consensus standards. The "Performance Data" section lists the types of testing performed and the standards used, indicating that the device met the requirements of these standards.

Here's a summary of the performance testing categories and the standards referenced, which imply the acceptance criteria are adherence to these standards:

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

The document does not provide specific sample sizes for any of the performance tests. It lists the types of tests performed and the standards followed, implying that the sample sizes were appropriate for those standards.

The provenance of the data is not explicitly stated as "country of origin" or "retrospective/prospective." However, the submission is from "ConvaTec, Ltd., First Avenue, Deeside Industrial Park, Deeside, Flintshire CH5 2NU, United Kingdom," suggesting the testing was likely conducted in or overseen by this entity.

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

This type of information (expert review for truth establishment) is not present in the provided document, as it pertains to device performance testing against engineering and biological standards, not diagnostic interpretation.

4. Adjudication method for the test set

Not applicable, as this is related to expert review of diagnostic cases, which is not the focus of this 510(k) submission.

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

Not applicable. This device is an intermittent urinary catheter and does not involve AI or human "readers" or diagnostic interpretation in the context of an MRMC study.

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

Not applicable, as this device does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by adherence to the referenced international and FDA consensus standards. For example, for biocompatibility, the ground truth is defined by the criteria within ISO-10993-1. For flow rate, the "ground truth" is meeting the specified flow rate limits of ISO 20696.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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