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Used for female intermittent self-catheterization of the bladder. Curved design permits easier insertion and makes the catheter easier for patients to manipulate.

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I'm sorry, but this document does not contain the information requested. This document is a 510(k) premarket notification decision letter from the FDA for a urological catheter. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or details about test sets.
3. Details about expert involvement in establishing ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Information about the training set or how its ground truth was established.

The content focuses on regulatory approval based on substantial equivalence to an existing device, rather than detailed performance study results against specific acceptance criteria.

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