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The CathAssist™ Female Urinary Catheter Insertion Accessory is used to assist routine adult female urethral catheterization in both hospital and office settings. Some of the clinical situations in which female catheterization is indicated include:

1. Major surgery;
2. Urinary retention;
3. Collection of a sterile "cath" urine specimen;
4. Bladder irrigation; and
5. Labor and Delivery.
   The CathAssist™ Female Urinary Catheter Insertion Accessory is intended for use by:
6. Nurses and caregivers in the rapid and easy insertion of a female urinary catheter;
7. By adult females who are required to perform intermittent self catheterization following surgery; and
8. By adult females required to self-catheterize and who have motor or visual disabilities.

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The provided FDA letter does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and a study proving device performance for the "CathAssist" device. The letter is a 510(k) clearance document, which confirms substantial equivalence to a predicate device but does not typically include a detailed performance study summary or specific acceptance criteria met by the device itself, beyond the general understanding that it functions as intended for its stated indications for use.

Based only on the provided text, here's what can be extracted and what cannot:

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

This information is not available in the provided document. The 510(k) letter confirms clearance based on substantial equivalence, but it does not detail specific acceptance criteria (e.g., success rates, complication rates) established for the CathAssist device itself, nor does it report the device's performance against such criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided document. The letter does not describe any specific test set or clinical study conducted for the CathAssist device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided document. No test set or related ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided document.

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

Given that "CathAssist" is described as a "Female Urinary Catheter Insertion Accessory" and not an AI-powered diagnostic imaging device, it is highly unlikely that an MRMC comparative effectiveness study involving human readers (like radiologists) and AI assistance would have been conducted or would be relevant. This information is not available and not applicable given the device type.

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

This concept is not applicable to a physical medical device like a catheter insertion accessory. There is no "algorithm only" performance for such a device. This information is not available.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document.

8. The sample size for the training set

This information is not available in the provided document. No training set is described.

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

This information is not available in the provided document. No training set or ground truth establishment is described.

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