Search Results

The Avail Sterile Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.

A sterile, water filled, single patient use syringe designed for catheter inflation only. Not for injection. The syringes are bulk packaged for sale to customers for inclusion in urological kits. The syringes are not marketed or sold as separate devices from urological kits. The intended use of the device is to provide a sterile liquid for Foley catheter inflation after insertion. The syringe cap is removed, the syringe luer tip connects directly to the catheter valve. The sterile water is expressed to inflate the catheter. The syringe is disconnected and discarded after use.

The provided submission, K112209, is for a Sterile, Water Filled Syringe (Pre-filled Catheter Inflation Syringe) by Avail Medical Products Inc. This device is not a software/AI device, but rather a medical device intended for catheter inflation. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, expert involvement, and AI-related metrics (like MRMC or standalone performance improvement) are not applicable to this type of submission.

Here's a breakdown of the relevant information from the document, acknowledging the limitations for a non-AI product:

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

Since this is a non-AI medical device, the "acceptance criteria" are related to its physical and functional characteristics, and substantial equivalence to a predicate device, rather than diagnostic performance metrics.

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

This information is not applicable as there was no "test set" in the context of an AI study. The "testing" referred to in the document is non-clinical performance and materials testing, not data-driven evaluation with a clinical test set.

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

This information is not applicable as there was no "test set" and no ground truth established by experts in the context of an AI algorithm's performance.

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

This information is not applicable as there was no "test set" requiring adjudication.

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:

No, an MRMC comparative effectiveness study was not done. This is a non-AI medical device; such a study is not relevant.

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

No, a standalone performance study in the context of an AI algorithm was not done. This is a non-AI medical device.

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

This information is not applicable as there was no "ground truth" in the context of evaluating an AI algorithm's performance. The "ground truth" for this device's functionality would be that it effectively and safely inflates catheters as intended, confirmed through engineering and biocompatibility testing.

8. The sample size for the training set:

This information is not applicable as there was no "training set" for an AI algorithm.

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

This information is not applicable as there was no "training set" for an AI algorithm.

Ask a specific question about this device