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The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.

Veta™ Peritoneal Dialysis Catheters are side-ported silicone catheters with a single and double retention cuff, available in a range of lengths and French sizes and in either a straight or spiral tip configuration.

The provided document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-driven medical devices. This document refers to a conventional medical device (Veta™ Peritoneal Dialysis Catheter), and its clearance is based on in vitro testing and substantial equivalence to predicate devices, rather than performance metrics from clinical or AI-specific studies.

Therefore, most of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "test set" in this context refers to physical samples of the catheter used for in vitro engineering tests, not a dataset of patient cases. The specific number of catheters tested is not provided, but it would have been sufficient to meet the standards.
• Data Provenance: Not applicable. This was in vitro testing, not clinical data from patients.

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

• Not applicable. Ground truth for in vitro engineering tests is established by adhering to published performance standards (e.g., BS EN 1618-1997) and verified by standard laboratory test methods, not by expert consensus on medical images or diagnoses.

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

• Not applicable. This is not a study requiring adjudication of clinical findings.

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 MRMC study was done (or is relevant) as this is not an AI-driven device.

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

• No standalone algorithm performance was done (or is relevant) as this is not an AI-driven device.

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

• The "ground truth" for the in vitro tests was defined by compliance with established engineering and biocompatibility standards (BS EN 1618-1997 and ISO 10993).

8. The sample size for the training set

• Not applicable. This device did not involve machine learning; therefore, there was no training set.

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

• Not applicable. There was no training set.

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