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The Cordis Suction Reservoir Kit is intended to be used with the Cordis Subdural Drainage Catheter for drainage of extraventricular fluid collections.

The kit consists of a Suction Reservoir and an extension tubing with an integrated male Luer connector. The Suction Reservoir has a 100 cc capacity with graduated markers every 25 cc allowing measurement of fluid collections. It also incorporates an anti-reflux valve to prevent backflow. The Suction Reservoir provides consistent negative pressure while returning to its original shape and volume.

This document is a Summary of Safety and Effectiveness for a medical device submitted to the FDA, specifically the Cordis Suction Reservoir Kit. It is a pre-market notification (510(k)) and does not contain the type of detailed performance criteria, study design, and results typically found in publications for AI/ML device approval.

Therefore, I cannot provide the information requested in your numbered list. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through rigorous clinical studies with AI components.

Here's why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe quantitative performance metrics or acceptance criteria beyond functional statements like "provides consistent negative pressure." There are no reported device performance numbers.
2. Sample size used for the test set and the data provenance: There is no mention of a "test set," "sample size," or data origin for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of ground truth establishment by experts for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
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: This device is a physical suction reservoir, not an AI/ML-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no mention of ground truth as it pertains to performance evaluation in the context of AI/ML or complex diagnostic devices.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable, for the same reason as above.

In summary, the provided text describes a traditional medical device (a suction reservoir) and seeks 510(k) clearance based on substantial equivalence, not on the performance metrics and study types associated with AI/ML device evaluations.

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