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The Cordis Cyst Puncture Catheter Kit is intended to facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage.

The Cordis Cyst Puncture Catheter kit consists of a ventricular catheter with enlarged holes whose distal tip has been modification allows the sharpended stylet to be inserted through and locked into the distal tip. This facilitates cyst puncture. The kit also includes sharp- and blunt-ended stylets to facilitate catheter placement. The catheter is manufactured from silicone elastomer made radiopaque with barium sulfate.

This is a 510(k) premarket notification for a medical device (Cordis Cyst Puncture Catheter Kit) submitted in 1996. The provided text is a summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

In the context of 510(k) submissions from this era, a "study that proves the device meets the acceptance criteria" as you've described for AI/software devices is not typically conducted or summarized in this manner. Instead, the focus is on showing similarity in design, materials, manufacturing, and intended use to legally marketed predicate devices, and that these similarities do not raise new questions of safety or effectiveness.

Therefore, many of the specific questions you asked are not directly applicable or answerable from the provided text for this type of medical device submission. However, I can extract information related to what is present and explain why other information is absent.

Here's a breakdown of what can be inferred or stated based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not specify formal, quantitative "acceptance criteria" for performance in the way a modern AI/software device would. The core "acceptance" is that the device is substantially equivalent to predicate devices. This means that its design, materials, manufacturing methods, and intended use are similar enough not to raise new questions of safety or effectiveness.

Unanswerable or Not Applicable Questions (Based on the Provided Text)

The following questions cannot be answered from the provided text because they pertain to clinical or performance studies typically conducted for devices requiring more extensive proof of safety and effectiveness (e.g., PMA devices, or modern AI/software devices) or for which specific data is not detailed in a Summary of Safety and Effectiveness for a 510(k).

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of controlled clinical trials or AI evaluation is described. The submission relies on substantial equivalence to predicate devices, which generally means no new clinical data demonstrating performance in a "test set" is required for the 510(k) pathway.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable. No test set adjudication is described.

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: Not applicable. This is a medical device (catheter kit), not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware medical device, not an AI algorithm.

7. The type of ground truth used: Not applicable in the conventional sense of clinical trials. The "ground truth" for a 510(k) is that the predicate devices are safe and effective, and the new device is sufficiently similar.

8. The sample size for the training set: Not applicable. This is a hardware medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable. This is a hardware medical device.

In summary: The provided document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices. It relies on comparisons of design, materials, and intended use, rather than presenting clinical study data with defined acceptance criteria and performance metrics typical of more rigorous clinical trials for novel devices or AI/software. The "proof" of meeting "acceptance criteria" (which are implicit substantial equivalence) is the argument that the device is "similar to predicate devices and does not raise any new issues relating to safety and effectiveness for their intended use."

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