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The Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction catheter to its tip via the catheter adapter.

The Paiunk Stimulong Plus Catheter Sets are single use, sterile, nonpyrogenic and latex free conduction anesthesia sets intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. The Stimulong Plus Catheter sets consist of a single use sterile, non-pvrogenic conduction needle with tubing, a conduction catheter and catheter adapter. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction catheter to its tip via the catheter adapter.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Pajunk Stimulong Plus Catheter Sets. This document is a regulatory submission for a medical device and does not describe the acceptance criteria or a study proving the device meets those criteria, as one would typically find for an AI/ML powered device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and does not raise new questions of safety and effectiveness.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here is a breakdown of why each specific point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria for the device in the way that, for example, a diagnostic AI system would have accuracy thresholds. Its performance is implicitly linked to its substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance: No test set or data provenance is mentioned. The submission relies on comparison to existing legally marketed devices.
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): No ground truth establishment or expert involvement in a study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method 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 not an AI-powered device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned in the context of a performance study.
8. The sample size for the training set: Not applicable, as this is not a device with a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable, for the same reason as point 8.

In summary, the provided text describes a 510(k) submission for a non-AI medical device (anesthesia catheter sets) seeking clearance based on substantial equivalence to predicate devices, not on the results of a performance study with acceptance criteria in the manner expected for an AI/ML-powered device.

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