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The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.

The PAINfusor Catheter is a closed tip multi-holed catheter with a fenestrated length that incorporates micro-holes in a helical pattern that allow for homogenous flow of analgesia into a surgical wound. The PAINfusor Catheter is radiopaque and has graduated markings along the length of the catheter for positional reference. It is supplied and packaged as a kit with a peel-away introducer needle, occlusive wound dressing and catheter securement adhesive.

The PAINfusor Catheter has been validated through various tests, however, it is important to note that the provided text describes equivalence to predicate devices and does not detail a study involving AI or human readers. Therefore, several sections of your request related to AI performance, human reader improvement, and ground truth for training/test sets cannot be filled from this document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for the "test set" in terms of number of catheters or other units. It refers generically to "testing" and "bench testing." The data provenance is derived from internal testing conducted by the manufacturer, Plan 1 Health, S.r.l., as part of the 510(k) submission process. Given the nature of bench testing, this would be a prospective evaluation of newly manufactured devices.

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

This information is not provided in the document. The "ground truth" for the performance criteria (e.g., flow rate, kink diameter, adhesive strength) would be established by engineering specifications and testing standards (like ISO 10555-1), not by expert consensus in a clinical sense.

4. Adjudication method for the test set

Not applicable. The performance evaluation was based on objective measurements against engineering specifications and international standards, not on subjective assessments 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. This document describes a medical device (a catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or reported.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the device's performance was primarily based on objective engineering and performance specifications defined by international standards (e.g., ISO 10555-1) and internal design requirements. For biocompatibility, it was based on standardized biocompatibility testing protocols (ISO 10993).

8. The sample size for the training set

Not applicable. The PAINfusor Catheter is not an AI algorithm, so there is no concept of a "training set" in the context of this document.

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

Not applicable, as there is no training set for this device.

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