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The PeriFuse™ regional anesthesia Catheter is indicated for use during procedures where intermittent administration of local anesthetics is indicated for control of operative, postoperative, acute or chronic pain for peripheral nerve block procedures. The duration of use should not exceed 72 hours.

The PeriFuse™ Catheter is an echogenic regional anesthesia catheter intended to enhance visibility of the catheter under ultrasound guidance. The PeriFuse™ Catheter is made of flexible nylon tubing and comes in two versions. One version is a closed end with 3 lateral eyes. The second version is an open end with a finished tip. The catheters are available as 21G (O.D. 0.83mm nominal/I.D. 0.41mm nominal) and have a nominal length of 944mm. They will be provided as sterile, single use, disposable devices. The PeriFuse™ Catheter tip is marked for ease of identification and to ensure complete catheter removal. The catheter is extruded using a patented Smiths Medical technology which leaves a surface finish that is slightly textured on both the inner diameter and outer diameter. The PeriFuse™ Catheter may be packaged in either a catheter kit or may be included in Smiths Medical regional anesthesia trays (K965017).

The provided text describes a 510(k) submission for the PeriFuse™ Catheter and explicitly states that no clinical data was required for this submission. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

The submission focuses entirely on non-clinical data to establish substantial equivalence to predicate devices. The non-clinical testing conducted included mechanical, functional, and performance evaluations, demonstrating compliance with "stated sections of BS 6196:1989 Sterile epidural catheters and introducer needles for single use."

Since no clinical study was performed, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable based on the provided document.

Here's an attempt to fill in the table and address the questions based solely on the information given, highlighting what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A). No clinical test set or data provenance from a clinical study is mentioned. Non-clinical testing was performed, but specific sample sizes for these tests are not provided in the summary.

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

• N/A. No ground truth established by experts for a clinical test set is mentioned.

4. Adjudication method for the test set

• N/A. No clinical test set or adjudication method 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

• N/A. No MRMC study performed. The device is a medical catheter, not an AI diagnostic tool involving human readers.

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

• N/A. The device is a medical catheter, not an algorithm.

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

• For the non-clinical performance evaluation, the "ground truth" was compliance with specified sections of BS 6196:1989 Sterile epidural catheters and introducer needles for single use. This standard itself would define the performance metrics and acceptable ranges.
• For substantial equivalence, the "ground truth" was the technological characteristics and indications for use of the predicate devices.

8. The sample size for the training set

• N/A. No training set for an algorithm is applicable.

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

• N/A. No training set for an algorithm is applicable.

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