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The Contiplex C Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or by ultrasound visualization of the device. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle in general and orthopedic surgery.

In set configuration, the B. Braun Contiplex C Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The catheter may remain indwelling for up to 72 hours.

The Contiplex C Continuous Peripheral Nerve Block Needle is a needle comprised of an open tip catheter over an insulated needle with a positioning component, a needle hub with integrated injection tubing and cable, and connection tubing.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML performance (e.g., sensitivity, specificity, AUC, human reader studies, ground truth establishment with experts) are not applicable here.

This submission focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing to ensure the device's safety and effectiveness for its intended use.

Here's an analysis of the provided text in the context of device acceptance, though it won't align perfectly with the AI/ML specific questions due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

Since this is a traditional medical device (a nerve block needle), the "acceptance criteria" are compliance with established performance standards and the "reported device performance" is that the device met these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test. For medical device performance testing, sample sizes are typically determined by statistical methods or industry standards relevant to the specific test (e.g., number of units tested for kink resistance, bond strength, etc.).
• Data Provenance: Not specified. Standard testing for medical devices is usually performed in-house by the manufacturer or by certified contract laboratories, generally under controlled conditions. It is prospective testing of manufactured devices.

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

Not applicable. For this type of device, "ground truth" relates to objective physical and biological properties measured against established standards, not interpretation by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessment. For objective device performance testing, results are typically binary (pass/fail) or quantitative measurements compared against a specification.

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/ML device or a diagnostic device where human reader studies are generally performed.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device's acceptance is adherence to international and national consensus standards (ISO 10993-1, ISO 594-1, ISO 594-2, ISO 7864, ISO 9626, EN 13868) for biocompatibility and functional performance. The device's physical and material properties, and its functional characteristics, are measured against these objective standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML product.

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

Not applicable. There is no "training set" for this product.

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