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The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.

The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.

The FX catheters are regional anesthesia catheres intended to provide, via percutaneous administration, continuous and/or internittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. The catheters may remain indwwelling for up to 72 hours. Routes of administration are epidural (peripheral nerve block (PNB)). The catheter is available in both open and closed tip designs. The open-tip polyamide catheter is intended to facilitate continuous delivery of anesthetic fluid via one opening at the tip, while the closed-tip polyamide catheter facilitates the administration of anesthetic through three sideports. Both catheters have ink markings, which are located in 10 mm increments along the catheter. The ink markings provide a visual indication of the depth of catheter insertion. When used according to the conditions listed on the product labeling, the FX Catheters may remain in a patient while in an MR environment.

This document is a 510(k) summary for the Perifix FX Catheter and Contiplex FX Catheter manufactured by B. Braun Medical Inc. It concerns a traditional medical device (anesthesia conduction catheters) and does not involve Artificial Intelligence (AI). Therefore, the questions related to AI device performance, such as acceptance criteria for AI, training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to this submission.

The 510(k) submission (K231242) focuses on demonstrating substantial equivalence to predicate devices (K991879 and K113059). The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

"MRI testing was performed. Testing supports the device being labeled as MRI Conditional. No changes have been made to the device therefore, the device continues to be safe and effective and performs the same as the predicate device."

This indicates that the primary testing performed was related to MRI compatibility, and the unchanged nature of the device from its predicates means that prior safety and efficacy data for the predicates are considered applicable.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details because this 510(k) submission is not for an AI device.

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The B. Braun Contiplex® FX Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.

The B. Braun Continuous Nerve Block Set consists of one 17 gauge Tuohy needle, one 19 gauge springwound catheter with threading assist guide, one sideport valve assembly, and one clamp style catheter connector. The set is used to facilitate the continuous delivery of anesthetics or analgesics to the patient for pain management during regional anesthesia procedures.

The provided text is a 510(k) Premarket Notification for the B. Braun Contiplex FX Continuous Nerve Block Set. It describes the device, its intended use, and indicates that performance testing and biocompatibility testing were conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for performance or biocompatibility testing. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily benchtop/laboratory-based for device characteristics rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for this medical device's performance is established by its adherence to internationally recognized engineering and biocompatibility standards, rather than expert consensus on clinical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective measurements against engineering standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (nerve block set), not an AI diagnostic tool or imaging system that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical tool, not an AI algorithm. Its performance is evaluated through physical and material testing, not algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for establishing the safety and effectiveness of the Contiplex FX Continuous Nerve Block Set is adherence to international consensus standards for medical device design, manufacturing, and biocompatibility. This includes:

• Engineering standards (e.g., ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, EN 1618) for physical properties and functional performance of the needle and catheter components.
• Biocompatibility standards (ISO 10993-1) for the materials used.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device's evaluation, as it's not an AI/machine learning product. The testing is based on device characteristics against predetermined standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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