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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 cathter to its tip via the catheter adapter.

The Paiunk Stimulong Plus Catheter Sets and Plexalong sets are single use, sterile, non-pyrogenic 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 and Plexalong sets consist of a single use sterile, non-pyrogenic conduction needle with tubing, a catheter and catheter adapter. The catheter in the Stimulong Plus Catheter is the same as the catheter in the Plexalong sets except for a conductive ring tip. Continuous delivery is accomplished using the catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the tip of the conduction needle and after placement of the conduction catheter (Stimulong Plus catheter) to its tip via the catheter adapter.

The provided text describes a 510(k) premarket notification for the "Pajunk Stimulong Plus Catheter Sets" and does not contain a study demonstrating device performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, this document focuses on demonstrating substantial equivalence to predicate devices through conformance to recognized consensus standards and biocompatibility testing.

Here's a breakdown based on the information provided and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document states that "The testing included verifying conformance to these standards." This implies the device met the criteria outlined in these standards. The acceptance criteria themselves are the specific requirements within each standard. No numerical performance metrics (like accuracy, sensitivity, specificity) are provided as this is not a diagnostic device or a device with a quantifiable performance output in that manner.

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

This information is not provided in the given text.

• The primary "testing" referenced is conformance to recognized standards, which might involve material testing or functional testing per those standards, but not a "test set" in the context of an AI/ML algorithm or clinical study.
• The document describes device components and their equivalence to previously cleared devices.

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

This information is not applicable and not provided.

• This device is a medical instrument (catheter sets, needles) and does not involve AI or image analysis where expert-established ground truth would be relevant.
• The "ground truth" here is adherence to engineering standards and safety/biocompatibility requirements.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

• There's no mention of a "test set" or adjudication in the context of human interpretation for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided.

• This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable and not provided.

• This device does not involve an algorithm, so a standalone performance study in that context is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness determination is established through:

• Conformance to Recognized Consensus Standards: This implies the device meets pre-defined engineering, material, sterilization, and quality requirements. Examples include ISO 594 for Luer fittings, DIN EN 550 for ETO sterilization, and DIN EN ISO 10993-1 for biocompatibility.
• Biocompatibility Testing: Specifically mentioned for the conductive tip, wire, and alternate plastic material, per DIN EN ISO 10993-1.
• Substantial Equivalence: Comparison to predicate devices (K033018, K013041, K000722, K023218, K030937) for existing design elements and materials.

8. Sample Size for the Training Set

This information is not applicable and not provided.

• This is not an AI/ML device, so there is no "training set."

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

This information is not applicable and not provided.

• As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: K043130 is a 510(k) premarket notification for a medical device (anesthesia conduction kits) aimed at demonstrating substantial equivalence to legally marketed predicate devices. The "study" proving it meets acceptance criteria primarily involves showing conformance to a list of recognized national and international consensus standards related to materials, manufacturing, sterilization, biocompatibility, and risk management. It does not involve clinical studies with outcome measures or performance evaluations typical of diagnostic or AI-driven technologies.

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