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The Medex 3000 Series Syringe Infusion Pump indications for use are as follows; - in the administration of fluids requiring precisely controlled infusion rates including . blood or blood products, lipids, drugs, antibiotics and other therapeutic fluids. - in the following delivery routes: arterial, epidural, intravenous, spinal, and . subcutaneous. - . in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. - in critical care, anesthesia, neonatal and pediatric applications or other healthcare . settings where the use of the Syringe Infusion Pump can be monitored or supervised by a clinician. - . the Syringe Infusion Pump is contraindicated for use on the inlet side of extracorporeal membrane oxygenation (ECMO) systems where high negative pressures may occur.

The Syringe Infusion Pump is a software driven, microprocessor controlled, electromechanical system that contains within its case: user interface, power supply, motor, pumping mechanism, and electronic circuits required to effect the controlled infusion of fluids through a syringe and a sterile administration set. The pump operates by controlled displacement of the syringe plunger.

Acceptance Criteria and Study for Medex 3000 Series Syringe Infusion Pump

This document outlines the acceptance criteria for the Medex 3000 Series Syringe Infusion Pump and the study conducted to demonstrate that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary does not explicitly state the numerical acceptance criteria for a "reduction in post-occlusion bolus volume." It only states that testing was conducted to confirm a reduction compared to the predicate device.

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

The 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It simply states that "Medex conducted flow rate testing" and "Medex conducted testing to confirm that the 3000 Series Syringe Infusion Pump delivered a reduction in post-occlusion bolus volume."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a syringe infusion pump, and the performance criteria are objective measurements of mechanical and fluid delivery accuracy, rather than clinical assessments requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not performed as the device is a syringe infusion pump and not an AI or imaging-based diagnostic or assistive technology. The study focused on objective device performance metrics.

6. Standalone Performance Study

A standalone performance study was performed. The testing described for flow rate accuracy and post-occlusion bolus reduction was conducted on the Medex 3000 Series Syringe Infusion Pump as a standalone device, without human-in-the-loop assistance.

7. Type of Ground Truth Used

The ground truth used for these tests would be based on objective measurements from calibrated instruments that measure flow rate and volume, consistent with engineering and metrology standards for medical devices. This is not "expert consensus, pathology, or outcomes data."

8. Sample Size for the Training Set

This information is not applicable as the Medex 3000 Series Syringe Infusion Pump is a hardware device with software controls, and the testing described does not involve machine learning algorithms that require a specific "training set" in the conventional sense. The "training" for such a device would be part of its design validation and verification processes, not a distinct dataset for a learning algorithm.

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

As per point 8, this question is not applicable. The "ground truth" for the device's design and verification would be its engineering specifications and the validated performance of its components and overall system against established industry standards and regulatory requirements.

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