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The Symbiq™ Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute Facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.

Symbiq™ Infusion System includes a volumetric piston-driven infusion pump and utilizes dedicated disposable administration sets for fluid delivery to the patient. The pump's plunger cyclically pressurizes the administration set's cassette pumping chamber through an elastomeric diaphragm to deliver fluid. The device has a touchscreen user interface to program various therapies. At low flow rates the infusion pump is designed to maintain low flow continuity. The infusion pump utilizes drug safety software to set hospital drug dosing parameters. The system can communicate wired or wirelessly over the hospitals network infrastructure through Hospira MedNet™ server software with Hospital Information Systems. The pump is available in one-channel and two-channel configurations.

Here's a breakdown of the acceptance criteria and study information for the Symbiq™ Infusion System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the "Accuracy" row in the comparison table with the predicate device. The results summary for the non-clinical tests all state "Pass," indicating conformity with the respective standards.

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

The document does not explicitly state the numerical sample size used for the test set in terms of specific patient or simulated cases. It refers to "System verification and validation activities" and "Human Factors Use Safety Validation study."

• Sample Size for Test Set: Not explicitly quantifiable from the provided text for the performance tests (e.g., accuracy, safety). For the Human Factors Study, it only states "no instances of participants failing to complete tasks correctly," implying some number of participants were involved, but the exact count is not given.
• Data Provenance: The document does not specify the country of origin for any data. It does indicate that "System verification and validation activities" were conducted, as well as a "Human Factors Use Safety Validation study," suggesting these were prospective tests designed for this submission.

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

This information is not provided in the document. The document mentions "user needs and design inputs" being met, and a "Safety Assurance Case" being generated, but does not detail expert involvement in establishing ground truth for performance testing or the Human Factors study beyond general "trained healthcare professional" for data entry and validation of infusion parameters in the Intended Use section.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned. The device described is an infusion pump, and the studies mentioned are focused on the device's technical and user safety performance, not on AI-assisted interpretation by human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

The performance testing (e.g., accuracy, electrical/mechanical safety) evaluates the device's inherent functionality, which can be considered "standalone" in that it's testing the direct output of the pump system. The human factors study involved users, but the "Performance Test Summary-New Device" describes the system meeting "user needs and design inputs," and refers to "static analysis of the software code," which would be a standalone evaluation of the algorithm/software.

7. The Type of Ground Truth Used

Based on the nature of the device (infusion pump) and the tests described:

• Technical Performance (Accuracy, Safety, EMC, Alarms): The ground truth would be established by objective measurements against predefined engineering specifications and regulatory standards (e.g., measured flow rate vs. programmed flow rate, electrical safety limits, alarm signaling conditions).
• Biocompatibility: Established by laboratory testing against ISO 10993-1.
• Human Factors: The ground truth for correct task completion would be defined by the intended operational steps and the absence of user errors as observed during the study.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. The "software" refers to drug safety software and system communication, implying a traditional software development and testing cycle, not a machine learning model that requires a distinct training set.

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

As no training set is mentioned in the context of machine learning/AI, this question is not applicable. For the software and system development, the "ground truth" would be the functional requirements and design specifications that the system was built to meet.

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