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The Infusomat® Space Volumetric Infusion Pump System is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids, medications, blood products through clinically accepted routes of administration. These routes include intravenous, intra-arterial, subcutaneous, and epidural.

The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities.

The Infusomat® Space Volumetric Infusion Pump System includes an external, electronic infusion pump and pump accessories. The pump is transportable within a facility.

The Infusomat® Space pump utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting.

The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products.

The Infusomat® Space is powered by an external power supply or by a rechargeable battery.

Infusomat® Space is capable of wireless communication both inbound and outbound.

SpaceStation with SpaceCom: The B. Braun Space Station is an 115V AC powered flexible docking and communication system for use in a medical facility. It is designed to accommodate multiple Infusomat® Space volumetric infusion pumps. SpaceCom is a communication device that has been integrated into the SpaceStation. SpaceCom supports different interfaces such as Ethernet, PS2-Keyboard, Serial, USB ports and WLAN network card. Data transfer with the pumps is provided via an internal CAN bus. For barcoding, a barcode image reader can be connected to the PS2-Keyboard or USB interface. The pumps are coupled together with connectors on the inner backside of the SpaceStation. These connectors provide the voltage supply, distribute the information in the Space system via a serial interface, transfer data via a bus system (CAN bus) and transmit a staff call, which may be pending.

Drug Library Manager and Drug Upload Manager: The Space OnlineSuite is a server based software system which provides the following applications: Space Server Core, Drug Library Manager (DLM), Upload Manager (ULM).

This document is a 510(k) summary for the Infusomat® Space Volumetric Infusion Pump System, submitted to the FDA. It declares substantial equivalence to a predicate device and outlines performance data for non-clinical testing.

Here's the breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or specific quantifiable performance metrics in a way that can be directly extracted and put into a table. Instead, it describes general compliance with intended use and safety standards.

However, based on the "PERFORMANCE DATA NON-CLINICAL TESTING" section, the following areas were tested to demonstrate substantial equivalence and functionality:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the sample sizes (e.g., number of units, test runs, or participants) for any of the non-clinical tests (software, delivery accuracy, usability, EMC, functional/electrical safety, human factors).
• Data Provenance: The study was conducted by B. Braun Medical Inc. as part of its regulatory submission. The document doesn't explicitly state the country of origin but implies it's related to the U.S. FDA submission. It is a prospective study in the sense that testing was conducted specifically for this submission to verify and validate the device.

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

This information is not provided in the document. For device performance testing of an infusion pump, "ground truth" would typically refer to established engineering specifications, validated test methods, and industry standards, rather than expert consensus on individual cases. The human factors study involved "intended user population" but the number or specific qualifications of these users aren't detailed, nor are they "experts establishing ground truth" in the diagnostic sense.

4. Adjudication method for the test set:

This concept is not applicable to the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretations (e.g., medical image reading) where multiple experts assess the same cases and a consensus or tie-breaking mechanism is needed. The testing for an infusion pump device focuses on objective performance against engineering specifications and functional requirements.

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:

This is not applicable. The device is an infusion pump, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study or assessment of AI's effect on human reader performance was not conducted.

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

The document describes performance testing of the device itself, including its software. While the device contains software/algorithms, the performance testing described is of the integrated system, and not an "algorithm only" in the sense of a diagnostic AI standalone study. The device is intended to be used by "trained healthcare professionals," implying a human-in-the-loop operation, but the performance testing focuses on the device's inherent functional capabilities.

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

For the non-clinical and simulated clinical use testing, the "ground truth" would be established by:

• Engineering specifications and design requirements.
• Industry standards and regulatory guidelines (e.g., for safety, EMC).
• Pre-defined pass/fail criteria for various functional tests (e.g., delivery accuracy within a specified tolerance).
• User requirements for human factors studies (i.e., successful completion of tasks by intended users).

There is no mention of expert consensus, pathology, or outcomes data as ground truth for this device's performance evaluation.

8. The sample size for the training set:

This is not applicable. The Infusomat® Space Volumetric Infusion Pump System is not an AI/machine learning model in the sense that it requires a "training set" to learn from data for a diagnostic or predictive task. It is a medical device with pre-programmed functionality. The "Drug Library Manager" creates "drug libraries," which are configuration data, not training data for an algorithm.

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

This is not applicable for the same reasons as #8. There is no "training set" for this type of device.

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