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

The Perfusor® Space Syringe Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities and for medical ground and/or air transport situations.

The Perfusor® Space Syringe Infusion Pump System includes an external, transportable, electronic infusion pump and pump accessories.

The Perfusor® Space Syringe Infusion Pump utilizes a swivel drive pumping mechanism and operates on a 12V DC power source that can be provided from a battery or through external sources such as a power supply connected to a 120V AC wall outlet.

The front panel of the Perfusor® Space Pump includes a backlit graphical display, a backlit keypad with 10 push buttons including directional arrows to navigate through menu items and indicator lamps to alert the clinician to critical conditions.

The Perfusor® Space Syringe Infusion Pump is capable of wireless communication both inbound and outbound. Autoprogramming of the pump is possible where the pump receives infusion parameters wirelessly from the electronic health record over the hospital Wireless Local Access Network.

The B. Braun Space Station is a flexible docking and communication system designed to accommodate multiple Perfusor® Space Syringe Infusion Pumps for use in a medical facility.

Space Com is a communication device that has been integrated into the 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. 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. Features like barcoding and wireless data transmission are enabled when a Perfusor® Space Pump is housed within a SpaceStation with Space Com. The outbound data communication through Space Com transfers status data of the infusion pumps to a hospital server.

Space OnlineSuite is a server based software system which provides the following applications:

Space Server Core is the basic server framework for Space application framework provides basic server functions like User Management, License Management, Communication Service, Security and Maintenance Functions. These functions are used by the administrator of the Space OnlineSuite. Drug Library Manager and Upload Manager applications also use the basic functions of SpaceServer Core.

Drug Library Manager is used to create and administer a drug library which can be used in the Perfusor® Space Syringe Infusion Pump. These features are designed to enhance medication safety and reduce medication errors.

Upload Manager can be used to manage the upload of drug libraries to any single B. Braun Space infusion pump, multiple Space pumps within a facility or to all Space pumps on the System. The drug libraries will be uploaded to SpaceCom (within SpaceStation) and then transferred via CAN bus (Controller Area Network) to the pumps or to a single Perfusor® Space Syringe Infusion Pump directly.

The provided text is related to a 510(k) premarket notification for the Perfusor® Space Syringe Infusion Pump System. It describes the device, its intended use, a comparison with predicate devices, and performance testing conducted. However, the text does not contain any information about an AI/algorithm-based medical device study.

Therefore, I cannot fulfill the request to describe acceptance criteria and study proving a device meets acceptance criteria using an AI model. The provided document is about a mechanical-electronic infusion pump, not an AI-driven diagnostic or therapeutic device.

To directly address the prompt, based on the provided text, the following information is not available:

1. Table of acceptance criteria and reported device performance (for an AI model): Not applicable as this is not an AI device.
2. Sample size used for the test set and data provenance (for an AI model): Not applicable.
3. Number of experts used to establish ground truth and qualifications (for an AI model): Not applicable.
4. Adjudication method (for an AI model): Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study (for an AI model): Not applicable.
6. Standalone (algorithm only) performance (for an AI model): Not applicable.
7. Type of ground truth used (for an AI model): Not applicable.
8. Sample size for the training set (for an AI model): Not applicable.
9. How ground truth for the training set was established (for an AI model): Not applicable.

The document details engineering and performance testing for a medical pump, such as:

• Software verification and validation per FDA Guidance for Medical Devices.
• Cybersecurity evaluation per FDA Guidance.
• System verification and validation for pump and Space Station functionality.
• Electrical Safety (IEC 60601-1), EMC Testing (IEC 60601-1-2), and Essential Performance testing (IEC 60601-2-24: 2012). Essential performance attributes include:
  • Infusion of liquids without variation of infusion rate.
  • Pressure limitation as protection from the bursting of the infusion line.
  • Protection against unintended bolus volumes and occlusion.
  • Alarm signal of high priority.
• Electromagnetic Compatibility and Wireless testing per relevant FDA guidance and IEC standards.
• Li-ion and NiMH battery safety per IEC 62133.
• Reprocessing validation per FDA Guidance.
• Human factors studies conducted with intended users, environment, and scenarios to validate device per intended use.

The document explicitly states: "No clinical testing was performed as the Perfusor® Space Syringe Pump System does not require clinical studies to demonstrate substantial equivalence with the predicate device." This further confirms that no studies involving human interpretation of data for AI model evaluation were conducted or are relevant to this submission.

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