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The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature.

The COLLEAGUE DL2 Event History Download Software Application is a proprietary, Personal Computer (PC) based software accessory. It provides access to event history information from all product codes of the COLLEAGUE Volumetric Infusion Pump, which can then be downloaded. viewed, printed and copied to the Windows Clipboard for pasting into other programs

The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This feature is a clinical support tool that allows the clinician to compare pump programming with hospital-defined guidelines at the point of care. If the clinician programs any values outside of the rule sets established by the hospital, an out-of-limits warning occurs. These Configurations, including Personality Feature Sets and associated Labels, can be transferred to or from a COLLEAGUE pump. In addition, the Configurations may be saved in a COLLEAGUE GUARDIAN Configuration Tool file, allowing the use of this tool to create and update Configurations. The tool also allows confirmation of new or modified Configurations, copying of Configurations and printing of Configuration reports. The COLLEAGUE GUARDIAN Configuration Tool, as compared to manual entry, minimizes the potential to transcribe the wrong data value from paper documents.

All COLLEAGUE Volumetric Infusion Pumps have an Event History that stores the most recent 1,000 sequential pump events, such as key presses, alarms and alerts. The COLLEAGUE DL2 Event History Download Software Application facilitates the Event History download to a PC. These events may be viewed, printed and copied to the Windows Clipboard for pasting into other programs.

The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature.

The COLLEAGUE DL2 Event History Download Software Application is a proprietary, Personal Computer (PC) based software accessory. It provides access to event history information from all product codes of the COLLEAGUE Volumetric Infusion Pump, which can then be downloaded, viewed, printed and copied to the Windows Clipboard for pasting into other programs.

The provided text describes two software accessories for the COLLEAGUE Volumetric Infusion Pump: the COLLEAGUE GUARDIAN Configuration Tool and the COLLEAGUE DL2 Event History Download Software Application.

The document indicates "Non-clinical testing associated with intended use claims was performed according to the Baxter Healthcare Corporation Product Development Process." and that "The proposed COLLEAGUE GUARDIAN Configuration Tool and the COLLEAGUE DL2 Event History Download Software Application have been verified against product design requirements and validated against defined user needs/intended uses and instructions for use." However, it does not provide specific acceptance criteria or detailed study results in terms of numerical performance metrics. It concludes that the devices "are safe and effective in their use with the COLLEAGUE Volumetric Infusion Pump, and perform as well as or better than their predicates."

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Not explicitly stated in numerical terms. The general criterion is that the software accessories are "safe and effective" and "perform as well as or better than their predicates."	Verified against product design requirements.
   	Validated against defined user needs/intended uses and instructions for use.
   	Minimizes the potential to transcribe wrong data values from paper documents (for Configuration Tool).
   	Provides access, download, viewing, printing, and copying of event history (for DL2 Software).

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing is described as "Non-clinical testing."

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

   • Not specified. The document mentions "defined user needs/intended uses," suggesting input from stakeholders, but no details on expert involvement or qualifications for ground truth establishment.

4. Adjudication method for the test set

   • Not specified.

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

   • Not applicable. These are software accessories for an infusion pump, facilitating configuration and data download, not AI software for interpretation tasks typically associated with MRMC studies.

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

   • The testing described is "Non-clinical testing" and involves verification against design requirements and validation against user needs/intended uses. Given the nature of the software (configuration and data download tools), this implicitly represents standalone algorithm performance in executing its defined functions. However, a formal "standalone study" with detailed metrics is not described.

7. The type of ground truth used

   • The "ground truth" for these types of software accessories would typically be the correct execution of their programmed functions and accurate transfer/storage of data, as defined by "product design requirements" and "user needs/intended uses." It's not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic or predictive devices.

8. The sample size for the training set

   • Not applicable. These are software accessories, not machine learning algorithms that typically require training sets. They are rule-based or function-based software tools.

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

   • Not applicable, as there is no mention of a training set or machine learning components.

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