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Device Specific Reports provide the user information compiled from data generated by networked devices and stored in the PharmGuard Server. This information may be used to support continuous quality improvement programs. Reports generated from the data can be used to analyze and trend various aspects of the designated infusion pump systems and therapies used.

The Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0 software is a medical device intended to be used in the analysis of infusion data, provide information used in forming clinical workflow decisions and improve infusion safety. The Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0 is an infusion pump accessory compatible with the PharmGuard® Server, which stores data exported from networked infusion pumps. The Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0 copies data from the PharmGuard® Server databases and uses it to create reports.

The Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0 can be used for transferring, displaying or storing and retrieving historical clinical data, clinical and operational alarm events, fault events, power events, maintenance events, therapy and therapy change events and telemetry events that are generated by the networked infusion pumps and stored in the PharmGuard® Server. It is also intended for near real-time monitoring of infusion pump history. For the purposes of this device "near real-time" is associated with time intervals typically measured in minutes rather than in seconds or in hours.

The Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0 manipulates and re-configures data to present information bevond the discrete data that is displayed on the pumps.

Reports include information on drug compliance, safety events, alarm history, drug program utilization, and pump technical status. Reports can summarize data and reveal trends in these areas by presenting results summarized by such parameters as time of day, facility, drug profile, alarm type and safety events. The information may be presented graphically, in table form and in some cases allows "drill through" to the underlying data used to produce the reports.

The Device Specific Reports Software comprises:

• . Instructions for Use and Help Files
• An executable file for launching the application .
• A Configuration Tool that provides a user interface to enter, update, and apply the . configuration parameters that operate the Data Mart associated with the Medfusion 4000® Device Specific Reports and associated SQL Server databases
• Metadata that is imported into the PharmGuard® Server System and that . determines what information within the PharmGuard® Server is available to be output via the Device Specific Report software
• Infrastructure files that interact to facilitate and coordinate the data acquisition, . storage, and processing between the PharmGuard® Repository and the Medfusion® 4000 Pump Device Specific Report data mart. The Reporting Infrastructure performs the following major tasks:
  • o Extract, Transform, and Load (ETL) data from the PharmGuard Repository into the Reporting Infrastructure data mart.
  • o Store device event data in the data mart
  • Process requests for data retrieval for device specific reports 0

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information. The document is a 510(k) summary for the Smiths Medical Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0.

Here's what the document does state regarding performance and studies:

• Performance Testing: "Smiths Medical performed software validation testing on the Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0."
• Testing Conclusion: "All testing met pre-established specifications, and successfully demonstrated that the device performed as intended."
• Clinical Studies: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Medfusion® 4000 Pump Device Specific Reports Software, Version 2.0."
• Equivalence: The device was found substantially equivalent to a predicate device (K111386, Medfusion® Model 4000 Series Syringe Infusion Pump, PharmGuard® Toolbox 2.0 Medication Safety Software).

However, the document does not contain any specific details regarding:

• The actual "pre-established specifications" that served as acceptance criteria.
• The quantitative results of the "software validation testing" to show how the device performed against those criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, adjudication methods, or ground truth types.
• Any multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor any of the other detailed study information, as these specifics are not present in the provided 510(k) summary.

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