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Baxter Colleague Infusion Pumps are designed to meet the fluid delivery requirements of clinically acceptable routes of administration in a variety of clinical environments. These pumps can be utilized for continuous or intermittent delivery of solutions and or irrigation of fluid spaces applications.

Fluid delivery applications include:

• parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, analgesics, or chemotherapy);
• solutions for irrigation procedures, etc.; and
• whole blood and blood products.

Colleague Infusion Pumps are designed to travel the continuum of care, following the patient into a variety of care areas, including, but not limited to:

• A Hospital:
  • General Floor
  • · Medical/Surgical
  • · Critical/Intensive Care Areas
  • · Pediatrics/Neonatal
  • · Labor/Delivery/Post Partum
  • · OR/Anesthesia
• · Post Anesthesia/Recovery · P
• Cardiac Cath Lab
• · Emergency Room
• · Burn/Trauma Units
• Mobile Intensive Care A Nursing Homes A
  • Homecare* A

· Oncology

• *Colleague and Colleague CX pumps only.
• Blood Centers
• Nuclear Medicine A
• Hospice A
• Subacute Facilities A
• Outpatient/Surgical Centers A
• Long Term Care A

Colleague pumps use a shuttle and valve control system mechanism to provide accurate, continuous infusions. Colleague provides continuous infusion and combined modes of operation. The pumps have configurable input parameters, which allow institutions to pre-select which modes of operation will be available to users and which units of measure will be used for data entry. Baxter Healthcare proposes to modify the Colleague family of infusion pumps with the addition of new software features to expand the Colleague Guardian feature and to further enhance the safety of the device.

The provided text is a 510(k) summary for an infusion pump, which discusses its intended use, device description, and comparison to predicate devices, along with an FDA clearance letter. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report proving device effectiveness.

The document specifically states under the "Performance Data" section: "The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices." However, it does not provide the actual performance data or the specific requirements (acceptance criteria) that were met.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided text. The requested information regarding a table of acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth information is not present in the provided 510(k) summary.

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