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The Plum Duo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous.

The Plum Duo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.

The Plum Duo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

The Plum Duo™ Precision IV Pump is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient from 1 to 4 lines independently. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in ease of programming. The Plum Duo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). Each pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. Each pump channel cassette has an independent downstream line (patient line), so the clinician can connect each downstream line to a single infusion site or two separate infusion sites. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.

The provided FDA 510(k) clearance letter and summary for the Plum Duo™ Precision IV Pump discuss the device's technical specifications and how it meets regulatory requirements for significant equivalence to a predicate device. However, this document does not describe the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as implied by the user's detailed request.

The Plum Duo™ Precision IV Pump is an infusion pump, a hardware medical device with embedded software, not an AI/ML diagnostic or prognostic tool. Therefore, the requested information (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) does not apply to this specific device or the information provided in the 510(k) summary.

The 510(k) summary focuses on "Non-Clinical Testing" which includes:

• Verification testing of product requirements
• Human factors validation testing
• Reliability goals testing
• Safety assurance case following FDA Guidance for Infusion Pumps
• Flow rate and bolus accuracy testing per AAMI TIR101
• Software verification and validation per relevant FDA guidance documents (2005 and 2021 draft for software functions), which are focused on traditional software engineering principles, not AI/ML model performance.
• Human factors evaluations per FDA guidance and IEC 62366-1
• Electrical and Electromagnetic Compatibility testing per IEC 60601-1 and IEC 60601-1-2
• Cybersecurity testing per FDA guidance documents (2014 and 2016)
• Risk management activities per ISO 14971:2019 +A11 2021

Conclusion based on the provided document:

The provided document does not contain the information required to answer the specific questions about acceptance criteria and study proving an AI/ML device meets them. The device described, the Plum Duo™ Precision IV Pump, is an infusion pump, and its clearance relies on non-clinical performance and safety data relevant to its mechanical and software functions, not AI/ML-driven insights or diagnostics.

Therefore, I cannot populate the table or answer the specific questions regarding AI/ML study design and ground truth establishment for this device based on the given text. The text explicitly states: "Clinical evaluation is not required for this submission to support substantial equivalence." This further indicates that the type of studies and data provenance you are asking about (which are typical for AI/ML diagnostic devices) were not part of this 510(k) submission.

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