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The Abbott LifeCare® PCA 3 Infuser is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient demanded (PCA) intravenous administration. The Abbott LifeCare® PCA 3 Infuser is also indicated for short-term continuous (less than 96 hours) administration of analgesic drugs.

The Abbott LifeCare® PCA 3 Infuser is indicated for volumetric infusion of analgesic drugs by continuous or patient demanded (PCA) intravenous administration. The Abbott LifeCare® PCA 3 Infuser is also indicated for short-term continuous (less than 96 hours) epidural administration of analgesic drugs.

The Abbott LifeCare® PCA 3 Infuser is a pole-mounted infusion pump that allows a patient to self-administer analgesia within physician programmed limits. Generally, a nurse programs the infuser with operating parameters which may include the following:

• Loading Dose
• Delivery Mode Setting, i.e., PCA, Continuous, or PCA+ Continuous
• PCA Dose
• Lockout Interval
• Rate of Continuous Flow
• 1 or 4 hour Dose Limit (factory setting at 4 hours)
• Stored Protocols (Hospital configured settings for both filled and custom vials)

The modifications in this submission consist of an update to a prior model including software revisions, an improved user interface, adding a bar code reader for drug identification and the incorporation of upgraded electrical and mechanical components that help improve fault detection.

Other chanqes to the proposed device include an improved liquid crystal display, a new patient pendant and the labeling has been revised to incorporate each of the modifications.

The Abbott LifeCare® PCA 3 Infuser is programmed to recognize bar coded drug vials and halts further programming if this recognition is not achieved.

The proposed device is a microprocessor-based pump that incorporates an enhanced LCD display. Pump operation is identical to prior Abbot models through the utilization of a stepper motor that exerts pressure on the drug vial so that precise amounts of analgesic drug are delivered per the prescription.

The proposed device has the same intended use as the predicate device and uses the same dedicated administration sets and the same empty and pre-filled vials as the predicate device.

The provided text is a 510(k) summary for the Abbott LifeCare® PCA 3 Infuser (K022203). This document is a regulatory submission for a medical device and describes modifications to an existing device rather than a new standalone device. As such, the document does not contain the typical information about a study with acceptance criteria and reported device performance in the way one would expect for a novel AI/software medical device.

The submission focuses on demonstrating substantial equivalence to a predicate device by emphasizing that the changes do not raise new issues of safety and effectiveness. The "acceptance criteria" here are implied by the regulatory standard of "acceptable performance" of the device modifications.

Here's an analysis based on the provided text, acknowledging the limitations in the content for an AI/software-focused request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device." However, it does not provide specific, quantifiable acceptance criteria or detailed reported performance data for each modification.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). The testing mentioned is "nonclinical tests" for "functional performance of the proposed Abbott LifeCare® PCA 3 Infuser."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided. Given this is a hardware/software medical device submission focusing on functional changes, the "ground truth" would likely be established through engineering and quality assurance testing rather than expert clinical consensus in the way an AI diagnostic tool would require.

4. Adjudication Method for the Test Set:

This information is not applicable or provided.

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:

This type of study is not mentioned and is not relevant to this specific device submission. The device is an infusion pump, not an AI diagnostic or assistance tool in the context of "human readers."

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

The device (an infusion pump) inherently has a "human-in-the-loop" for programming and use. The "algorithm" in question relates to the pump's control software, including features like the bar code reader logic and user interface. While these algorithms would be tested standalone in terms of their functionality (e.g., does the barcode reader correctly identify or reject vials), the document does not separate "algorithm only" performance data from the overall device performance in the way typically discussed for AI/ML devices. The "functional performance" testing would encompass the algorithm's correct execution.

7. The Type of Ground Truth Used:

For the "nonclinical tests" of functional performance, the ground truth would be established by engineering specifications, validated test protocols, and simulated conditions to ensure the device operates as designed (e.g., infusion accuracy, alarm activation, barcode recognition rules). It would not typically involve expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set:

This is not applicable or provided. This is a traditional medical device submission, not an AI/ML device that requires a "training set" in the context of machine learning. The software revisions are presumably developed and tested using standard software development lifecycle methodologies.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no concept of a "training set" in this submission.

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