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The Hospira LifeCare® PCA3 Infusion System is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs.

The Hospira LifeCare® PCA3 Infusion System is a microprocessor controlled, pole mounted, standalone, electromechanical infusion pump that allows a patient to self administer, analgeric usines, a patient pendant, within physician prescribed, programmed parameters. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. The infuser will accept a pre-filled drug vial manufactured by Haspire and includes one sterile empty vial that can be filled by a hospital's pharmacy.

The provided text is a 510(k) summary for the Hospira LifeCare® PCA3 Infusion System. It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for testing or training sets, ground truth establishment, expert involvement, or MRMC studies.

The document states that the device "meets the functional claims and intended use as described in the product labeling" and that "The proposed modifications do not raise new issues of safety and/or effectiveness." It also makes claims of substantial equivalence based on:

1. Same intended use
2. Same indication for use
3. Same fundamental technology and operating principle
4. Same physical, operational, environmental and performance attributes
5. Same materials of construction for infuser components and administration sets

It lists "Performance Features" such as "Delivery Rates, Dose Units, Delivery Accuracy, Delivery Modes, Occlusion Pressure Limits, Alarm Types and Conditions" as being "Same" as the predicate devices, implying these are the performance criteria that were considered. However, explicit numerical acceptance criteria and the results of a study demonstrating these are not present in this summary.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

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