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InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.

InfuLife is a non-electrically driven, portable fixed flow rate infusion pump. The fluid is pushed forward by the pressure of the elastomeric bladder. The flow rate of the device is predetermined by the manufacturer using Hagen-Poiseuille theory, which calculates the volumetric flow rate of a fluid with certain viscosity passing through a cylindrical pipe with a known diameter, at a given pressure and temperature.

The provided text describes InfuLife, an elastomeric infusion pump, and its 510(k) submission for FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device and outlines performance testing against various standards. However, it does NOT contain the specific information requested regarding AI/algorithm performance studies, ground truth establishment, or multi-reader multi-case (MRMC) studies, as this device appears to be a hardware-based medical device (infusion pump) and not an AI/software-as-a-medical-device (SaMD).

Therefore, I cannot provide the requested information about acceptance criteria for an AI algorithm, its performance, or details of studies involving human readers and AI assistance, as these are not relevant to the InfuLife device described.

The document explicitly states:

• "No animal study or clinical trial data was obtained in support of this submission." (Page 10)
• The performance data refers to testing against engineering and biological safety standards (e.g., flow rate accuracy, biocompatibility, sterilization, shelf-life, packaging integrity) for a physical medical device. (Page 9)

If you have a document describing an AI/SaMD, please provide that.

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