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The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (iCGM) and an interoperable automated glycemic controller (iAGC), in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump is intended for single-person use; it is not to be shared.

The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (iCGM) and an interoperable automated glycemic controller (iAGC) in people 6 years of age or older with diabetes mellitus.

The iLet ACE Pump provides a graphical user interface and alerts to interact with the iLet delivery system and an iAGC.

The iLet Bionic Pancreas System is a collection of wearable medical devices that work together to deliver insulin with minimal user oversight. The iLet System is made up of the iLet bionic pancreas (consisting of the iLet ACE Pump (with accessories) and iAGC which may reside on the ACE pump hardware), ACE pump disposables and accessories, iCGM and infusion set. The insulin is filled for iLet use by a user, in a ready-to-fill cartridge (from an insulin vial supplied by a drug manufacturer) with the use of the syringe and needle.

The iLet ACE Pump includes a motor-drivetrain pumping mechanism, which independently actuates the delivery of insulin from a cartridge that is separately loaded into the iLet. Insulin is injected under the skin via continuous infusion.

The iLet ACE Pump has a wirelessly rechargeable battery and is designed to be used by a single person and have a useful life of at least 4 years. The iLet is charged on a wireless charging pad which comes with the device. The Luer connector and drug cartridge need to be changed every 3 days. The insulin infusion set (including tubing and base) needs to be changed every 2-3 days for infusion sets with a teflon cannula (Convatec Inset™ and Inset™ 30) and every 1-2 days for infusion sets with a steel cannula (Convatec Contact™ Detach) as indicated in the infusion set manufacturers' labeling. The iCGM sensor needs to be changed every 10 days.

The provided text does not describe the acceptance criteria and study that proves the device meets those criteria for an AI/ML powered device. The document pertains to the FDA clearance of the iLet ACE Pump, which is an alternate controller enabled infusion pump for insulin delivery. While it mentions the pump receives input from an integrated continuous glucose monitor (iCGM) and an interoperable automated glycemic controller (iAGC), and that the iAGC uses this information to calculate insulin needs, it does not describe an AI/ML algorithm that is being evaluated for its diagnostic or prognostic performance.

Therefore, I cannot extract the specific information requested in your bullet points related to AI/ML acceptance criteria and performance studies, such as:

• A table of acceptance criteria and reported device performance (for an AI/ML algorithm)
• Sample size used for the test set and data provenance (for AI/ML evaluation)
• Number of experts used to establish ground truth and their qualifications (for AI/ML annotation)
• Adjudication method (for AI/ML ground truth)
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size (for AI/ML assistance)
• Standalone performance (algorithm only without human-in-the-loop performance)
• Type of ground truth used (for AI/ML)
• Sample size for the training set (for AI/ML)
• How ground truth for the training set was established (for AI/ML)

Instead, the document focuses on the regulatory clearance process for a medical device (insulin pump) and typically discusses:

• Non-clinical performance data: This includes bench testing for dose delivery accuracy, occlusion detection, biocompatibility, sterility, electrical safety, EMC, CGM connectivity, packaging, shipping, and mechanical tests. All tests passed.
• Data logging and Interoperability: The device was validated for logging timestamped events and interoperability with connected devices.
• Cybersecurity: Mitigations for cybersecurity risks were incorporated, and an analysis was performed.
• Human Factors: A human factors validation study was conducted in a simulated use condition, including training and documentation, and demonstrated the system's safety and effectiveness for intended users and uses.
• Clinical Performance: A clinical study was not required for the iLet ACE Pump, as insulin delivery could be verified through bench testing and use validated through the human factors study.

The closest thing to "acceptance criteria" presented are the successful completion of these various non-clinical and human factors tests, indicating the device meets its design specifications and regulatory requirements for safety and effectiveness, similar to its predicate device.

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