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The Animas Model IR 1200 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. This device is intended for home use and is a prescription device.

The Animas Model IR 1200 Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model IR 1200 is used with an infusion set, e.g., the Animas ezSet™ The pump incorporates serial communications via an infrared (IR) interface. The user may download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and Pump Settings. The pump is intended for multiple years of use and the insulin syringe is a sterile, single use disposable manufactured for Animas. The system will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

The provided text is a 510(k) summary for the Animas Model IR 1200 Insulin Infusion Pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training set was established.

The document primarily focuses on establishing substantial equivalence based on design, materials, and construction, rather than detailed performance study results against specific criteria. The statement in Section 1 "The differences between the new device and the predicate device do not affect the safety or effectiveness of the device" is a high-level assertion but not supported by detailed study data in this document.

Therefore, I cannot fulfill your request for this specific information based on the provided input. The document does not contain the necessary details to construct the requested table and answer the study-related questions.

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