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The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The CeQur Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.

The provided text is a 510(k) summary for the CeQur Simplicity™ On-Demand Insulin Delivery System. It describes the device, its intended use, and states that performance data demonstrates its safety and effectiveness. However, the document does not contain specific acceptance criteria, reported device performance metrics in tabular form, details of a study with sample sizes, expert qualifications, or adjudication methods.

The 510(k) summary states generalized information such as "The performance data reported in this 510(k) demonstrate that the proposed device modifications do not raise different questions of safety and effectiveness than those for the predicate device is as safe and effective as the predicate device." but lacks the detailed information requested in the prompt.

Therefore, I cannot provide the requested information from the given text. The text does not detail:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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