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The intended use of the new device is subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours.

This infusion set is intended for the administration of medicine, including insulin, from a portable, external pump to a subcutaneous infusion site, for up to 48 hours. The infusion set is designed to be used in conjunction with a MiniMed infusion pump, but may be used in other pumps capable of supporting a Luer connection to a reservoir; however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other devices.

Device materials have been successfully tested for biocompatibility. All components having contact with solutions being administered meet the ISO 10993 standard for medical devices of this type.

This document does not contain the information required to answer the request. The provided text is a 510(k) summary for an infusion set from 1996, which focuses on device description, intended use, and comparison to predicate devices, typical for regulatory submissions of that era. It does not include details about clinical studies, acceptance criteria, or performance data in the structured format requested.

Specifically, the following information is not present in the document:

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

The document states that "Device materials have been successfully tested for biocompatibility. All components having contact with solutions being administered meet the ISO 10993 standard for medical devices of this type." This refers to material testing, not a clinical performance study with defined acceptance criteria and statistical analysis as typically understood in the context of device performance.

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