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HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL cartridges using disposable pen needles (sold separately).

The HumaPen Savvio is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.

The provided text describes the HumaPen Savvio, a reusable insulin pen-injector, and its evaluation for substantial equivalence to a predicate device. However, the text does not contain information related to an AI/ML powered device, an acceptance criteria table with reported device performance, sample sizes for test sets (in the context of AI/ML evaluation), data provenance, the number and qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type and establishment of ground truth for training or test sets.

The document is a traditional 510(k) summary for a mechanical medical device, focusing on engineering and human factors testing against established international standards for pen-injectors (ISO 11608-1:2014) and biocompatibility (ISO 10993-1:2009).

Therefore, I cannot provide the requested information. The text clearly states that "No clinical tests were performed" and the evaluation is based on non-clinical performance data (engineering testing) and human factors testing to assess usability differences from the predicate device.

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