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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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HumaPen Ergo II 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 Ergo II 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 document is a 510(k) summary for the HumaPen Ergo II, a reusable insulin pen. It focuses on demonstrating substantial equivalence to a predicate device (HumaPen Luxura) based on non-clinical performance data.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The device (HumaPen Ergo II) meets the requirements of ISO 11608-1:2014 Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems. The document specifically outlines that the device passed dose accuracy requirements after preconditioning under various conditions defined in this standard.

2. Sample Size Used for the Test Set and Data Provenance

• Dose Accuracy & Environmental Testing: The document does not specify the exact sample size for the dose accuracy and environmental tests conducted according to ISO 11608-1:2014. The standard itself would dictate minimum sample sizes for such tests.
• Biocompatibility Testing: The document states that the exterior materials were "evaluated," but does not explicitly state the sample sizes of materials or animal subjects (if applicable) used.
• Human Factors Testing: The document does not specify the sample size for human factors testing.
• Data Provenance: The studies are non-clinical (laboratory/bench testing, material testing, human factors testing, presumably conducted by the manufacturer or contracted labs). The country of origin of the data is not specified, but given the submission to the US FDA by Eli Lilly and Company, Inc., it is reasonable to assume the studies were conducted to international standards accepted by the FDA. The data is prospective in the sense that the new device was tested against established standards to demonstrate performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international standards (ISO 11608-1:2014 and ISO 10993-1:2009) and the objective measurements derived from applying the test methods specified in these standards. Expert consensus would apply to clinical trials or diagnostic accuracy studies, which were not performed here.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical studies or image-based diagnostic assessments. The tests described are objective, quantitative measurements against specific criteria outlined in ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is an insulin pen, not an AI-powered diagnostic device or a system requiring human interpretation of medical images. No MRMC study or AI-assistance study was performed or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a mechanical pen-injector. There is no algorithm or AI component to evaluate in a standalone manner. The "standalone" performance here relates to the device's ability to precisely deliver insulin, which is covered by the dose accuracy testing per ISO 11608-1.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on:

• Objective measurements against established international standards: Specifically, the requirements and test methods detailed in ISO 11608-1:2014 for needle-based injection systems (for dose accuracy, life-cycle, environmental stability, etc.).
• Biocompatibility standards: ISO 10993-1:2009, which defines methods and criteria for evaluating biological responses to medical device materials.

These are considered objective, verifiable criteria rather than subjective expert consensus, pathology, or outcomes data in the traditional sense, as this is a non-clinical evaluation.

8. The Sample Size for the Training Set

This is not applicable. The HumaPen Ergo II is a mechanical device, not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithmic development. The design and manufacturing process would involve internal testing and validation, but not a training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for an AI/machine learning model. The "ground truth" for the device's design and manufacturing is established by engineering specifications, design verification, and validation against the relevant ISO standards to ensure the device performs as intended.

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