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HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).

The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection 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.

Here's an analysis of the provided text regarding the HumaPen Luxura device, focusing on acceptance criteria and supporting studies:

This document is a 510(k) Premarket Notification from the FDA for the HumaPen Luxura, a reusable insulin pen. It primarily demonstrates substantial equivalence to a predicate device (HumaPen Luxura HD) rather than presenting a comprehensive study of a novel AI-powered device. Therefore, many of the requested categories for AI-specific studies and performance metrics are not applicable or cannot be extracted from this type of document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the specific number of devices or test cycles used for each non-clinical performance test. It mentions "sample devices" for the life-cycle test without giving a number.
• Data Provenance: The data is generated from non-clinical performance testing conducted by the device manufacturer, Eli Lilly and Company. This is prospective testing related to device design and manufacturing, not clinical data from patients. The country of origin of the data is implied to be within the company's testing facilities, likely in the US (Indianapolis, IN, is the submitter's location).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The referenced standards (ISO 11608-1:2012, ISO 10993-1:2009) define objective, quantifiable performance metrics, not expert-derived ground truth. Human Factors testing would involve users, but the document does not specify experts for "ground truth" establishment in the sense of AI evaluation.

4. Adjudication method for the test set:

Not applicable. The tests involve objective measurements against predefined criteria in international standards. There is no mention of an adjudication process for subjective assessments.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a mechanical insulin pen and not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical performance tests is the defined limits and methodologies within the referenced international standards (ISO 11608-1:2012 for dose accuracy and functionality, ISO 10993-1:2009 for biocompatibility). These are objective, empirically verifiable standards.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this mechanical device.

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The HumaPen Luxura HD is a reusable pen injector designed for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

HumaPen Luxura HD 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 3.0 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).

The provided document is a 510(k) summary for the HumaPen Luxura HD, a pen-injector for insulin. It describes the device's characteristics and its equivalence to a predicate device but does not contain the detailed information requested regarding the study design, sample sizes, expert involvement, or specific performance metrics in table format, as typically found in clinical trial reports or detailed scientific studies.

However, I can extract the available information and highlight what is missing based on your request.

Acceptance Criteria and Device Performance (Based on available information)

Study Information Pertaining to Device Performance

1. Sample size used for the test set and the data provenance:

   • Not provided. The document states "HumaPen Luxura HD was tested per ISO 11608-1 for dose accuracy and functionality" and "HumaPen Luxura HD components were evaluated for biocompatibility per ISO 10993-1." However, it does not specify the number of devices or components tested, the number of dose deliveries, or the origin of any data used.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. For a mechanical device like an insulin pen, "ground truth" and expert consensus as typically seen in image analysis or diagnostic AI studies are not relevant in the same way. Performance is measured against engineering standards (like ISO 11608-1) and physical properties (like dose delivery).

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication is not typically used for testing mechanical device performance against engineering standards. The device's output (e.g., delivered dose) is directly measured.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a pen-injector, a mechanical medical device, not an AI-assisted diagnostic tool or an imaging system that involves human readers interpreting results. Therefore, an MRMC study is not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a mechanical pen-injector. The concept of an "algorithm only" or "human-in-the-loop" performance does not apply to this type of device. Its performance is measured based on its mechanical function of drug delivery.

6. The type of ground truth used:

   • For dose accuracy: Instrumental measurements against an established international standard (ISO 11608-1.2000). The "ground truth" is the physically measured dose delivered by the device compared to the dialed dose, assessed according to the specified tolerances in the standard.
   • For biocompatibility: Laboratory testing against established international standard (ISO 10993-1). The "ground truth" here is determined by the results of biocompatibility tests on the device materials.

7. The sample size for the training set:

   • Not applicable/Not provided. This is a mechanical device, not an AI model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth establishment process in that context.

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The HumaPen Luxura HD is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 1 to 30 units in one-half (1/2) unit increments.

HumaPen Luxura HD is a reusable mechanical pen-injector designed for the selfinjection 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 provided text does not contain information about acceptance criteria or a study proving that the HumaPen Luxura HD device meets acceptance criteria. The document is a 510(k) summary for a premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

To be able to answer your questions, I would need a section of the submission that details performance testing, including:

1. Acceptance Criteria Table: A table outlining the predefined performance targets the device needed to meet.
2. Study Results: Data showing how the device performed against those criteria.
3. Study Design Details: Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, and whether standalone or MRMC studies were conducted.

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