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The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application such as the myTempo App (App).

The Tempo Smart Button is indicated for single-patients 18 years or older who are:

• . diagnosed with type 1 or type 2 diabetes mellitus,
• using prefilled insulin Tempo Pens [Basaglar® Tempo Pen (insulin glargine) injection 100 units/mL, Lyumjev®
• Tempo Pen (insulin lispro-aabc) injection 100 units/mL, Humalog® Tempo Pen (insulin lispro injection) 100 units/mL],
• using a compatible application (App).

The Tempo Smart Button is a reusable data transmitter that detects and stores insulin doserelated data when attached to a disposable Tempo Pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology. The insulin dose-related data is used by the mobile application which can display the brand of insulin, dose amount, date, and time.

Additionally, the Tempo Smart Button is available as part of a Welcome Kit. The Tempo Welcome Kit and Refill Kit provide the convenience of having a single kit that contains devices needed for insulin administration and blood glucose monitoring.

The provided text does not contain specific acceptance criteria or a detailed study description for the Tempo Smart Button's performance related to its primary function of detecting, storing, and transferring insulin dose-related data. While general statements about meeting acceptance criteria and various tests are made, the specifics requested in your prompt are largely absent.

Here's an analysis of what information is available:

1. A table of acceptance criteria and the reported device performance:

The document broadly states:

• "Lilly completed module testing for general design requirements, mechanical characterization, and accuracy of electronic dose capture. In all instances, the module met the acceptance criteria."
• "Bench Testing: Testing confirms that the module does not impact Tempo Pen compliance to specifications for dialing torque, injection force, and dose accuracy, nor does it impact Tempo Pen compliance to ISO 11608-1."

However, specific numerical acceptance criteria (e.g., accuracy percentage, tolerance levels) and the corresponding reported performance values for "accuracy of electronic dose capture" or other key functions are not provided in the text.

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Bench Testing" and "module testing."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not specified.

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:

• This device is an "injection data capture device" and not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable or expected for this type of device.

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

• The device's core function is autonomous data capture and transfer. The statement "accuracy of electronic dose capture. In all instances, the module met the acceptance criteria" implies standalone performance testing was conducted for this functionality. However, detailed results are missing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the "accuracy of electronic dose capture," the ground truth would likely be the actual dose dialed on the pen, measured independently, or validated through mechanical means, rather than expert consensus or pathology. This is inferred from the bench testing context, but not explicitly stated.

8. The sample size for the training set:

• The document mentions "Software Verification and Validation" but does not refer to machine learning model training or a "training set" in the context of data used for algorithm development. This suggests the primary function is not based on a learnable AI model from a training set, but rather on direct electronic sensing and data processing.

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

• As a "training set" in the context of machine learning is not mentioned, this information is not applicable and hence not provided.

Summary of Available Information from the Provided Text:

The document confirms that the Tempo Smart Button underwent "Bench Testing" and "module testing for general design requirements, mechanical characterization, and accuracy of electronic dose capture," and "In all instances, the module met the acceptance criteria." It also states the device "does not impact Tempo Pen compliance to ISO 11608-1."

However, the specific quantitative acceptance criteria and the detailed results of these tests (e.g., specific accuracy rates for dose capture), along with the sample sizes, data provenance, and ground truth establishment methods for those specific performance aspects, are not disclosed in the provided FDA letter and 510(k) summary. The information focuses more on regulatory compliance (biocompatibility, electrical safety, software validation, cybersecurity) and substantial equivalence to a predicate device rather than in-depth performance study results for the core data capture function.

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The Go Dose System, comprised of the Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient. Go Dose Pro applications are not intended to replace the care provided by a licensed health care provider or to provide any diagnosis on patient blood glucose values. Go Dose Pro applications are for prescription use only.

Go Dose is for prescription use only by persons who are:

• Diagnosed with type 2 diabetes mellitus (DM)
• Aged 18-85 years
• Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
• Requiring treatment intensification with Humalog 100 units per mL (U-100)
• For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate

Go Dose should be used multiple times per day, as directed by your healthcare provider, for entering blood glucose values and getting Humalog dosing recommendations.

The Go Dose daily adjusted dosing algorithm was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

Go Dose Pro is intended for use by health care providers who have experience prescribing mealtime insulin, including providing direction to patients within the scope of a preplanned treatments to prescribed insulin. Health care providers should use the Go Dose Pro to aid in the review, analysis and evaluation of historical blood glucose test values to support diabetes management in patients that meet the following criteria:

• Diagnosed with type 2 diabetes mellitus (DM)
• Aged 18-85 years
• Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
• Requiring treatment intensification with Humalog 100 units per mL (U-100)
• For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate

The Go Dose design is based on a dosing algorithm that was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

The Go Dose System, comprised of Go Dose Pro mobile medical applications (apps), aids patients under the supervision of their health care provider (HCP) in the management of type 2 diabetes mellitus (T2DM).

This medical device system is based on a "paper-based" algorithm approach that was studied for safety and efficacy in 2 multinational, multicenter, randomized, open-label, parallel-group studies within a single clinical trial, F3Z-MC-IOQC (Trial IOQC) as described in Edelman et al. 2014. This study enrolled adult patients with T2DM who were not under glycemic control after optimizing the dose of insulin glargine for fasting blood glucose, with or without metformin. The medical device provides HCPs and patients with an evidence-based approach to initiate and titrate Humalog® 100 units/mL (insulin lispro) therapy for patients continuing insulin glargine, with or without metformin.

The HCP determines the meal selection for Humalog titration and the Go Dose Pro app, and sends the dose recommendation to the patient's Go Dose app. The patient uses the Go Dose app to view the initial dose recommendation. The Go Dose app uses blood glucose values manually entered by the patient as an input to determine ongoing individualized dose recommendations. This titration process continues until the HCP determines that the dose can be stabilized (i.e., no further titration required) or stopped (i.e., discontinue that dose). At that point, the HCP will determine whether to select a new meal for dose titration, stop any additional use of the Go Dose System, or select additional stable pre-meal dose(s).

The Go Dose System is a mobile medical application designed to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. It provides recommendations for titrating prandial Humalog dosing.

Here's an analysis of the acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't explicitly list a table of "acceptance criteria" against "reported device performance" for the Go Dose System as one might find for a hardware device's technical specifications (e.g., accuracy of a measurement). Instead, the submission relies on the historical clinical validation of the underlying algorithm and extensive software verification and validation.

The "acceptance criteria" are implied through the statement that "the predetermined acceptance criteria were met" during summative and supplemental validation studies (Page 11). The primary performance validation for the algorithm itself is derived from the "Trial IOQC" study. The device's performance, therefore, is directly linked to the outcomes of this clinical trial in terms of its ability to initiate and titrate prandial insulin lispro (Humalog) therapy and improve diabetes management.

Implied Acceptance Criteria (from the clinical study and device's purpose):

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

• Test Set Description: No specific "test set" for the device software is described with a distinct sample size in the context of the clinical trial. However, the clinical algorithm was tested in a large clinical trial.
• Sample Size for Algorithm Validation (Trial IOQC): The details state that Trial IOQC enrolled "adult patients with T2DM who were not under glycemic control after optimizing the dose of insulin glargine for fasting blood glucose, with or without metformin." While the exact number isn't provided in the excerpt, the paper referenced (Edelman et al. 2014) would contain this information. The description mentions "2 multinational, multicenter, randomized, open-label, parallel-group studies within a single clinical trial." This implies a substantial sample size.
• Data Provenance: "multinational, multicenter" indicates data from multiple countries and clinical sites. The studies were prospective as they were described as "randomized, open-label, parallel-group studies within a single clinical trial."

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

This information is not provided in the document. The "ground truth" for the algorithm was established through the clinical trial's outcomes, where patient blood glucose levels and insulin doses were collected and analyzed directly. There is no mention of a separate panel of experts establishing ground truth for the clinical algorithm retrospective evaluation against a "test set" in the traditional sense of an AI model's validation. The experts involved would be the clinical investigators and trial statisticians of the "Trial IOQC."

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the clinical trial (randomized, open-label, parallel-group), outcomes were likely adjudicated based on pre-defined clinical endpoints and statistical analysis rather than a consensus of experts retrospectively labeling data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for image-based diagnostic aids where multiple human readers interpret cases with and without AI assistance. The Go Dose System is an insulin dosing calculator, not an image interpretation tool. Its effectiveness is measured by clinical outcomes related to glycemic control.

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

Yes, the underlying algorithm's performance was evaluated in a standalone manner within the clinical trial. The "paper-based" algorithm, which is the foundation of the Go Dose System, was studied for safety and efficacy in "Trial IOQC" before being implemented in the mobile application. The mobile application then underwent software verification and validation, but the core clinical performance relied on the prior clinical validation of the algorithm itself.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation of the algorithm (Trial IOQC) was outcomes data, specifically:

• Blood glucose values (objective physiological measurements).
• Patient health status, including glycemic control.
• Insulin dosing regimens.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the algorithm in the context of machine learning. The algorithm's design is stated to be "based on a 'paper-based' algorithm approach that was studied for safety and efficacy in 2 multinational, multicenter, randomized, open-label, parallel-group studies within a single clinical trial, F3Z-MC-IOQC (Trial IOQC) as described in Edelman et al. 2014." This suggests a rule-based algorithm derived from established clinical evidence and refined through traditional clinical trials, rather than a data-driven machine learning approach requiring a distinct training set. The clinical trial itself serves as the validation of the algorithm's effectiveness.

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

Since it's a rule-based algorithm and not a machine learning model with a distinct "training set," the concept of "ground truth for the training set" doesn't directly apply in the same way. The algorithm's rules and parameters would have been established based on medical knowledge, clinical guidelines, and insights gained from extensive research and prior clinical experience with insulin titration, potentially informed by observational data or previous pilot studies, eventually validated in Trial IOQC. The efficacy and safety were then prospectively evaluated in the aforementioned clinical trial (Trial IOQC) against observed patient blood glucose values and clinical outcomes.

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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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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 Memoir 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 insulin (Humalog® and Humulin®) and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose in one-unit increments up to 60 units.

HumaPen Memoir is a reusable mechanical pen-injector with electronic display designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company Humalog and Humulin 3.0 mL cartridges and single-use, detachable and disposable pen needles (supplied separately).

The provided text is related to a 510(k) submission for a medical device called "HumaPen Memoir," which is a pen-injector for insulin. The information primarily focuses on describing the device, its intended use, and comparing its technological characteristics to a predicate device.

The document does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. The only mention of performance criteria is:

1. A table of acceptance criteria and the reported device performance:

The document states that the "Delivery accuracy meets ISO 11608-1.2000 requirements," but does not provide the specific metrics or values from a study that demonstrate this.

The remaining requested information is not available in the provided text:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not mentioned. This type of device (an insulin pen-injector) would typically not involve expert consensus for ground truth as an AI/software device would.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
• 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 relevant or mentioned for this type of device. The HumaPen Memoir is a mechanical pen-injector with an electronic display, not an AI-assisted diagnostic tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant or mentioned. This is a medical device for drug delivery, not an algorithm or AI.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For delivery accuracy, the ground truth would be based on metrological measurements against the ISO standard, not expert consensus or pathology. No specific details are provided beyond "Meets ISO 11608-1.2000 requirements."
• 8. The sample size for the training set: Not applicable for this type of mechanical device.
• 9. How the ground truth for the training set was established: Not applicable for this type of mechanical device.

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