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The InPen System is a home-use reusable pen for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen Smart Insulin pen allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For an insulin dose based on fixed/variable meal sizes, a healthcare provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use.

The InPen App is a software application with versions that are compatible with mobile phones running the iOS or Android operating system. The App is a component of the InPen system and is used with the InPen Smart Insulin pen for the management of insulin-requiring diabetes. The InPen App communicates with the InPen Smart Insulin pen to communicate doses that are delivered by the user. The InPen App is also compatible for use with blood glucose (BG) meters, Medtronic Continuous Glucose Monitors (CGMs), and the Dexcom CGMs. The InPen App includes a dose calculator that can calculate and recommend a dose for the user to review and consider as part of following the treatment plan prescribed by the healthcare provider. The dose calculator features in the App require that a healthcare professional provide patient-specific values for various therapy settings for programming into the App prior to use by the patient. These therapy settings include glucose target(s), duration of insulin action time, insulin sensitivity factor(s), and insulin-to-carbohydrate ratio(s) or fixed insulin doses for meal types and sizes. The dose calculator feature is unavailable to the user until these patient-specific values, provided by the healthcare professional, are programmed and an InPen has been paired to the App. A healthcare provider may also provide long-acting insulin settings to be programmed into the InPen App. The App includes a logbook feature that displays the patient's recent activity related to BG values, meal types and sizes, dose calculations, doses by insulin type (rapid- or long-acting), cartridge replacement and priming. The App also provides reminders and alerts that can notify the user to check their glucose, dose insulin (for potential missed meals, correction doses, and longacting insulin doses) and log doses according to schedule, replace a cartridge, or if the insulin pen has been exposed to very low or very high temperatures. The App can generate a supplemental summary report of recent therapy information for review by the patient or healthcare professional (HCP).

The InPen Cloud includes a therapy report component that the user and the health care provider (HCP) can view and print to assess the overall diabetes control and treatment plan. The report displays data based upon user and HCP-defined inputs, such as glucose, insulin and carb trended information, during the defined period, as well as dose calculator usage and alerts and reminders. The Insulin Notification Service (INS) is a subcomponent of the InPen Cloud that can receive Medtronic CGM sensor glucose measurements from the CareLink Cloud. The INS includes two algorithms that assess "real time" sensor glucose measurements to identify whether a user has missed a dose or if their glucose is rising and a correction dose is needed. If either of these conditions exist, a silent notification is sent by the INS to the InPen App. The InPen App confirms the data and can provide and visual alert to the user. The user can act on the alert by assessing their glucose levels followed by calculating a dose utilizing the InPen App dose calculator.

The provided text is a 510(k) summary for the Medtronic MiniMed InPen System. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not contain the specific details about acceptance criteria, the study design (including sample size, data provenance, expert ground truth establishment, or adjudication methods), or performance data in the way requested in the prompt.

The "Performance Data" section (Page 10) broadly states that "Software verification and validation testing was performed in accordance with the FDA's Guidance..." and mentions "unit level testing, integration level testing, and systems testing." It also notes "Cybersecurity Testing" and "risk management activities." Finally, it mentions an "additional assessment of the changes to the InPen Cloud occurred through a summative usability evaluation" where "patients...used the InPen Cloud to perform a series of critical tasks involving the use of the InPen App and Cloud, including the additional alerts and reminder."

Therefore, it is not possible to fill in most of the requested information based on the provided text. The document focuses on regulatory arguments for substantial equivalence rather than detailed clinical or technical study results that would typically include such specifics.

Here's a breakdown of what can be extracted and what cannot:

Information that CANNOT be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This detail is not present. The document focuses on showing the device is substantially equivalent to a predicate, not on specific performance metrics against pre-defined acceptance criteria.
2. Sample sizes used for the test set and the data provenance: No specific sample sizes for particular tests (e.g., test sets for algorithms) are mentioned, nor is the data provenance (country, retrospective/prospective). The "summative usability evaluation" is mentioned, but without sample size or details about the data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
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 mentioned. This type of study is more common for diagnostic imaging AI, whereas this device is an insulin management system with a dose calculator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the InPen App has an algorithm for dose calculation and the InPen Cloud has algorithms for notifications, the document doesn't provide performance data for these algorithms in isolation. The "summative usability evaluation" implies human-in-the-loop testing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated how the accuracy of the dose calculations or alert effectiveness was verified as "ground truth." The "summative usability evaluation" likely involved checking if users performed tasks correctly, but the underlying ground truth for algorithm accuracy isn't detailed.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Information that CAN be extracted or inferred from the provided text:

• Device Type: Insulin management system (reusable pen, app with dose calculator).
• Regulatory Class: Class II (Product Code: NDC).
• Software Level of Concern: Major.
• Key Software Features: Dose calculator (insulin dose based on carbohydrates or fixed/variable meal sizes), logging, reminders, alerts (missed dose, high glucose).
• New Features (compared to predicate):
  • Two new algorithms in the InPen Cloud (Insulin Notification Service) to identify and send "silent notifications" to the InPen App for missed insulin doses or rising glucose.
  • Two new visual and audible alerts in the InPen App for missed insulin doses or high glucose, for users with a Medtronic CGM.
  • Improved existing Long-Acting Reminder to include both audible and visual alerts.
• Performance Data (General Statement): "Software verification and validation testing was performed in accordance with the FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions'', and FDA's guidance "General Principles of Software Validation". Verification and validation activities included software testing consisting of unit level testing, integration level testing, and systems testing of the InPen App and InPen Cloud. Cybersecurity Testing was performed... Risk management activities... were undertaken... Additional assessment of the changes to the InPen Cloud occurred through a summative usability evaluation."

In summary, the provided document is a regulatory submission focused on substantial equivalence, not a detailed technical report of study results with specific performance metrics and study methodologies.

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