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The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 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 injector 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 age 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 professional must 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 professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

The InPen System consists of a manually-controlled pen injector and an app containing a logbook and a dose (bolus) calculator.

The InPen is a manual pen injector containing a non-replaceable battery and electronics to communicate via Bluetooth® with the app on an iOS® mobile device. The intended dose is manually set by the user by rotating a dose knob. The insulin is injected by manually depressing the dose knob which causes the piston in the insulin cartridge to expel the intended dose. The InPen is provided in two different models for compatibility with the available U-100 insulin cartridges, i.e. Humalog®, Novolog®, and Fiasp®. The device is provided with Instructions For Use and a Quick Start Guide. The device is used with sterile needles and U-100 insulin cartridges (supplied separately).

The app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.

Here's a breakdown of the acceptance criteria and study information for the InPen System, based on the provided FDA 510(k) summary:

Important Note: The provided document is a 510(k) summary for a substantial equivalence determination. This means the device is being compared to a previously cleared predicate device (K190487). The performance data presented often focuses on demonstrating that the new device meets the same standards as the predicate and that any changes (like expanded indications for use) do not raise new questions of safety or effectiveness. It does not typically include detailed, de novo clinical trial results for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a numerical sample size for a "test set" in the context of an algorithm's performance evaluation.

• Provenance: The primary basis for comparison is a previously cleared predicate device (K190487). The "study" referenced for the current submission primarily relates to human factors evaluation and literature review to support the expanded indications (pediatric use). This suggests the data provenance is a combination of:
  • Previously established performance of the predicate device (likely from earlier submissions).
  • New human factors data (prospective) related to the pediatric use case.
  • Literature review (retrospective).

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

This information is not explicitly provided in the summary. Since the evaluation primarily relies on demonstrating substantial equivalence to a predicate and conducting human factors testing for expanded use, it's unlikely a separate "ground truth" establishment by a panel of experts, as might be done for an AI diagnostic device, occurred for this specific 510(k) submission. Human factors may involve usability experts, but their role is different from establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Given the nature of the device (insulin pen and dose calculator) and the type of evaluation described (human factors, substantial equivalence), an adjudication method for a "test set" in the context of expert review for diagnostic ground truth is not typically applicable or detailed in this type of submission.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned or explicitly described. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. The InPen system is an insulin delivery and dose calculation device, not a diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

While the device includes a "dose calculator" component (an algorithm), the document does not describe a standalone "algorithm only" performance study in the way one might for a diagnostic AI. The substantial equivalence argument relies on the overall system (pen injector + app) meeting the same performance standards as the predicate, and the clinical parameters used by the dose calculator are provided by a healthcare professional. Human factors testing focuses on the user interface and interaction, rather than an isolated algorithm's numerical output accuracy.

7. Type of Ground Truth Used

For the InPen pen injector:

• Engineering standards: Adherence to ISO 11608-1 (dose accuracy) and ISO 10993-1 (biocompatibility). These standards define the ground truth for mechanical and material performance.

For the InPen App dose calculator (algorithm):

• Clinical parameters/guidelines: The algorithm's calculations rely on patient-specific parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, fixed/variable meal sizes) programmed by a healthcare professional. The "ground truth" for the dose calculation would be its accurate application of these parameters (as per established medical guidelines for insulin dosing) to user-entered data.
• Human Factors Evaluation: For the expanded pediatric indication, human factors testing serves as the ground truth for user interface and usability safety/effectiveness in the intended population.

8. Sample Size for the Training Set

This information is not provided. The document is concerned with the current device's performance relative to a predicate, not the development or training of a de novo AI algorithm. The "dose calculator" is likely based on established physiological formulas and clinical guidelines rather than machine learning trained on a large dataset in the conventional AI sense.

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

Since a "training set" in the context of de novo machine learning is not implied or described, the method for establishing ground truth for such a set is not applicable or provided. The dose calculation logic is based on well-established medical algorithms and clinical parameters set by healthcare professionals.

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