(49 days)
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
The InPen 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 Dose Calculator, based on the provided FDA 510(k) summary:
This document primarily focuses on demonstrating substantial equivalence to a predicate device (K160629) rather than presenting a novel clinical study with quantitative performance metrics against specific acceptance criteria. Therefore, the "acceptance criteria" discussed below are inferred from the demonstrated equivalence and risk management, not explicit numerical thresholds.
Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for demonstrating substantial equivalence to a previously cleared device (K160629) and not presenting new clinical performance data with explicit numerical acceptance criteria, the "acceptance criteria" are primarily established by the equivalence of the product's attributes and the successful completion of verification and validation activities. The reported "device performance" is therefore that it functions identically to the predicate device in its calculations and features, and that risks are mitigated.
| Acceptance Criteria (Inferred from Equivalence & Risk Analysis) | Reported Device Performance (as demonstrated) |
|---|---|
| Functional Equivalence to Predicate Device: | |
| - Same Indications For Use | Met: Indications for use are identical. |
| - Same Intended Use | Met: Intended use is identical. |
| - Same Technological Characteristics (Core Functionality) | Met: Core technological characteristics (e.g., insulin dose calculation algorithm, consideration of insulin on-board, manual dose entry) are identical. Minor differences are noted (Operating platform, UI Standards) but deemed not to raise new questions of safety/effectiveness. |
| - Same Principles of Operation | Met: Principles of operation (e.g., use of healthcare provider specified parameters) are identical. |
| Risk Mitigation: | |
| - All identified risks are mitigated to an acceptable level. | Met: Risk analysis completed, all design controls implemented, verified, and validated. |
| Software Verification & Validation: | |
| - Software functions according to specifications. | Met: Software V&V conducted; deemed appropriate for intended use. |
| - Software meets "Major" Level of Concern requirements. | Met: Documentation provided as recommended by FDA guidance for "major" level of concern software. |
| - Human Factors are adequate and do not introduce new risks. | Met: Human factors validation data from K160629 applies; changes to UI for critical tasks deemed to have negligible use-related risks. |
Study Information
The submission details primarily focus on demonstrating substantial equivalence to a predicate device (InPen System K160629) and robust software verification and validation (V&V), rather than a traditional clinical study with a test set of patient cases.
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Sample size used for the test set and the data provenance:
- No explicit "test set" of patient cases with clinical outcomes is mentioned in this summary for demonstrating diagnostic or predictive accuracy. The performance data section refers to "Software Verification and Validation Testing" and "Risk Analysis."
- It is likely that comprehensive software testing (unit testing, integration testing, system testing) was performed on a variety of input scenarios, but the specific "sample size" of test cases for these software tests is not quantified in this summary.
- Data provenance is not applicable in the context of a clinical test set from patient data, as no such study is described. The V&V activities would involve internally generated test data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no mention of a clinical test set requiring expert ground truth establishment for diagnostic or predictive accuracy. The "ground truth" for the software's calculations would be the mathematically correct output based on the predefined algorithm, parameters, and input data.
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Adjudication method for the test set:
- Not applicable, as no clinical test set with expert adjudication is described.
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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:
- No MRMC comparative effectiveness study is mentioned. The device is a "dose calculator" with specific instructions for healthcare professionals to program patient-specific parameters. It assists the patient in calculating doses based on these established parameters and user input, rather than augmenting human interpretation of complex medical images or data that would typically feature in an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Software Verification and Validation Testing" would essentially be a standalone evaluation of the algorithm's performance against its specifications, assuming various inputs. The summary states: "Companion Medical has demonstrated the InPen dose calculator is appropriate for its intended use through the use of hazard analysis according ISO 14971. The dose calculator uses the standard approach using healthcare provider specified insulin-to-carbohydrate ratio and insulin sensitivity factors for making calculations. In addition, the calculator includes a consideration for insulin on-board based on the published study by Mudaliar, et.al. (1999) for the duration of insulin action." This indicates the algorithm's core functionality was evaluated.
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The type of ground truth used:
- For the software's calculation accuracy: The ground truth would be the mathematically correct insulin dose or carbohydrate intake as determined by the predefined algorithms and formulas using the input parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, insulin on-board, and user-entered data). This would be established by independent calculation or a trusted reference implementation of the algorithm.
- For risk management and safety: Ground truth is implicitly established by adherence to standards like ISO 14971 and relevant FDA guidance documents.
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The sample size for the training set:
- Not applicable. This device is a rule-based dose calculator, not a machine learning model that typically requires a "training set" of data to learn from. Its "knowledge" is encoded within the algorithms and patient-specific parameters provided by a healthcare professional.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The algorithm's logic is based on established medical formulas and and a published study for insulin on-board (Mudaliar, et al., 1999).
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).