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510(k) Data Aggregation
(97 days)
The MiniMed 780G insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The MiniMed 780G insulin pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The MiniMed 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.
The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.
The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.
The MiniMed 780G insulin pump ("780G ACE Pump") is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used both alone and in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery.
The 780G insulin pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump that contains pump software and houses electronics, a pumping mechanism, a user interface, and a medication reservoir within the same physical device. The pump also contains a bolus calculator that calculates an insulin dose based on user-entered data. It is comprised of several discrete external and internal components including a pump case made of a polycarbonate blend, an electronic printed circuit board assembly stacks and a drive motor system.
The 780G Pump is an interoperable device that can communicate via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The 780G pump is a host device for the iAGC and integrates iAGC algorithm into the pump firmware. The pump is then able to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data via BLE interface from a compatible iCGM or a compatible interoperable Medtronic CGM and transmits these CGM data to the embedded iAGCs.
The 780G pump can operate in one of two modes: Manual Mode or Auto Mode (also referred to as "SmartGuard Mode"). The pump provides the user with keypad pump controls, as well as a data screen for configuring therapy settings and viewing continuous real-time glucose values, glucose trends, alerts, alarms, and other information. The user interface and alerts provide the user with the ability to interact with the pump delivery system and digitally connected devices.
The provided FDA 510(k) clearance letter and summary for the MiniMed 780G Insulin Pump (K253470) do not contain the detailed information required to fill out all requested sections of the acceptance criteria and study design. This document focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements, rather than providing a detailed clinical study report suitable for assessing device performance against specific, quantifiable acceptance criteria in the manner requested.
However, based on the provided text, I can extract and infer some information, and note where specific details are missing.
Here's an attempt to answer your request based on the provided text:
Acceptance Criteria and Device Performance for MiniMed 780G Insulin Pump
The provided FDA 510(k) summary extensively references compliance with regulatory standards and performance compared to predicate devices, particularly for "Delivery Volume Accuracy" and "Bolus Delivery Accuracy" which specify numerical criteria. Other performance aspects are described more qualitatively as meeting requirements or demonstrating safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (as reported or inferred) | Reported Device Performance |
|---|---|---|
| ACE Pump (QFG) - Delivery Volume Accuracy (Basal) | ±5% (Intermediate basal delivery (1 UPH) must meet ±5% of expected) (per 60601-2-24) | Per K251032 (predicate device), implied to meet the same ±5% criteria. |
| ACE Pump (QFG) - Bolus Delivery Accuracy | ±5% (for bolus volumes ≥ 0.1 unit) (per 60601-2-24) | Per K251032 (predicate device), implied to meet the same ±5% criteria. |
| ACE Pump (QFG) - Catheter Occlusion Detection | No pump malfunctions or infusion set occlusions. | "The test results confirmed that there were no pump malfunctions or infusion set occlusions" with Humalog, NovoLog, Admelog, Fiasp, and Lyumjev U-100 insulins. (Data for Humalog, NovoLog, Admelog insulins found in K251032). |
| ACE Pump (QFG) - Drug Stability and Compatibility | Pump does not adversely affect insulins; insulins do not adversely affect the pump. | "The test results demonstrated that the 780G insulin pump does not adversely affect the insulins being delivered, and that the insulin types do not adversely affect the pump." (Data for Humalog, NovoLog, Admelog insulins found in K251032). |
| ACE Pump (QFG) - Data Logging | Logging or recording timestamped critical events as required by ACE pump special controls. | "The 780G insulin pump has been tested and verified for logging or recording timestamped critical events as required by the ACE pump special controls." |
| ACE Pump (QFG) - Cybersecurity | All cybersecurity risks with potential to impact safety were mitigated. | "All cybersecurity risks with potential to impact safety were mitigated." |
| ACE Pump (QFG) - Human Factors Validation | Device is safe and effective for intended users, uses, tasks, and environments. | "Results of the human factors validation testing demonstrated that the device is safe and effective for the intended users, intended uses and expected tasks, and intended use environments." |
| ACE Pump (QFG) - Labeling | Sufficient and satisfies applicable requirements of 21 CFR 801. | "The 780G Insulin Pump's device labeling for users and healthcare practitioners is sufficient and satisfies applicable requirements of 21 CFR 801." |
| ACE Pump (QFG) - Risk Management | All risks reduced as far as possible; overall residual risk acceptable; benefits outweigh risks. | "All risks have been reduced as far as possible. The benefit risk analysis has determined that the benefits of using the device outweighs the residual risk, and the overall residual risk is acceptable." |
| ACE Pump (QFG) - Interoperability | Compliance with FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 2017)" and ACE special controls 21 CFR 880.5730(b)(3)-(5). | Documentation provided outlining strategy and approach, and demonstrating compliance. |
| General Performance (All) | All tests passed and met acceptance criteria. | "All tests passed and met the acceptance criteria. The test results demonstrate that the device met the specified requirements." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The document refers to various "testing" and "verification activities" but does not detail the sample sizes for these tests (e.g., number of pumps, number of test cycles, number of patients, etc.).
- Data Provenance: The studies appear to be pre-market, non-clinical bench testing conducted by the manufacturer, Medtronic MiniMed, Inc. There is no indication of clinical study data or geographical origin of patient data (e.g., country of origin) as this particular submission focuses on the device and not a clinical study of its use. Many tests refer back to the predicate device (K251032).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Specified. The document describes non-clinical performance and engineering validation tests (e.g., accuracy, stability, cybersecurity, human factors). These types of tests typically rely on objective measurements against engineering specifications or regulatory requirements, rather than expert-established ground truth in the context of diagnostic interpretation. Human Factors validation involved intended users but the details about "experts" to establish a ground truth in a diagnostic sense are not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / None Specified. This methodology (e.g., 2+1, 3+1 for clinical adjudication) is used for establishing ground truth in diagnostic studies, typically when evaluating algorithmic performance against human interpretation. The provided text describes engineering and regulatory compliance testing where such adjudication methods are not typically employed.
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
- No. The provided text does not describe an MRMC comparative effectiveness study. This device is an insulin pump, not a diagnostic imaging AI system assisting human readers. The human factors validation is a separate type of study focusing on device usability and safety, not diagnostic performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly for many aspects. Many of the tests described are standalone performance evaluations of the device, its firmware, and its capabilities without human intervention beyond setting up the test (e.g., Delivery Volume Accuracy, Catheter Occlusion Detection, Data Logging, Cybersecurity, Software Verification). The bolus calculator's operation within the pump would also be a standalone algorithmic function based on user input. The "Manual Mode" and "Auto Mode" imply different levels of automation, but the core technical tests are often standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The type of "ground truth" varies by the specific test and is generally based on objective engineering and regulatory standards and reference methods.
- Delivery Accuracy: Ground truth is the precisely measured or theoretical ideal insulin volume/rate against which the pump's actual delivery is compared.
- Occlusion Detection: Ground truth would be the presence or absence of an occlusion under controlled test conditions.
- Drug Stability/Compatibility: Ground truth is the chemical stability of insulin and the integrity of pump materials under test conditions.
- Data Logging: Ground truth is the expected logging behavior as per design specifications and regulatory requirements.
- Cybersecurity: Ground truth is the identified vulnerabilities and presence of effective mitigations.
- Human Factors: Ground truth is the identification of safety-critical tasks and demonstration of safe and effective completion by intended users, often against predefined success criteria.
8. The sample size for the training set
- Not Specified / Not Applicable. The document does not describe a machine learning algorithm that undergoes a "training phase" with a specific dataset in the context of the device's development or regulatory submission. While the device contains firmware and potentially algorithms (like the iAGC algorithm embedded in the pump), the text focuses on verification and validation of the device itself against engineering specifications and regulatory controls, not the training of a learning algorithm. The iAGC is described as an embedded algorithm, but its training data or methodology are not part of this 510(k) summary.
9. How the ground truth for the training set was established
- Not Applicable. As no training set is described for a machine learning algorithm, the method for establishing its ground truth is not relevant to this document.
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