(215 days)
The Bigfoot Unity® Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older.
Bigfoot Unity® provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription.
Bigfoot Unity® is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.
Bigfoot Unity Diabetes Management System ("Bigfoot Unity System") integrates The continuous glucose monitoring with insulin dose recommendations to support people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. The system consists of the Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring system ("FreeStyle Libre 2") integrated continuous glucose monitor (iCGM) sensor, two reusable insulin pen caps (one each for rapid-acting and long-acting insulin pens) and a mobile application. The components communicate via near field communication (NFC) and Bluetooth.
The device generates glucose data using the FreeStyle Libre 2 sensor and displays the data (value and trend) on the rapid-acting insulin pen cap. The rapid-acting pen cap also displays correction and meal insulin doses based upon settings prescribed by the user's healthcare provider and the available glucose data. The long-acting pen cap displays the long-acting insulin dose prescribed by the user's healthcare provider. From the dose recommendations on the pen caps as well as other contextually relevant information such as glucose trend arrows and current exercise status, users determine the doses to take. Users manually select an insulin dose and administer it using the pens according to the insulin manufacturers' instructions. In addition to dose information, both pen caps track the time of insulin doses.
The mobile app provides fixed and configurable system alerts based upon data generated by the FreeStyle Libre 2 sensor. It also enables entry of the healthcare provider prescribed insulin dosing regimen as well as provides system alerts and historical information. In addition, the mobile app manages the secure wireless communication between the system components and enables the transfer of the system data to the cloud.
The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study results for the Bigfoot Unity® Diabetes Management System in the format requested. The document is a 510(k) summary, which typically provides an overview rather than granular study details.
However, based on the information provided, here's what can be extracted and inferred about the studies conducted:
1. A table of acceptance criteria and the reported device performance:
The document states: "In all instances, the Bigfoot Unity System functioned as intended and the results of the testing met the acceptance criteria." and "Results of the software executed protocols for the Unity System met the acceptance criteria and therefore support that the Bigfoot Unity software is acceptable for its intended use."
The specific numerical acceptance criteria and corresponding reported device performance metrics (e.g., accuracy percentages, error rates) are not detailed in this summary. The summary refers to the compliance with various standards and successful completion of tests.
2. Sample sized used for the test set and the data provenance:
- Software Verification and Validation: Not specified.
- Human Factors: Not specified.
- Electromagnetic Compatibility and Electrical Safety: Not specified.
- Cybersecurity: Not specified.
- Analytical and Clinical Performance: "The following performance characteristics were established for the predicate Bigfoot Unity System in K202145 and are not impacted by the modifications leading to the subject device." This implies that the clinical performance data comes from the predicate device (K202145), but the sample size and provenance of that predicate study are not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Ground truth establishment, if applicable to the studies mentioned (e.g., analytical and clinical performance from the predicate), is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
The document describes the device as providing "insulin dose information using the available glucose data to assist persons with diabetes mellitus" and "dose recommendations based on glucose information where the user manually controls actions for therapy decisions." While it assists users, there is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers (users) with and without AI assistance for this device. The focus is on the system providing recommendations based on glucose data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The software verification and validation section indicates that standalone algorithm performance was evaluated: "Verification activities included unit, component, system integration, and system level testing which verified functionality of the device against established software requirements." This would implicitly involve algorithm-only testing to ensure it meets specifications before assessing human interaction.
7. The type of ground truth used:
- For software verification and validation: "established software requirements" serve as the ground truth.
- For human factors: "safe and effective use of the device by the intended user groups" and compliance with "FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices (2016) and ANSI/AAMI/IEC 62366" serve as ground truth or benchmarks.
- For electromagnetic compatibility and electrical safety: Compliance with "IEC 60601-1:2005", "IEC/EN 60601-1-2:2014", "IEC CISPR 11", "IEC 60601-1-11:2015", and FDA guidance for "Radio Frequency Wireless Technology in Medical Devices" are the ground truths.
- For cybersecurity: "analysis of confidentiality, integrity, and availability for data, information and software" with "appropriate risk mitigation controls" being the ground truth.
- For analytical and clinical performance: This refers to the predicate device (K202145). The specific type of ground truth (e.g., lab reference values, clinical outcomes) for the predicate's analytical and clinical performance is not described in this document.
8. The sample size for the training set:
This information is not provided in the document. The document describes verification and validation rather than the development or training of AI models.
9. How the ground truth for the training set was established:
This information is not provided in the document, as details on a training set or its associated ground truth establishment are absent.
§ 862.1355 Integrated continuous glucose monitoring system.
(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.