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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.

The Bigfoot Unity Diabetes Management System ('Bigfoot Unity System') integrates 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.'s 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 Bigfoot Unity Diabetes Management System is an integrated continuous glucose monitor (iCGM) designed to assist individuals with diabetes in managing their insulin doses. It incorporates the Abbott FreeStyle Libre 2 Flash Glucose Monitoring system and provides insulin dose recommendations based on glucose data.

Here's an analysis of the acceptance criteria and supporting studies as described in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance metrics for the Bigfoot Unity System as a complete system beyond the predicate device's performance. Instead, it states that various tests met their respective acceptance criteria, implying successful performance without detailing those criteria quantitatively for this device.

However, it does reference the analytical and clinical performance of the Abbott FreeStyle Libre 2 Flash Glucose Monitor (K193371), which forms a core component of the Bigfoot Unity System. The acceptance criteria for the integrated system are, in part, based on the successful integration and continued performance of this pre-cleared component and the proper functionality of the new elements (pen caps, mobile app, dose recommendations).

Summary of General Performance Claims:

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

The document does not specify the sample size used for the test set for the Bigfoot Unity System's custom components (e.g., pen caps, mobile app, dose recommendations). It mentions "bench test results," "human factors and usability testing," "software verification and validation testing," and "wireless coexistence and EMC testing," but without numerical details on participants or data points.

For the Abbott FreeStyle Libre 2 Flash Glucose Monitor, its analytical and clinical performance was assessed under K193371. The provenance of this data would be from the studies submitted for that specific 510(k) clearance, which is not detailed in this document. Generally, such studies involve prospective clinical trials to evaluate accuracy against a reference method (e.g., YSI glucose analyzer) in a clinical or home-use setting, typically involving participants from various countries (though often with a significant US cohort).

The data concerning the Bigfoot Unity System's specific new features (dose recommendations, pen caps, mobile app) appears to be from retrospective testing (bench, software V&V, environmental) or prospective limited user testing (human factors) but no details of the number of participants or data origin are provided.

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

This information is not provided for the Bigfoot Unity System's specific components. For the Abbott FreeStyle Libre 2 (the iCGM component), the ground truth for its analytical accuracy would have been established using laboratory reference methods (e.g., YSI glucose analyzers) rather than human experts, with the data then statistically compared.

For the human factors testing, "experts" in usability engineering often oversee such studies, but the document does not specify their number or qualifications. The "ground truth" in human factors is often defined by the successful completion of critical tasks without errors, which is assessed against predefined task flows and safety parameters.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for any test sets related to the Bigfoot Unity System beyond the inherent statistical comparisons and validation processes for technical performance. Since no expert concensus or clinical outcome adjudication is explicitly mentioned for the new components, it appears that direct performance against established technical specifications or usability metrics was used.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Bigfoot Unity System is an iCGM with dose recommendations, not an imaging device, so an MRMC study would generally not be applicable in this context. There is no information provided regarding the effect size of human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly describe a standalone algorithm-only performance study for the Bigfoot Unity System's dose recommendation functionality. However, the software verification and validation activities would have tested the internal logic and calculations of the algorithm in a standalone manner (i.e., verifying that given specific glucose data and patient settings, the algorithm outputs the correct dose recommendation according to its specifications). The output of the dose recommendation, while displayed to the user for manual action, is a direct algorithmic output. The performance of the FreeStyle Libre 2 sensor itself is a standalone performance of the glucose monitoring component.

7. Type of Ground Truth Used

For the glucose monitoring component (FreeStyle Libre 2), the ground truth is typically laboratory reference methods (e.g., YSI glucose analyzers for blood glucose levels).

For the Bigfoot Unity System's new components:

• Software Verification and Validation: Ground truth is established by pre-defined functional specifications and requirements. The software is verified to produce expected outputs given specific inputs.
• Human Factors: Ground truth is established by safety and usability metrics, where critical tasks are expected to be completed without error, and the interface is easily understandable.
• Bench, Environmental, EMC, Biocompatibility: Ground truth is established by international standards and regulatory requirements (e.g., ISO, IEC).

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The Bigfoot Unity System's dose recommendation functionality is based on a pre-programmed algorithm reflecting healthcare provider prescribed insulin dosing regimens, not a machine learning model that requires a "training set" in the conventional sense of supervised learning. The FreeStyle Libre 2 sensor would have undergone calibration and potentially model training (if AI is used for signal processing/accuracy improvements) but that detail is not provided here.

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

As noted above, a "training set" for a machine learning model is not explicitly indicated for the Bigfoot Unity System's new components. The system primarily implements established clinical protocols for insulin dosing. Therefore, the "ground truth" for the dose recommendation logic would be based on clinical guidelines and established medical practice for insulin dosing, as prescribed by a healthcare provider. The software validates that it correctly implements these rules.

For the underlying FreeStyle Libre 2 iCGM, if it uses machine learning, the ground truth for any potential sensor calibration/algorithm training would have been established through comparison to laboratory reference glucose measurements (e.g., from YSI devices) from clinical studies.

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