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The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

The FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running on Android operating system. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.

The document details the FreeStyle Libre 3 Continuous Glucose Monitoring System and its performance testing to support substantial equivalence to its predicate device, the FreeStyle Libre 2 Flash Glucose Monitoring System.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a bridging clinical study was conducted, and the "combined System accuracy of the FreeStyle Libre 3 System and FreeStyle Libre 2 System met the iCGM special controls requirements per 21 CFR 862.1355." However, specific numerical acceptance criteria (e.g., MARD percentage, accuracy at different glucose ranges) and the exact reported performance of the FreeStyle Libre 3 System are not explicitly listed in a detailed table within the provided text segments. Instead, a general statement of meeting the iCGM special controls is given.

To fill this, we must infer that the implicit acceptance criteria are those defined by the iCGM special controls (21 CFR 862.1355) for integrated continuous glucose monitoring systems. These typically include accuracy metrics like MARD (Mean Absolute Relative Difference) against a reference method, as well as performance across different glucose ranges (hypoglycemic, euglycemic, hyperglycemic). Without the actual study report, we cannot provide specific numbers for the FreeStyle Libre 3's performance or exact acceptance criteria.

General Interpretation of iCGM Special Controls (Implicit Acceptance Criteria):
iCGM special controls generally require demonstration of:

• Accuracy: Sufficient accuracy across the glucose range (e.g., MARD values below a certain threshold when compared to a laboratory reference).
• Safety: Acceptable safety profile with minimal adverse events.
• Performance in various conditions: Performance evaluated across different patient populations, wear sites, and duration of use.
• Alarm performance: Accuracy and reliability of hypoglycemia and hyperglycemia alarms.
• Interoperability: Functionality with digitally connected devices.

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

The document states: "ADC conducted a bridging clinical study to demonstrate comparability of the performance of the FreeStyle Libre 3 System to the predicate FreeStyle Libre 2 System, cleared under K210943."

• Sample Size for Test Set: Not explicitly stated in the provided text.
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). It is implied to be prospective as it's a clinical study for FDA clearance.

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

This information is not provided in the text. For CGM devices, the "ground truth" (reference glucose values) is typically established using a highly accurate laboratory reference method (e.g., YSI glucose analyzer) on blood samples, not expert consensus interpreting images or clinical cases. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation is not directly applicable here. The ground truth would be the laboratory-measured glucose values.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is primarily relevant for studies where multiple human readers interpret data (e.g., radiology images) and a consensus or tie-breaking mechanism is needed for the ground truth. For a CGM device, the ground truth is established by a quantitative, objective measurement (laboratory blood glucose). Therefore, an adjudication method in this context is not applicable/not mentioned as it's not a reader study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The FreeStyle Libre 3 is a standalone device that measures glucose; it does not involve human readers interpreting its output in a diagnostic context that would warrant an MRMC study. The "comparative effectiveness" mentioned refers to its performance against a predicate device and standard laboratory methods, not a comparison of human reader performance with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone study was done. The entire premise of the submission is to demonstrate the performance of the FreeStyle Libre 3 System as a standalone integrated continuous glucose monitoring device. The bridging clinical study, designed to show "comparability of the performance of the FreeStyle Libre 3 System to the predicate FreeStyle Libre 2 System," inherently evaluates the algorithm's performance without direct human intervention in the glucose measurement and calculation process. The FreeStyle Libre 3 delivers "real-time continuous glucose measurements every minute" and its "System accuracy" was evaluated.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a CGM device is typically a highly accurate laboratory reference method (e.g., YSI glucose analyzer) performed on venous blood samples taken concurrently with the CGM readings. While not explicitly stated, this is the standard for CGM accuracy studies.

8. The Sample Size for the Training Set

The document mentions that the "Sensor Glucose Algorithm established for the predicate device" is the same for the FreeStyle Libre 3. It also states that the FreeStyle Libre 3 contains a "software algorithm for conversion of the raw glucose measurements from the Sensor to calculate glucose results." This implies the algorithm was developed and trained prior to this submission, likely using data from previous FreeStyle Libre sensor generations.

The sample size for the training set is not provided in this document.

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

Given that the "Sensor Glucose Algorithm" is the same as the predicate device, it can be inferred that the ground truth for training this algorithm was established similarly to the predicate device's clearance. This would typically involve pairing sensor readings with laboratory reference blood glucose measurements (e.g., YSI) taken from human subjects during previous clinical studies. The specific details of how this ground truth was established for the training set are not provided in the given text.

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