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The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

The FreeStyle Libre 2 Flash Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL2 System' and FreeStyle Libre 3 Continuous Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL3 System' are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The Systems also provide configurable alarms designed to warn the user of Low Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by the Systems require a prescription and are intended for home use.

The FreeStyle Libre 2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device.

Both the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.

The Abbott FreeStyle Libre 2 Flash Glucose Monitoring System and FreeStyle Libre 3 Continuous Glucose Monitoring System sought clearance for modified sensor tails to reduce vitamin C interference, extend sensor wear to 15 days, and enable compatibility with automated insulin dosing (AID) systems.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly list a table of "acceptance criteria" with specific numeric targets for device performance. Instead, it states that the devices meet the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. This regulation broadly outlines requirements for accuracy, reliability, and safety of integrated Continuous Glucose Monitoring systems.

However, based on the provided text, we can infer some key performance objectives and the reported outcome:

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

• Sample Size: The clinical study evaluated performance in adult (18 years and older) and pediatric (2 to 17 years) participants with diabetes. Specific numbers of participants within these age groups are not provided in this summary.
• Data Provenance: The document does not specify the country of origin. It indicates the studies were clinical studies, implying a prospective nature.

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

The document mentions that the clinical study evaluated performance with respect to reference venous plasma sample YSI measurements.

• Ground Truth Providers: YSI measurements are obtained from laboratory instruments, which are considered the gold standard for glucose measurement. The "experts" involved would be trained lab technicians and medical professionals responsible for collecting and processing blood samples and operating the YSI instrumentation.
• Qualifications: Not explicitly stated, but they would be certified laboratory personnel and healthcare providers responsible for patient care and sample collection within a clinical study setting.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established by YSI laboratory measurements, not subjective expert review or adjudication.

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

A Human-in-the-loop or MRMC study is not applicable for this device type (Continuous Glucose Monitoring System). The device provides continuous glucose values, and its performance is assessed against a laboratory reference, not human interpretation of images or other data that would involve multiple readers.

6. Standalone Performance:

Yes, the studies described are primarily focused on the standalone performance of the algorithm (as embedded in the device) in measuring glucose levels against a reference method (YSI venous plasma samples). The "clinical study" directly assesses how well the device's sensor and algorithm perform without direct human intervention in the glucose reading process itself, other than the placement and use of the device by participants.

7. Type of Ground Truth Used:

The ground truth used was venous plasma sample YSI measurements. This is a highly accurate and accepted laboratory reference method for glucose concentration.

8. Sample Size for the Training Set:

The document does not specify the sample size for the training set used for the device's glucose algorithm. It mentions that the "ADC Glucose Algorithm established for the predicate device" is used, implying that the core algorithm was developed and trained previously, and this submission focuses on modifications and re-validation.

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

The document does not specify how the ground truth for the training set of the ADC Glucose Algorithm was established. However, given that the clinical performance evaluation uses venous plasma YSI measurements as ground truth, it is highly probable that similar high-accuracy reference methods would have been employed during the development and training of the original algorithm.

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