(264 days)
The Eversense AP CGM System is indicated for continually measuring glucose levels for up to 6 months in people (18 years and older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to:
· Provide real-time glucose readings.
- · Provide glucose trend information.
· Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.
The Eversense AP CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense AP CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
The system is intended for single patient use and requires a prescription.
The Eversense AP CGM System is a continuous glucose monitoring system (CGM) that provides glucose measurements every 5 minutes over a 40-400 mg/dL range. The system calculates glucose, trends and provides alerts for high and low glucose available for display on a mobile platform. It consists of a glucose sensor (the Eversense AP Sensor) that is inserted by a healthcare provider under the skin using Insertion Tools; an externally worn Eversense AP Smart Transmitter (Transmitter); and the Eversense Mobile Medical Application (MMA), which runs on a handheld device, such as a smartphone running on Android or iOS operating systems. The inserted sensor is a radiofrequency (RF)-powered device that collects readings and sends them to the Transmitter. The Transmitter calculates, stores, and transmits the glucose data via Bluetooth Low Energy (BLE) to an MMA on a handheld device (HHD).
The Eversense AP CGM System can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces: including compatible AID systems. The Eversense AP CGM System is designed to communicate with interoperable devices in several ways, such as described below:
- · Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol.
- · The app communicates through the cloud to another software device.
Acceptance Criteria and Device Performance for Eversense AP CGM System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 21 CFR 862.1357(b)(1)(v)) | Reported Device Performance (as presented in the submission) | Met? |
|---|---|---|
| **A. For iCGM measurements 85%. | **iCGM Glucose Range 70%. | iCGM Glucose Range 70-180 mg/dL: 83.1% (95% LB: 82.6) |
| Comparator Glucose Range 70-180 mg/dL: 82.3% (95% LB: 81.8) | Yes | |
| C. For iCGM measurements > 180 mg/dL: Percentage of iCGM measurements within +/-15% of corresponding blood glucose, with lower one-sided 95% confidence bound (LB) > 80%. | iCGM Glucose Range >180 mg/dL: 87.0% (95% LB: 86.5) | |
| Comparator Glucose Range >180 mg/dL: 88.8% (95% LB: 88.3) | Yes | |
| **D. For iCGM measurements 98%. | **iCGM Glucose Range 99%. | iCGM Glucose Range 70-180 mg/dL: 99.2% (95% LB: 99.07) |
| Comparator Glucose Range 70-180 mg/dL: 99.2% (95% LB: 99.1) | Yes | |
| F. For iCGM measurements > 180 mg/dL: Percentage of iCGM measurements within +/-40% of corresponding blood glucose, with lower one-sided 95% confidence bound (LB) > 99%. | iCGM Glucose Range >180 mg/dL: 99.3% (95% LB: 99.2) | |
| Comparator Glucose Range >180 mg/dL: 99.7% (95% LB: 99.6) | Yes | |
| G. Throughout the product measuring range (40-400 mg/dL): Percentage of iCGM measurements within +/-20% of corresponding blood glucose, with lower one-sided 95% confidence bound (LB) > 87%. | Overall (40-400 mg/dL): 92.1% (95% LB: 91.8) | Yes |
| H. When iCGM values 180 mg/dL. | Not explicitly stated in a percentage or metric for "no corresponding blood glucose value". However, the concurrence table shows that when iCGM is 80 mg/dL, and none were >120 mg/dL. The "LO" agreement table for iCGM readings shows that when iCGM reads "LO" (i.e., 180 mg/dL, no corresponding blood glucose value shall read 180 mg/dL, only a small percentage of Comparator values were below 160 mg/dL. The "HI" agreement table for iCGM readings shows that when iCGM reads "HI" (i.e., >400 mg/dL), 100% of the comparator values were >250 mg/dL. This implies the criteria is met. | Yes (Implied) |
| **J. No more than 1% of iCGM measurements indicate a positive glucose rate of change > 1 mg/dL/min when corresponding true negative glucose rate of change 2). This means less than 1% of iCGM measurements reflect a substantial positive change when the true change is substantially negative. | Yes | |
| K. No more than 1% of iCGM measurements indicate a negative glucose rate of change 2 mg/dL/min. | Comparator Rate Range >2 mg/dL/min: 0.8% (for iCGM Rate Range [-2,-1)). This means less than 1% of iCGM measurements reflect a substantial negative change when the true change is substantially positive. | Yes |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 111 subjects
- Data Provenance: Prospective, multi-center study conducted in the United States at 4 sites.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable, as the ground truth was established using a laboratory-based glucose measurement method, not expert consensus/interpretation of images/data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. The accuracy was determined by comparing CGM values directly to an FDA-cleared laboratory glucose analyzer. There was no mention of an adjudication process among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. The study did not involve human readers evaluating cases with and without AI assistance. It focused on the direct comparison of the device's measurements to a laboratory reference.
- Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.
6. Standalone Performance (Algorithm Only)
- Standalone Performance Done?: Yes. The entire accuracy performance evaluation, including the comparison to the FDA-cleared laboratory glucose analyzer and the various statistical analyses (percentage within limits, mean bias, MARD, alert rates), represents the standalone performance of the Eversense AP CGM System algorithm. The human element was in the form of healthcare providers inserting the sensor and managing the study, not in interpreting the CGM data for comparison against the ground truth.
7. Type of Ground Truth Used
- Type of Ground Truth: Laboratory-based blood glucose values from an FDA-cleared laboratory glucose analyzer (Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer). This is referred to as the "comparator method."
8. Sample Size for Training Set
- The document does not explicitly state the sample size for a separate "training set." The clinical study described appears to be the primary dataset for validation. Continuous Glucose Monitoring (CGM) systems typically use internal algorithms that are developed and refined using extensive datasets, but the specific details of these internal training sets are often proprietary and not fully disclosed in regulatory summaries unless it's a novel AI/ML algorithm requiring specific testing protocols for adaptive algorithms. The clinical study described here is primarily a validation study for the finalized device.
9. How Ground Truth for Training Set Was Established
- Given that a specific training set is not detailed, the method for establishing its ground truth is also not described. However, general practice for CGM systems would involve similar methods to the test set: comparison against accurate laboratory reference glucose measurements.
N/A