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510(k) Data Aggregation
(126 days)
The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 1 year in people (18 years or 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 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 365 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense 365 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 365 Continuous Glucose Monitoring (CGM) System provides continuous glucose measurements 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 365 Sensor) that is inserted under the skin using Insertion Tools; an externally worn Eversense 365 Smart Transmitter); and the Eversense 365 App, which runs on a compatible handheld device (HHD), such as a smartphone. 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 the Eversense 365 App on an HHD.
The CGM System consists of three principal components.
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- Sensor: The Sensor, inserted subcutaneously, receives RF-power from the Transmitter to measure interstitial fluid glucose every 5 minutes. The Sensor sends fluorescence readings or data to the Transmitter for calculation and storage of glucose values. The Sensor has a silicone collar component that contains an anti-inflammatory steroid drug (dexamethasone acetate) that elutes locally to reduce tissue inflammation around the Sensor. The Sensor operating life is up to one year or until the device's end-of-life is reached, whichever occurs first. The Sensor is provided sterile, for single use in a Sensor Holder. The Sensor is inserted using the provided Insertion Tools.
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- Transmitter: The Transmitter, worn externally over the inserted Sensor, is a device with rechargeable battery that powers the Sensor, calculates the glucose values from the Sensor-measured fluorescence readings, and using secure BLE wirelessly sends the glucose information to the Eversense 365 App for display on the HHD. An adhesive patch holds the Transmitter in place. The Transmitter is charged using the provided power cord and charge adapter. The Transmitter also provides vibration signals for alerts and notifications, such as low glucose levels, irrespective of whether the Eversense 365 App is in the vicinity or not.
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- App: The Eversense 365 App is a software application that runs on an HHD (e.g., compatible mobile device) for display of glucose information provided by the Transmitter. The Eversense 365 App receives and displays the calculated glucose information from the Transmitter, including glucose trend information and glucose alerts. The Eversense 365 App also allows the user to calibrate the CGM System. It also communicates with the Senseonics server for a one-time download of calibration parameters specific for each Sensor following the insertion as part of the linking process. The Eversense 365 App also provides the user an option to upload the data to Senseonics Data Management System (DMS) for historic viewing and storing of glucose data.
The provided text is a summary of a 510(k) premarket notification for the Eversense 365 Continuous Glucose Monitoring (CGM) System. It details the device, its intended use, comparison to a predicate device, and performance data from a clinical study.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the "iCGM Special Controls" listed in Tables 4, 5, and 6. The reported device performance is the "Eversense 365 CGM System Performance" and "Eversense 365 Results" columns.
| iCGM Special Control (Acceptance Criteria) | iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Acceptance Criteria (95% Lower Bound) | Reported Device Performance (Point Estimate) | Reported Device Performance (95% Lower Bound) |
|---|---|---|---|---|---|
| System Agreement to Reference within ± 15 mg/dL/15% | |||||
| (1)(v)(A) | 85% | 87.2% | 86.3% | ||
| (1)(v)(B) | 70-180 | 23049 | >70% | 81.9% | 81.5% |
| (1)(v)(C) | >180 | 14408 | >80% | 89.3% | 88.9% |
| System Agreement to Reference within ± 40 mg/dL/40% | |||||
| (1)(v)(D) | 98% | 99.0% | 98.7% | ||
| (1)(v)(E) | 70-180 | 23049 | >99% | 99.4% | 99.3% |
| (1)(v)(F) | >180 | 14408 | >99% | 99.8% | 99.7% |
| Overall iCGM Glucose Range: (1)(v)(G) | Overall (40-400) | 40497 | >87% | 92.0% | 91.8% |
| iCGM Special Controls (1)(v)(H)-(K) Through 365 Days | |||||
| (1)(v)(H) | 180 mg/dL | 0 values > 180 mg/dL | N/A | ||
| (1)(v)(I) | >180 | 40497 | No blood glucose value 1mg/dL/min when the corresponding true negative rate of change is 2mg/dL/min | 0.4% (3/806) | N/A |
All reported Eversense 365 CGM System Performance values meet or exceed the specified Special Control (acceptance criteria) thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 110 adult subjects (ages 18 years and older). The document also refers to
Matched Pairs (N)for accuracy metrics, which sum up to 40497 for the overall accuracy, representing individual CGM readings matched with reference glucose values. - Data Provenance: The ENHANCE Study was a prospective, multi-center study conducted at 4 sites in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The text does not specify the number of experts or their qualifications used to establish the ground truth. It states that "The accuracy of the Eversense 365 CGM System was evaluated during clinic visits comparing CGM glucose values and plasma glucose values measured using a bedside glucose analyzer."
4. Adjudication Method for the Test Set
The text does not specify an adjudication method. The ground truth was established by a laboratory-based glucose analyzer.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a Continuous Glucose Monitoring (CGM) system, which directly measures glucose and provides readings, trend information, and alerts. It does not involve human readers interpreting images or data with or without AI assistance in the context of diagnostic imaging. The "AI" component would be the algorithm within the CGM system itself (e.g., for calculating glucose values from sensor readings, trend analysis, and alerts), not an interpretative aid for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance data presented (Tables 4-6) reflect the standalone performance of the Eversense 365 CGM System. The accuracy metrics compare the device's generated glucose values directly against a laboratory reference method (YSI 2300 Stat Plus Glucose & Lactate Analyzer). The device is designed to "replace fingerstick blood glucose measurements for diabetes treatment decisions" and "autonomously communicate with digitally connected devices" – implying its ability to function without human interpretation of its raw sensor data.
7. The Type of Ground Truth Used
The ground truth used was plasma glucose values measured using a bedside glucose analyzer (specifically, a Yellow Springs Instruments (YSI) 2300 Stat Plus Glucose & Lactate Analyzer, which is an FDA-accepted laboratory-based glucose measurement method). This is a type of reference standard or outcome data (measured physiological parameter).
8. The Sample Size for the Training Set
The text does not provide information regarding the sample size of the training set for the device's algorithms. The clinical study (ENHANCE Study) is described as an evaluation of the device's accuracy and safety, implying it served as a test or validation set rather than a training set.
9. How the Ground Truth for the Training Set Was Established
Since the text does not mention the training set size, it also does not specify how ground truth for any training set was established.
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