(307 days)
The CONTOUR®NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared. The CONTOUR NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.
The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.
The CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.
The Contour NEXT EZ Blood Glucose Monitoring System consists of:
- Contour NEXT EZ Blood Glucose Meter
- Contour NEXT Blood Glucose Test Strips
- Contour NEXT Control Solutions
Acceptance Criteria and Device Performance Study for Contour NEXT EZ Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Non-clinical (ISO 15197 Section 7.3/7.4.1): A minimum of 95% of individual glucose results to fall within ±15 mg/dL of YSI analyzer results at glucose 0.990. | 100% of 717 data points were within ±10 mg/dL (0.990). |
| Detection Limit | For blood with extreme glucose levels, the meter must display "LO" or "HI" error messages. | All 72 readings at 5 mg/dL reported "LO", and all 288 readings at 900 mg/dL and higher reported "HI". Pass. |
| Analytical Specificity (Hematocrit) | Assay bias within 10 mg/dL (glucose 600mg/dL). |
- Data Provenance: Laboratory-controlled fresh venous blood.
Detection Limit Study:
- Sample Size: 8 Contour meters (3 readings per meter) with 3 test strip lots; 72 readings for low glucose (5 mg/dL) and 288 readings for high glucose (900-1800 mg/dL).
- Data Provenance: Not explicitly stated, but implies laboratory-controlled blood samples.
Analytical Specificity (Hematocrit) Study:
- Sample Size: Fresh venous blood samples (15% to 65% hematocrit), adjusted to two plasma glucose concentrations (40 mg/dL and 550 mg/dL). 12 replicates per sample collected on six Contour NEXT meters for each of three test strip lots.
- Data Provenance: Laboratory-controlled fresh venous blood samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Ground Truth Method: The ground truth for all performance studies (Accuracy, Precision, Linearity, Detection Limit, Analytical Specificity) was established by comparison to the YSI 2300 STAT PLUS glucose analyzer.
- Expert involvement: The document does not specify direct involvement of human "experts" to establish the ground truth for individual test set samples. Instead, the YSI appliance serves as the reference standard. The traceability section states the YSI analyzer is traceable to the hexokinase method, which was developed collaboratively by the FDA, CDC, NIST, and AACC. This implies expert validation of the reference method, rather than individual sample adjudication by experts.
4. Adjudication Method for the Test Set
- None specified for individual samples. The YSI 2300 STAT PLUS glucose analyzer provided a single reference value for each blood sample, acting as the definitive ground truth. There was no mention of multiple expert reads or an adjudication process for discrepancy resolution for the test samples themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described. The studies focused on the performance of the device itself against a reference standard or internal criteria. The clinical study involved users self-testing, but it was not designed as an MRMC study to compare human readers' performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone performance was done. The "Accuracy" section under "Performance Data" describes "System Accuracy Evaluation" where "Six Contour NEXT EZ meters, three lots of test strips and 100 blood samples were tested in replicates." The reported results are directly from the device's measurement compared to the YSI reference, indicating standalone algorithm performance. Similarly, all other non-clinical studies (Precision, Linearity, Detection Limit, Analytical Specificity) evaluate the inherent performance of the device's system and algorithm.
7. Type of Ground Truth Used
- YSI 2300 STAT PLUS glucose analyzer results. This is stated to be traceable to the hexokinase method, which is a recognized laboratory reference method for glucose measurement. The hexokinase method itself is "incorporated in a Bayer procedure that utilizes NIST Standard Reference Material 917, dry D-glucose." This indicates a highly accurate and standardized laboratory reference.
8. Sample Size for the Training Set
- Not explicitly stated. The document is a 510(k) summary for a blood glucose monitoring system, which typically relies on established electrochemical principles rather than machine learning algorithms that require large training sets in the same way AI-powered image analysis tools do. The "measurement algorithm" was modified, but the detail on its development and any associated "training set" (in the sense of machine learning) is not provided in this summary. Instead, the focus is on verification and validation studies using test sets.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not explicitly stated in the context of machine learning training data. As mentioned above, the device likely relies on a deterministic algorithm for glucose measurement based on electrochemical detection. Therefore, the concept of a "training set" with established ground truth as used in machine learning is not directly addressed. The device is verified and validated against established laboratory reference methods and internal criteria.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.