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The CONTOUR®NEXT EZ blood glucose nonitoring system is an over the counter (OTC) device utilized for self-esting by persons with diabetes at home for the quantiative measurement of glucose in whole 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 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 EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System.

The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

Here's a breakdown of the acceptance criteria and study information for the Contour Next EZ Blood Glucose Meter (K130265):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Contour Next EZ Blood Glucose Monitoring System are based on ISO 15197:2003 standards for accuracy, repeatability, linearity, and intermediate precision. The provided document details the performance of the Contour Plus System as a proxy for the Contour Next EZ system, along with specific additional testing for the modified Contour Next EZ meter.

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

• Much of the analytical testing (Accuracy, Repeatability, Linearity, Intermediate Precision, EMC, Electrical Safety) was performed using the Contour Plus Blood Glucose Monitoring System and test strips, which is stated to be representative.
• Analytical Accuracy:
  • Glucose < 75 mg/dL: Three lots of test strips, with 26 measurements per lot. Total: 78 unique measurements.
  • Glucose ≥ 75 mg/dL: Three lots of test strips, with 174 measurements per lot. Total: 522 unique measurements.
• Repeatability: Not explicitly stated, but data is given for 5 glucose levels across 3 lots of test strips.
• Linearity: Blood glucose samples ranged from 0.1 mg/dL to 692 mg/dL. No specific number of samples is given, but it implies a range of concentrations were tested.
• Intermediate Precision: 300 control tests (using three lots of test strips and three levels of control solution).
• Clinical Trial (Accuracy): 220 persons with diabetes were enrolled.
  • Glucose < 75 mg/dL: 7 instances (across the 220 subjects).
  • Glucose ≥ 75 mg/dL: 209 instances (across the 220 subjects).
• Hematocrit and Temperature Combination Study: Not explicitly quantified, but performed with "Three glucose concentrations and four hematocrit levels... at temperatures of 5, 10, 22, 35, 40 and 45℃."
• Hematocrit Dependency Study: Not explicitly quantified, but performed with "Four glucose concentrations and five hematocrit levels."
• Temperature Dependency Study: Not explicitly quantified, but performed with "Three glucose concentrations were tested at temperatures of 5, 10, 15 and 22°C."
• Temperature and Humidity Combination Study: Not explicitly quantified, but tested across 5 different environmental conditions.
• Blood Sample Re-application (Lab Personnel): Not explicitly quantified, but involved "inoculated with blood to simulate severely under-filled and moderately under-filled conditions."
• Blood Sample Re-application (Lay Users):
  • Feasibility Study: Not explicitly quantified, but lay users were "trained to underfill the test strips."
  • R&D Lay User Studies: 58 instances of under-filled test strips from multiple studies.
• Error Detection of Moisture Damaged Test Strips: Not explicitly quantified, but test strips "stressed by leaving the bottles open for 23 days inside a 30°C80% RH environmental chamber."

Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Bayer Healthcare LLC" submitter, it is likely that parts of the studies, especially regulatory submissions, involve US-based data or adherence to international standards globally. The studies appear to be prospective in nature, as they involve active testing and clinical trials.

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

The ground truth for all glucose measurements was established using a YSI reference method. This is a laboratory-based, highly accurate method for measuring glucose, often considered the gold standard in such studies. The number and qualifications of experts performing the YSI reference measurements are not specified in the document, but it's implied to be performed by qualified laboratory personnel.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method for the test set. Given that the ground truth is established by a YSI reference method, which is an objective measurement, an adjudication process involving human reviewers for interpretation of results is generally not applicable in this context. The comparison is directly between the device reading and the YSI reference.

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

No MRMC comparative effectiveness study was done in the conventional sense (i.e., comparing human readers' performance with and without AI assistance). This device is a blood glucose meter, and the primary assessment is its analytical accuracy against a reference standard, not its impact on human interpretation of images or other subjective data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance was done. All the analytical accuracy, repeatability, linearity, intermediate precision, and various environmental/interference studies (hematocrit, temperature, humidity) reflect the standalone performance of the device (system/algorithm). The clinical trial also evaluates the system's accuracy "in the hands of intended users," which still primarily assesses the device's output against the ground truth, rather than human diagnostic performance. The "Blood Sample Re-application (Lab)" and "Error Detection of Moisture Damaged Test Strips" studies directly test the algorithmic improvements implemented in the modified device.

7. The Type of Ground Truth Used

The primary ground truth used for glucose measurements throughout the studies is the YSI reference method. This is an objective, laboratory-based measurement of glucose concentration, considered a highly accurate standard.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for a training set. This is typical for a 510(k) submission for a blood glucose meter where the device's underlying chemistry and algorithms are often developed and validated over time, with the submission focusing on performance testing for the final product and its modifications, rather than detailing the initial machine learning model training (if any complex machine learning was even involved, which is less common for these types of electrochemical devices). The modifications described (glucose calculation algorithm, improved blood detection, error detection for damaged strips) would likely have been developed and refined using internal data before the formal validation studies presented here.

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

As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided in the document.

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