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The Contour Next USB blood glucose monitoring system is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared.

The system consists of a Contour Next USB blood glucose meter, Contour Next test strips and Contour Next control solutions.

The Contour Next USB blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The Contour Next USB blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The Contour Next Test Strips are for use with the Contour Next USB blood glucose monitoring system for the quantitative measurement of glucose in whole blood.

The Contour Next USB 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 USB 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.

This document is a 510(k) premarket notification for the Contour Next USB Blood Glucose Monitoring System, which primarily describes modifications to an existing predicate device (K121087) rather than providing a detailed study of the modified device's performance against specific acceptance criteria. The modifications focus on improved error detection capabilities.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth for a full performance study is not explicitly detailed in the provided text. The submission focuses on demonstrating substantial equivalence to the predicate device due to specific enhancements.

Here's an attempt to extract the available information based on your request, with noted limitations where data is not provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format for blood glucose measurement accuracy for the modified device. Instead, it describes functional improvements related to error detection. The "reported device performance" focuses on the functionality of these new error checks and equivalency to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified. The document mentions "bench testing" and an "internal user study" but does not give sample sizes for either.
• Data Provenance: Not specified, but likely proprietary internal data from Bayer Healthcare. It doesn't specify country of origin or whether it's retrospective or prospective. Given the context of 510(k) submissions, such studies are typically prospective tests conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable or not specified. This type of submission for a blood glucose meter does not typically involve expert consensus to establish ground truth in the same way an imaging or diagnostic AI device would. The "ground truth" for a blood glucose meter is usually established by a laboratory reference method. The document mentions "internal user study," suggesting lay users may have been involved in some testing, but no details on expert involvement for ground truth are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable or not specified. Adjudication methods like 2+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts review and reconcile differences. For a quantitative device like a blood glucose meter, ground truth is established by a reference method, not by expert adjudication.

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

Not applicable. MRMC studies are relevant for devices that assist human readers (e.g., AI for medical imaging). This is a standalone diagnostic device. The study mentions an "internal user study" but not in the context of an MRMC design or comparing human performance with/without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence. The bench testing and software verification of the error detection mechanisms would fall under "standalone" algorithm testing to ensure the meter correctly identifies errors and does not misclassify good results. The equivalency testing would also implicitly assess the algorithm's accuracy compared to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood glucose meters, the ground truth for accuracy studies is typically established by a laboratory reference method (e.g., YSI glucose analyzer) for whole blood glucose concentration. While not explicitly stated for this specific submission, this is the standard for blood glucose meter validation. The text focuses on the functional correctness of its new error checks rather than primary accuracy data against a reference method, as it's demonstrating equivalence to an already cleared device.

8. The sample size for the training set

Not applicable. As a medical device (blood glucose meter) and not an AI/ML algorithm that requires a "training set" in the conventional sense, this information is not relevant or provided. The "training" for such a device is its design and manufacturing process, and its performance is validated through testing.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of AI/ML for this device.

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The CONTOUR® NEXT USB Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The CONTOUR® NEXT USB Blood Glucose Monitoring System may be used as an aid to monitor the effectiveness of a diabetes control program and is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Contour® NEXT Test Strips are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood. The Contour® NEXT Controls are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System to check that the meter and test strips are working properly.

Glucofacts® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by health care professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Baver's Contour and Breeze families of meters.

The Contour NEXT USB Blood Glucose Monitoring System consists of a small handheld blood glucose meter that is substantially equivalent in look and feel to the predicate system. Contour Next Wireless Blood Glucose Meter, (K110894). The system also consists of dry reagent test strips used for the measurement of glucose in capillary whole blood and includes liquid controls to check the performance of the system.

The chemical principle of the system 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.

The Bayer Contour NEXT USB Blood Glucose Monitoring System was tested and found to meet the system accuracy requirements of ISO 15197:2003 through analytical performance testing and a user performance evaluation.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ISO 15197:2003 for system accuracy.

**System Accuracy - Glucose Concentrations

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