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The Ascensia® CONTOUR®Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

The Ascensia CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel.

The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The system contains a blood glucose meter, a bottle of strips, a bottle of normal control solution, a lancing device and lancets and instructions for use.

Here's a breakdown of the acceptance criteria and study information for the Ascensia CONTOUR® Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format for accuracy. Instead, it focuses on demonstrating "equivalent performance" to a predicate device. The performance assessment section describes the studies conducted.

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

The document mentions that the device was "studied in the laboratory and in a clinical setting by persons with diabetes." However, it does not specify the sample size for the test set or the country of origin. It indicates that the clinical setting involved "persons with diabetes," suggesting a prospective clinical study component.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth specifically for the test set. It mentions comparison to "a laboratory method," which implies a reference method, but details about the personnel executing this reference method are absent.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no information about human readers or the effect size of AI assistance. This type of study is typically relevant for interpretative devices (e.g., imaging) where expert readers provide interpretations. For a blood glucose meter, the primary comparison would be against a reference method rather than different human interpretations.

6. Standalone (Algorithm Only) Performance

The device itself is a standalone algorithm (blood glucose meter and its internal software). Its performance against the predicate and laboratory method is its standalone performance. There isn't a separate "algorithm only" study distinct from the device's overall performance.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance was established by:

• Comparison to the original Ascensia® CONTOUR® Blood Glucose Monitoring System (predicate device).
• Comparison to a "laboratory method." The specific type of laboratory method (e.g., YSI analyzer, enzymatic assay) is not detailed, but it serves as the reference standard.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. Blood glucose meters are typically calibrated during manufacturing and would have undergone extensive internal testing, but the specifics of a "training set" for algorithm development are not disclosed here.

9. How Ground Truth for the Training Set Was Established

The document does not describe how ground truth for any potential "training set" was established. Given the nature of a blood glucose meter, the "training" would likely involve robust manufacturing calibration and quality control procedures using known glucose concentrations.

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The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

The Ascensia ® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh.

The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

The Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) is used for the measurement of glucose in whole blood. The strip is one component of a system that also contains a meter, controls, lancing device, and instructions for use.

The provided document is a 510(k) summary for the Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip). It compares the modified device to a predicate device and assesses its performance. However, it does not explicitly state specific acceptance criteria (e.g., in terms of mean absolute relative difference or error grids) with defined numerical thresholds. Instead, the assessment is based on demonstrating "equivalent performance" and "substantial equivalence" to the predicate device and a laboratory method.

Here's an attempt to structure the information based on the request, inferring what can be gathered from the provided text:

Acceptance Criteria and Device Performance

Detailed Study Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states: "An evaluation of the Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) was studied in the laboratory and in a clinical setting by persons with diabetes."

   • Sample Size: The exact sample size for the test set (number of patients or measurements) is not specified in the provided text.
   • Data Provenance: The country of origin of the data is not specified. The study involved both "laboratory" and "clinical setting," and was conducted by "persons with diabetes," implying real-world usage, but the prospective/retrospective nature is not explicitly stated. It can be inferred as prospective for the clinical setting part.

2. 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):
   The ground truth was established by comparison to "a laboratory method" and the "original Ascensia® CONTOUR® Blood Glucose Monitoring System."

   • Number of Experts: The document does not specify the number of experts.
   • Qualifications of Experts: The qualifications of individuals performing the "laboratory method" are not specified.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   The document does not describe an adjudication method as it relates to expert consensus or discrepancies. The comparison was against a laboratory method and a predicate device.

4. 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:
   This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC comparative effectiveness study is not applicable in this context, and no information on human reader improvement with AI is provided.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This question is related to AI/algorithm performance. The device is a "Blood Glucose Monitoring System," which inherently involves a measurement system (modified test strip and meter). The evaluation focused on the performance of this system itself, comparing its measurements to existing methods. It's a standalone device in the sense that the measurement output is directly compared, rather than being an algorithm that assists a human.
   However, if "standalone" refers to an algorithm without human intervention in interpreting the output, then the device itself is standalone in producing a glucose reading. The performance assessment was of the "Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip)" itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was established by:

   • Comparison to results from the "original Ascensia® CONTOUR® Blood Glucose Monitoring System" (the predicate device).
   • Comparison to "a laboratory method." This "laboratory method" would typically be a highly accurate and precise reference method for blood glucose measurement (e.g., YSI analyzer, hexokinase method), often considered the gold standard for glucose concentration.

7. The sample size for the training set:
   The document describes an "evaluation" or "study" of the modified device. It does not mention a "training set" as would be relevant for machine learning algorithms. This device is a biochemical measurement system, not an AI/ML model that requires training.

8. How the ground truth for the training set was established:
   As there is no mention of a "training set" for an AI/ML model, this question is not applicable.

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