(48 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device and a laboratory method regarding blood glucose results. | "The studies showed equivalent performance with the original Ascensia® CONTOUR® Blood Glucose Monitoring System." |
| "The results of the laboratory and clinical evaluations... demonstrated that the device produces blood glucose results that are substantially equivalent to results obtained on the predicate device." |
Detailed Study Information:
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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.
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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.
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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. -
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. -
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. -
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.
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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. -
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.
§ 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.