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The CLEVER CHEK TD-4232 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

CLEVER CHEK TD-4232 Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The provided text is a 510(k) summary for the CLEVER CHEK TD-4232 Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and a general statement about performance studies. However, it lacks specific details regarding acceptance criteria and the results of the studies in a structured format.

Based on the provided text, I can infer some general information but cannot fill out all requested fields.

Here's an analysis of the provided text in relation to your questions:

1. Table of acceptance criteria and the reported device performance

The document states: "The studies demonstrated that the performance of this system meets its intended use." However, it does not provide a specific table or detailed quantitative acceptance criteria and reported performance values. For blood glucose monitoring systems, acceptance criteria typically involve accuracy standards (e.g., ISO 15197) which define thresholds for agreement with a laboratory reference method.

2. Sample size used for the test set and the data provenance

The document mentions "Performance Studies... in the laboratory and in clinical settings by healthcare professionals and lay users." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information about the number or qualifications of experts used to establish ground truth. For blood glucose meters, the "ground truth" is typically established by a highly accurate laboratory reference method, not by human experts interpreting results.

4. Adjudication method for the test set

The document does not specify any adjudication method. This is not typically relevant for a blood glucose meter's accuracy studies, as the comparison is usually against a quantitative laboratory reference.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

An MRMC study is relevant for imaging devices where human readers interpret results. This device is a blood glucose monitoring system that provides a quantitative measurement. Therefore, an MRMC study was not done and is not applicable.

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

The device is a "Blood Glucose Monitoring System" consisting of a "meter and test strips." It utilizes an "electrochemical method-based meter and dry reagent biosensor." This is a standalone device that provides a direct numerical reading. Therefore, performance a standalone (algorithm only) performance study was inherently performed as the device's output is the final result, not an interpretation that requires human input for final decision-making.

7. The type of ground truth used

For blood glucose monitoring systems, the ground truth is established by a highly accurate laboratory reference method (e.g., a YSI glucose analyzer). While the document doesn't explicitly state the type of reference method, this is the standard practice for such devices.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. For traditional electrochemical blood glucose meters, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed during manufacturing and validated through performance studies.

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

As there's no mention of a "training set" in the machine learning context, the document does not describe how ground truth for a training set was established. Device calibration would involve comparisons to laboratory reference methods during development and manufacturing.

Summary of missing information:

The provided 510(k) summary is very high-level and does not include the detailed performance data, sample sizes, methodology specifics, or explicit acceptance criteria that you've requested. These details are typically found in the full 510(k) submission, not always in the summary document.

In conclusion, based solely on the provided text, I cannot complete your request comprehensively. The document confirms that performance studies were conducted and the device "demonstrates satisfactory performance and is suitable for its intended use," but it does not provide the specific data points needed to fill out your table or fully answer your questions.

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