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The Maximed Exichek TD 4224 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, and is not intended for use on neonates.

The alternative site testing in the Maximed Exichek TD 4224 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.

Maximed Exichek TD 4224 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 describes the 510(k) summary for the Maximed Exichek TD 4224 Blood Glucose Monitoring System. However, it does not contain specific details regarding acceptance criteria, reported device performance metrics (e.g., accuracy, precision), sample sizes for test or training sets, ground truth establishment methods, or information about expert involvement found in more comprehensive study reports.

The provided document only generally states that "The studies demonstrated that the performance of this system meets its intended use." and "Maximed Exichek TD 4224 blood glucose monitoring system demonstrates satisfactory performance and is suitable for its intended use."

Therefore, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numerical acceptance criteria or detailed performance metrics (e.g., bias, precision, accuracy percentages within specific ranges) are provided in the document. The document only makes a general statement about meeting intended use.

Therefore, this table cannot be generated from the given text.

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

• Test Set Sample Size: Not specified.
• Data Provenance: The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users." The country of origin for the data is implied to be Iran (where the submitter company Exir Pharmaceutical Company is located), but this is not explicitly stated as the origin of the study data. The studies are prospective as they were conducted as part of the device's validation for 510(k) submission.

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

This information is not provided in the document.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

This is a blood glucose monitoring system, not an imaging or diagnostic device typically requiring reader studies for interpretation. An MRMC study is not applicable in this context, and no such study is mentioned or implied. The device measures glucose levels directly.

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

The device is a blood glucose monitoring system with a meter and test strips. Its primary function is the "algorithm only" measurement of glucose from a blood sample. The "human-in-the-loop" aspect is the user collecting the sample and operating the device, but the measurement itself is standalone. The performance studies evaluated the system's ability to quantitatively measure glucose.

7. The type of ground truth used:

For blood glucose monitoring systems, the "ground truth" or reference method is typically obtained using a highly accurate laboratory reference instrument (e.g., YSI glucose analyzer) or a similar established method. This document does not explicitly state the specific ground truth method used, but it would be a standardized laboratory measurement.

8. The sample size for the training set:

Blood glucose meters typically do not involve "training sets" in the same way machine learning algorithms do. The device's calibration and algorithm are developed based on extensive characterization using chemical and biological samples, but a distinct "training set" as described for AI models is not applicable or mentioned here.

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

As mentioned, a "training set" in the AI sense is not applicable. The device's underlying principles and calibration would be established through a rigorous process of chemical and biological experimentation, compared against highly accurate laboratory reference methods for glucose measurement.

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