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The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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 above systems can be used only during steady-state blood glucose conditions.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for the TaiDoc Technology Corporation Blood Glucose Monitoring Systems (K090185) does not contain the detailed information necessary to answer your request about acceptance criteria and the specifics of a study proving device performance.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It lists the trade names and regulation numbers, and outlines the general controls and requirements for the device. It also includes an "Indications for Use" statement, defining how the device is intended to be used.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Details about experts used for ground truth (number, qualifications, adjudication).
4. Information on MRMC comparative effectiveness studies or standalone algorithm performance.
5. The type of ground truth used (e.g., pathology, outcomes data).
6. Sample size for the training set or how its ground truth was established.

To obtain this information, you would typically need to refer to the full 510(k) submission, which is often much more detailed and includes the actual performance data and study methodologies. The document provided is only the FDA's clearance letter.

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The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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 above systems can be used only during steady-state blood glucose conditions.

Not Found

This looks like a 510(k) summary for a blood glucose monitoring system. To answer your questions, I need to find the specific study details that demonstrate the device meets its acceptance criteria. However, the provided text does not contain the detailed study information such as acceptance criteria tables, sample sizes, ground truth establishment, or specific study designs (MRMC, standalone).

The document is primarily a notification letter from the FDA confirming substantial equivalence to predicate devices and an "Indications for Use" statement. It mentions that the FDA "reviewed your Section 510(k) premarket notification" but does not elaborate on the contents of that notification beyond the "Indications for Use."

Therefore, based solely on the provided text, I can answer some parts with "Not provided" or explain why the information isn't present:

Here's an analysis of what information is available and what is not:

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

• Not Provided. This document does not include any performance data or a table of acceptance criteria for accuracy (e.g., ISO 15197 standards for blood glucose meters).

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

• Not Provided. The document does not mention any sample sizes for test sets, data origin, or whether studies were retrospective or prospective.

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/Not Provided. For blood glucose meters, the "ground truth" is typically established by a laboratory reference method (e.g., YSI analyzer) rather than expert consensus on images. The document does not specify how ground truth was established, nor does it mention any experts in this context.

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

• Not Applicable/Not Provided. Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies involving human readers. This is a blood glucose monitoring system, and its performance is assessed against a referencemethod, not by expert adjudication of interpretations.

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 specific to diagnostic imaging and AI (Artificial Intelligence) assistance for human readers. This device is a blood glucose monitor, not an AI-powered diagnostic imaging tool, and therefore MRMC studies are not relevant in this context.

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

• Yes, implicitly. Blood glucose meters are inherently "standalone" devices (algorithm only) in the sense that they provide a numerical reading directly without human interpretation in the loop. However, the document does not contain explicit details of such standalone testing. The performance of such a device is typically evaluated against a reference laboratory method for accuracy and precision.

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

• Likely a laboratory reference method, but not explicitly stated. For blood glucose meters, the ground truth is almost universally established using a highly accurate laboratory reference instrument (e.g., YSI glucose analyzer) to measure glucose concentration in blood samples. The document does not explicitly state this, but it is the standard for these devices.

8. The sample size for the training set

• Not Applicable/Not Provided. Blood glucose meters typically do not use "training sets" in the same way machine learning algorithms do. Their calibration and performance are based on chemical and electrochemical principles, often with factory calibration and stability testing, rather than a data-driven training process.

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

• Not Applicable/Not Provided. See the answer for point 8.

Summary of Device Performance (Based on "Indications for Use" and general knowledge of 510(k) for BGM systems):

While specific performance data is not provided, the FDA's clearance (K073494) indicates that the ACHTUNG TD-4207, Clever Check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring Systems demonstrated "substantial equivalence" to legally marketed predicate devices. This implies that the sponsor provided data (which is not in this document) to the FDA showing that these devices meet accepted performance standards for blood glucose meters, likely including accuracy and precision metrics comparable to the predicate devices and/or ISO 15197 standards.

The "Indications for Use" specifies:

• Intended Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh).
• User: Healthcare professionals and people with diabetes mellitus at home.
• Purpose: Aid in monitoring the effectiveness of diabetes control program.
• Exclusions: Not for diagnosis or screening of diabetes mellitus, not for use on neonates.
• Limitation for ALT: Alternative site testing can be used only during steady-state blood glucose conditions.

To get the detailed information you are looking for (acceptance criteria, specific performance data, sample sizes, etc.), you would typically need to review the full 510(k) submission available through FDA's public access, which often includes a more detailed summary of safety and effectiveness data. This provided document is primarily the FDA's response letter and the indications for use.

Ask a specific question about this device