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The Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure 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 systems can be used only during steady-state blood glucose conditions.

The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home.

For Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217 system, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25″ ~ 7.75″ .

For Clever Chek TD-3250 system, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".

The Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System consists of a monitor with wrist/arm cuff 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 system is able to provide blood pressure measurement which adopts the "oscillometric method" as the measuring principle. It provides the systolic pressure, diastolic blood pressure and pulse rate on an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist (Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217) or in the arm (Clever Chek TD-3250). The cuff circumference is limited to 5.25" ~7.75" (13 ~20 cm) for wrist or 9.4"13.8" (2435 cm) for arm.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The document is a 510(k) summary for a medical device, which typically provides an overview of the device and its equivalence to predicate devices, rather than an in-depth scientific study.

However, based on the information available, I can extract what is mentioned:

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

The document broadly states that "The performance of the Clever Chek TD-3213... Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use."

It does not provide specific numerical acceptance criteria (e.g., accuracy percentages, precision metrics) or the reported device performance against those criteria. It only offers a general conclusion of satisfactory performance.

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

• Sample Size: Not specified for any test set.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The company address is in Taiwan, but this doesn't confirm the study location.

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 specified. The document mentions "healthcare professionals" participated in clinical settings, but no details on their number or qualifications for establishing ground truth are provided.

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

Not specified.

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. This device is a blood glucose and blood pressure monitoring system, not an AI-assisted diagnostic imaging device requiring human readers.

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

The device itself is a "standalone" measurement system for blood glucose and blood pressure in the sense that it provides direct readings without human interpretation of complex data (like an imaging algorithm). However, the document doesn't explicitly describe a "standalone performance study" in the context of an algorithm's performance vs. human interaction.

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

For blood glucose measurements, standard practice would involve comparison to a laboratory reference method (e.g., a YSI analyzer), which serves as the "ground truth." For blood pressure, a validated reference sphygmomanometer would be the ground truth. However, the document does not explicitly state what "ground truth" methods were used.

8. The sample size for the training set:

Not applicable or not specified. This device is not described as involving a machine learning algorithm that requires a "training set" in the conventional sense. Its function relies on electrochemical and oscillometric methods, not AI training.

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

Not applicable, as no training set for an AI algorithm is mentioned.

Summary of available information related to performance:

The document states:

• "The performance of the Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users."
• "The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use."
• "The Clever Chek TD-3213... Monitoring System demonstrates satisfactory performance and is suitable for their intended use."

This is a high-level summary confirming that performance studies were conducted and the device met its intended use, but it lacks the specific details of acceptance criteria and study methodologies requested.

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The Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use.

The system is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. 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 not intended for use on neonates.

The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

The CLEVER CHEK TD-3213TM blood glucose and blood pressure measurement system consists of a meter with wrist cuff 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. Also, the system adopts the "oscillometric method" to as the measuring principle and provides the measurement of the systolic and diastolic blood pressure and heart rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the wrist. The pressure sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to determine the systolic and diastolic blood pressure and calculating pulse rate.

I am unable to provide a comprehensive response as the provided text only offers a high-level summary of the device and its intended use, rather than a detailed performance study. The document states "The performance of the CLEVER CHEK TD-3213™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3213TM system is suitable for its intended use" and "The CLEVER CHEK TD-3213™ system demonstrates satisfactory performance and is suitable for their intended uses," but it does not include any specific data, acceptance criteria, sample sizes, or methodologies of these studies.

Therefore, I cannot extract the following information to populate the table and answer your questions:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs. without AI assistance. (This device is a blood glucose and blood pressure measurement system and does not mention any AI component, hence this question is likely not applicable).
• Whether a standalone (algorithm only) performance study was done. (Again, this device does not mention an algorithm in the context of interpretation beyond basic measurement).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

To provide a complete answer to your request, the full performance study report (or at least a detailed summary of its findings, acceptance criteria, and methodology) would be required.

Ask a specific question about this device