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The Clever Choice Voice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice Voice+ S Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Clever Choice Voice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose Test +S Test Strips are for use with the Clever Choice Voice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ S meters and Clever Choice +S Test Strips.

The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice + M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose +M Test Strips are for use with the Clever Choice Voice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.

The Clever Choice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice+ S Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Clever Choice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ S meters and Clever Choice +S Test Strips.

The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice Voice+ M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice Blood +M Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.

Clever Choice Voice+ S Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and the control solutions.

Clever Choice Voice+ M Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, multi use test strips, and the control solutions.

The four blood Glucose Monitoring system models are all based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing with their predicate device. The appearance is different from their predicate device. The new Blood Glucose Monitoring Systems have a function of ejecting the used test strip, which is also different from their predicate device.

The provided 510(k) summary for the Simple Diagnostics Clever Choice Blood Glucose Monitoring Systems states that performance testing was conducted according to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. However, the summary does not provide a detailed table of acceptance criteria or the specific reported device performance values against those criteria. It also lacks detailed information about the study design that would allow for a complete description of the elements requested in the prompt (sample sizes, expert qualifications, etc.).

Based on typical requirements for blood glucose monitoring systems and the information provided, here's an attempt to answer the questions, noting where information is missing:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states compliance with ISO 15197. This standard specifies accuracy criteria for blood glucose meters. Typical criteria for ISO 15197 are:

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The Clever Choice Voice + 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 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 this system can be used only during steady-state blood glucose conditions.

The Clever Choice Voice+ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only Clever Choice Voice+ Test Strips with the Clever Choice Voice + Blood Glucose Monitoring System.

The provided text is a 510(k) summary for the Clever Choice Voice + Blood Glucose Monitoring System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (like sample sizes for test/training sets, expert qualifications, or adjudication methods).

The document states:

• "Clever Choice Voice + Blood Glucose Monitoring System has the same performance characteristics as the predicate device."
• "A comparison of system accuracy performance demonstrated that the Clever Choice Voice + Blood Glucose Monitoring System and the FORA V20 Blood Glucose Monitoring System are substantially equivalent."
• "Software verification and validation testing confirmed that the performance, safety and effectiveness of the Clever Choice + Blood Glucose Monitoring System are equivalent to the predicate device."

This indicates that the manufacturer relies on the performance of the predicate device (FORA V20 Blood Glucose Monitoring System) to establish the performance of the Clever Choice Voice + system, rather than presenting a new, detailed performance study with explicit acceptance criteria. The modifications listed are primarily cosmetic (meter casing), software language, and unit selection, suggesting that the core analytical performance is considered identical to the predicate.

Therefore, many of the requested details about acceptance criteria and the study proving conformance cannot be extracted from this specific document.

If this were a submission for a novel device or one with significant changes to the measurement principle, these details would be critical. In this case, the FDA's acceptance of the 510(k) suggests they agreed with the manufacturer's argument of substantial equivalence based on the predicate's established performance, and the minor nature of the changes.

Missing Information:

• A table of acceptance criteria and the reported device performance: Not provided. The document claims "same performance characteristics" as the predicate but doesn't list specific metrics or acceptance criteria for either device.
• Sample sized used for the test set and the data provenance: Not provided. No specific test set data is mentioned for this device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This type of detail is typical for imaging or diagnostic interpretation devices, not for a blood glucose meter where ground truth is established by a reference laboratory method.
• Adjudication method: Not applicable/provided.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for devices requiring human interpretation.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a standalone algorithm, but no specific performance metrics are provided in this summary.
• The type of ground truth used: For blood glucose meters, ground truth is typically established by comparing the device's readings to a high-precision reference laboratory method (e.g., YSI analyzer). This is not explicitly stated but is standard for such devices.
• The sample size for the training set: Not provided.
• How the ground truth for the training set was established: Not provided.

In summary, this 510(k) submission leverages the substantial equivalence rule by asserting that the new device has the same performance characteristics as the predicate device due to minor, non-performance-affecting modifications. It does not present a de novo performance study against explicit acceptance criteria within this document.

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The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples 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 CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System cannot be used on neonates.

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

The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. The test principle of 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 whole blood and control solutions.

This 510(k) summary provides very limited information regarding the performance studies of the CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System. It states that the device has the "same performance characteristics as the predicate device" and that "studies of software verification and validation testing, method comparison, and meter reliability test demonstrated that the performance of systems meets the intended use." However, it does not provide any specific acceptance criteria or detailed results of these studies.

Therefore, for almost all of your requested information, the document explicitly states that the device has the 'same performance characteristics as' the predicate, but does not identify these characteristics, or describe tests that establish them. As a result, I must indicate that most of the criteria cannot be met based on the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device 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 for the test set: Not provided.
• Data provenance: Not provided (e.g., country of origin, retrospective/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 as no information on ground truth establishment by experts is provided for a test set.

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

• Not applicable as no details of a test set with expert adjudication are provided.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned. The device is a Blood Glucose Monitoring System, not an AI-assisted diagnostic tool for human readers.

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

• The document implies standalone performance of the blood glucose monitor through "method comparison, and meter reliability test," but it does not explicitly detail these studies or provide specific data regarding standalone performance. Without specific details on the "method comparison" test, it's impossible to confirm the algorithmic performance in isolation.

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

• Not explicitly stated for the "method comparison" studies. For blood glucose monitoring systems, ground truth is typically established by comparing results from the device to a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. However, the document does not specify the ground truth method.

8. The sample size for the training set

• Not provided. The document does not mention a "training set" in the context of machine learning, as this is a traditional medical device, not an AI/ML product. The studies mentioned ("software verification and validation testing, method comparison, and meter reliability test") are standard performance evaluations for such devices.

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

• Not applicable, as no training set (in the ML sense) is mentioned or implied.

Summary of the Study Information Provided in the Document:

The 510(k) submission for the CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System relies heavily on its substantial equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187). It states that the proposed device has the "same performance characteristics" as the predicate and that the "intended use, test principle, and operating technology" are the same. The only difference is an "engineering modification."

The performance studies mentioned are:

• Software verification and validation testing
• Method comparison
• Meter reliability test

The document concludes that these studies "demonstrated that the performance of systems meets the intended use." However, no specific details, data, acceptance criteria, or methodologies for these studies are provided within the given text. This level of detail is typically found in the full 510(k) submission and supporting documentation, which is not included here.

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The CLEVER CHOICE Mini 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 people with diabetes mellitus at home and by health care professionals in clinical settings 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 above system can be used only during steady-state blood glucose conditions.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only CLEVER CHOICE Mini test strips and CLEVER CHOICE control solutions with the CLEVER CHOICE Mini Blood Glucose Monitoring System.

The provided text is a 510(k) summary for the TaiDoc Technology Corporation's CLEVER CHOICE Mini Blood Glucose Monitoring System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, the document does not contain the detailed acceptance criteria or the specific study data that demonstrates the device meets such criteria.

The crucial section (Section 7, "Performance Characteristics") merely states: "CLEVER CHOICE Mini Blood Glucose Monitoring System has the same performance characteristics as the predicate device. A comparison of system performance demonstrated that the CLEVER CHOICE Mini blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System are substantially equivalent. Software verification and validation testing confirmed that the performance, safety and effectiveness of the CLEVER CHOICE Mini blood glucose monitoring system is equivalent to the predicate device."

This indicates that while performance testing was done, the actual criteria and reported results are not included in this summary. The submission relies on demonstrating equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187) rather than providing a detailed de novo performance study with specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's an attempt to answer what can be inferred or, more importantly, what is missing:

Acceptance Criteria and Device Performance Study Report

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information (Based on what is and is not in the provided text):

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

• Sample size: Not specified.
• Data provenance: Not specified. Given it's a Taiwanese company, it's possible the data originated from Taiwan, but this is not stated. The type of study (retrospective or prospective) is also not specified.

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

• Not applicable / Not provided. For a blood glucose monitoring system, the "ground truth" (reference method) is typically established by laboratory-grade analyzers (e.g., YSI glucose analyzer) rather than expert consensus on images or interpretations. The document does not specify the reference method used or any experts involved in establishing ground truth.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or subjective interpretations. For a blood glucose meter, the "truth" is typically determined by an objective, highly accurate reference laboratory method. No such adjudication method is relevant or described for this type of device.

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:

• No. This is a blood glucose monitoring system, not an AI-powered diagnostic imaging device. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are not applicable.

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

• Not applicable in the AI sense. The device itself is a standalone measurement system. The performance referred to is the accuracy of the glucose measurement by the system (meter + strip). It's an "algorithm only" in the sense that the device outputs a numerical result without human interpretation of the measurement process itself, but it's not an AI algorithm determining a diagnosis or interpreting images. The closest information is that "Software verification and validation testing confirmed that the performance, safety and effectiveness...".

7. The type of ground truth used:

• Not specified. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., a YSI analyzer measuring plasma glucose), but this document does not explicitly state the reference method used in the performance comparison.

8. The sample size for the training set:

• Not applicable / Not provided. This device is based on electrochemical biosensor technology, not a machine learning model that requires a distinct "training set" in the conventional AI sense. While the device's algorithms are developed and refined, the concept of a "training set" as understood in AI studies is not directly applicable or described here.

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

• Not applicable / Not provided. As mentioned above, the concept of a training set with established ground truth, as typically discussed for AI/ML devices, does not apply to this electrochemical blood glucose meter in the context of this 510(k) summary.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria. The specific numerical performance, sample sizes, and detailed methodology of the performance study are not included in this document.

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