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The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-300 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 GoodLife AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-301 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 GoodLife AC-301 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-302 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 GoodLife AC-302 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-303 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 GoodLife AC-303 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-303 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-304 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 GoodLife AC-304 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-305 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 GoodLife AC-305 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-305 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control.

The GoodLife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-300 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control.

The GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-301 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control.

The GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-302 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control.

The GoodLife AC-303 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-303 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control.

The GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-304 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-305 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

GL GoodLife Series Blood Glucose Monitoring System consists of: (1) Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, AC-304, AC-305), (2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307, (3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307, (4) Check Strip, (5) Instruction for use. GL GoodLife Series Professional Blood Glucose Monitoring System consists of: Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, AC-304, AC-305), (2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307, (3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307, (4) Check Strip, (5) Instruction for use. These models have the same intended use and technological characteristics except the housing of the meter. Although the different shapes of housing, the materials are the same.

The provided document is a 510(k) summary for the GoodLife AC-300 series Blood Glucose Monitoring Systems. It claims substantial equivalence to a predicate device (K113307) based on meeting performance requirements.

Here's a breakdown of the requested information, extracted from the document:

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

The document does not explicitly present a table of acceptance criteria and reported device performance. It only states that the device "met pre-determined acceptance criteria" and "fulfilled the requirements from those standards mentioned above." The exact standards and specific performance metrics (e.g., accuracy percentages per glucose range) are not detailed within this summary.

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

The document mentions "results of testing performed to validate changes to the system met pre-determined acceptance criteria," implying a test set was used, but it does not provide any information regarding the sample size of the test set or the data provenance (country of origin, retrospective/prospective nature).

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)

The document does not provide any information about the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not subjective expert consensus.

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

The document does not provide any information about an adjudication method for the test set. For objective measurements like blood glucose, adjudication would not typically be applicable in the way it is for image interpretation.

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 AI-assisted diagnostic imaging device that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers is not applicable and was not performed.

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

Yes, this is a standalone device. The "algorithm" (the electrochemical biosensor system) provides the measurement directly without human subjective interpretation. The document describes it as an electrochemical biosensor system that measures and displays the result directly.

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

While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth is established by comparison to a recognized laboratory reference method (e.g., a YSI analyzer). The regulatory review for such devices always requires this comparison, and the phrase "met pre-determined acceptance criteria" would implicitly refer to such a comparison.

8. The sample size for the training set

This device is not an AI/machine learning model in the conventional sense that would require a "training set." It is an electrochemical biosensor. Therefore, the concept of a training set is not applicable. The device's performance is determined by its engineering, chemical reagents, and calibration processes.

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

As the concept of a training set is not applicable for this type of device, this information is not relevant. The device's calibration is achieved by an implicit coding process when the test strip is inserted, which incorporates parameters to calculate the glucose value (page 17).

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The FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared.

The FlA Blood Glucose Monitoring System (G2) 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 FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The FIA Blood Glucose Test Strips (G2) are for use with the FIA Blood Glucose Meter (G2) to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The FIA Glucose Control Solutions are for use with the FIA Blood Glucose Meter (G2) and FIA Blood Glucose Test Strips (G2) to check that the meter and test strips are working together properly and that the test is performing correctly.

FIA Blood Glucose Monitoring System (G2) consists of:
(1) Glucose Meter
(2)Glucose Test Strips
(3)Two levels of glucose control solutions (L1 and L2) may be purchased separately. Glucose control solutions were previously cleared under K032985.
(4)Check Strip
(5)Instruction for use

FIA Blood Glucose Monitoring System (G2) is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.

The FIA Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the FIA Blood Glucose monitoring system (G2) and FIA Blood Glucose Test strips (G2). There are two levels of controls (L1 and L2).

The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.

The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The document states that the FIA Blood Glucose Monitoring System (G2) is compliant with the standard ISO 15197:2003 In vitro diagnostic test systems-Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. However, the exact numerical acceptance criteria from this standard and the specific reported device performance against those criteria are not explicitly detailed in the provided text.

The document only makes a general statement: "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met."

To properly answer this section, one would typically expect a table like this:

Without the actual numerical performance data and specific ISO 15197:2003 criteria, a detailed table cannot be populated.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for the Test Set: Not explicitly stated in the provided text. The document mentions "clinical tests" were performed, but does not specify the number of blood samples or participants involved.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the clinical tests were performed by "professionals."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not provide any information about the number of experts used or their qualifications to establish ground truth. For blood glucose monitoring systems, ground truth is typically established by comparing results to a laboratory reference method (e.g., YSI analyzer), rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set:

• The document does not mention any adjudication method for the test set. Given that this is a blood glucose monitoring system, the "ground truth" would usually be established by a laboratory reference method, implying a direct comparison rather than a separate adjudication process by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The FIA Blood Glucose Monitoring System (G2) is an in vitro diagnostic device for self-testing blood glucose, where the output is a numerical value directly from the device, not an interpretation by a human reader. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

• Yes, in spirit, the primary performance evaluation described is standalone. The device itself (meter and test strip) is designed to provide a direct quantitative measurement of glucose. The "clinical tests" performed against ISO 15197:2003 evaluate the accuracy of the device's measurements relative to a reference method, which is essentially its standalone performance. There isn't a "human-in-the-loop" component in the sense of a human interpreting the device's output and then having that interpretation evaluated.

7. Type of Ground Truth Used:

• The document implies that the ground truth for the clinical tests was based on a reference method to which the device's measurements were compared, aligning with the requirements of ISO 15197:2003. For blood glucose monitors, this is typically a laboratory reference method (such as a YSI glucose analyzer) that provides highly accurate glucose concentration values. The text doesn't explicitly name the reference method, but states compliance with a standard designed for such comparisons.

8. Sample Size for the Training Set:

• The document does not provide any information about a training set size. For a blood glucose monitoring system, the "training set" would refer to data used for the initial development and calibration of the device's algorithm, which is typically an internal process and not usually detailed in a 510(k) summary in this manner. The focus here is on the verification and validation of the final product.

9. How the Ground Truth for the Training Set Was Established:

• The document does not provide any information on how the ground truth for a training set (if one was formally defined for algorithm development) was established. As mentioned above, for this type of device, it would generally involve comparison to a laboratory reference method.

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The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GoodLife CS-200 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 GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.

The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and intended for multiple-patient use in professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.

The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips

GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist of:

• (1) Glucose Meter
• (2) Glucose Test Strips
• (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
• (4) Check Strip
• (5) Instruction for use

[Test Principle]

The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.

[Control Solution]

The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System and GoodLife KP & GoodLife KP Professional Blood Glucose Test strips. There are two levels of controls (Levels 1, 2).

[Check Strip]

The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.

[Device Calibration]

The device is calibrated by Digital Code Strip. While inserting the Digital Code Strip into the coding slot, the meter will turn on automatically and complete the coding. The meter will apply formula including this parameter of code to calculate the glucose value.

This 510(k) summary provides limited details regarding the specifics of the clinical study, making it challenging to fully address all requested information. However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states compliance with ISO 15197:2003. This standard defines acceptance criteria for blood glucose monitoring systems. While the specific numerical acceptance criteria from the standard are not explicitly listed in this document, the submission claims that "the predetermined acceptance criteria were fully met." Without access to the full study report or the ISO 15197:2003 standard, the exact numerical performance metrics for the device against specific thresholds cannot be detailed.

Acceptance Criteria (Based on ISO 15197:2003 Claims):

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided 510(k) summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The submission is from a Taiwan-based company, which might suggest data could originate from Taiwan or other regions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not explicitly stated in the provided 510(k) summary. For blood glucose monitoring systems, the ground truth is typically established using a reference laboratory method (e.g., YSI analyzer), not necessarily by "experts" in the same way as image interpretation.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for blood glucose monitoring systems. The "ground truth" is typically a quantitative measurement from a reference method, rather than a subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not relevant or typically performed for blood glucose monitoring systems. These studies are common for diagnostic imaging devices where human interpretation plays a significant role.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the device (GoodLife CS-200 Blood Glucose Monitoring System) is a standalone system. Its performance is measured directly by comparing its readings to a reference method, without human intervention in the result generation or interpretation. The submission states, "The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor." This describes a standalone, automated measurement.

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., a glucose analyzer, often a YSI analyzer), which provides a highly accurate and precise measurement of blood glucose. While not explicitly stated as "YSI" in this document, the industry standard for studies supporting ISO 15197 compliance relies on such reference methods. This falls under the category of reference standard/laboratory measurement.

8. The Sample Size for the Training Set

Not applicable and not typically mentioned for this type of device. Blood glucose meters do not usually involve a "training set" in the context of machine learning algorithms that learn from data. The device's calibration and algorithm are developed through engineering and chemical principles, not machine learning training. The "calibration" mentioned ("The device is calibrated by Digital Code Strip...") refers to a specific operational calibration for each batch of test strips, not a machine learning training process.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there isn't a "training set" in the machine learning sense for this device. The device's design, chemical reagents, and electrochemical principles are developed and validated against known glucose concentrations and reference methods during its R&D phase, but this is not framed as establishing ground truth for a "training set."

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The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by health care professionals in a clinical setting:

The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The PRECICHEK KP Blood Glucose Test Strip is for use with the PRECICHEK NS-101 POCT Professional Blood Glucose Meter to quantitatively measure glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples.

The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System consists of:

• (1) Glucose Meter
• (2) Glucose Test Strips
• (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
• (4) Check Strip
• (5) Instruction for use

[Test Principle]
The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor.

When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.

[Control Solution]
The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips. There are two levels of controls (Levels 1,2).

[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.

[Device Calibration]
The device is calibrated by implicit coding process. The code number is the last two digits of the strip lot number. The user should input the strip lot number into the memory of the meter before use.

While performing the blood glucose test, the strip lot number printed on the vial label is scanned to match the one in the memory. The meter will apply formula including this parameter to calculate the glucose value.

The provided 510(k) summary (K113314) describes the PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System. The summary states that the device's performance was evaluated against the standard ISO 15197:2003.

Here's the breakdown of the information requested:

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

The summary explicitly states that the device is compliant with ISO 15197:2003 for in vitro diagnostic test systems for blood glucose monitoring. The key performance criteria from this standard (and assuming the device met them as stated in the summary) are:

Note: The summary states, "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met." However, it does not provide the numerical performance data in terms of specific percentages, standard deviations, or bias values. It only provides a general statement of compliance with the ISO standard.

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

The summary does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions that compliance with ISO 15197:2003 was demonstrated. This standard typically requires a minimum number of samples for accuracy evaluation (e.g., at least 100 patient samples with a distribution across the measuring range).

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)

This information is not provided in the summary. For blood glucose monitoring systems, the "ground truth" (reference method) is typically established by laboratory-based glucose analyzers, not by human experts in the same way as imaging diagnostics.

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

This information is not applicable and therefore not provided in the summary. Adjudication methods like "2+1" are relevant for expert review of medical images or clinical cases, not for objective biochemical measurements like blood glucose.

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 information is not applicable and therefore not provided in the summary. The device is a blood glucose monitoring system, not a diagnostic imaging AI tool that assists human readers.

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

Yes, the study performed was a standalone performance evaluation of the device. The PRECICHEK NS-101 POCT system is designed to provide a direct quantitative measurement of glucose, without human interpretation in the loop to determine the glucose value itself (though human users operate the device and interpret the numerical result). The stated compliance with ISO 15197:2003 directly assesses the accuracy and performance of the device itself.

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

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method, such as a hexokinase or glucose oxidase method on a high-precision clinical chemistry analyzer. While not explicitly stated, compliance with ISO 15197 suggests that the device's measurements were compared against such a validated reference method.

8. The sample size for the training set

This information is not applicable and therefore not provided in the summary. The device in question is a biosensor-based system for direct measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its calibration is described as an "implicit coding process" based on strip lot numbers, which is a manufacturing calibration rather than algorithm training.

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

This information is not applicable as there is no "training set" for an algorithmic model in the context of this device. The device's calibration mechanism ("implicit coding process") is described as matching a strip lot number to a formula in the meter, which is a factory-set calibration, not a learned model based on a ground-truthed training set.

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The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The PRECICHEK Cloudia 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 PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

PRECICHEK Cloudia Blood Glucose Monitoring System consists of:

• (1)Glucose Meter
• (2)Glucose Test Strips
• (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
• (4)Check Strip
• (5)Instruction for use

[Test Principle]

PRECICHEK Cloudia Blood Glucose Monitoring System is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.

[Control Solution]

The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the PRECICHEK Cloudia Blood Glucose monitoring system and PRECICHEK ACH Blood Glucose Test strips. There are two levels of controls (Levels 1,2).

[Check Strip]

The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.

[Device Calibration]

The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.

The PRECICHEK Cloudia Blood Glucose Monitoring System acceptance criteria and study information are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the device is compliant with ISO 15197:2003. This standard specifies requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. Therefore, the acceptance criteria are those defined by ISO 15197:2003. While the specific numerical performance metrics are not detailed in the provided text, the overall statement of compliance implies that the device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the test set. It also does not provide details on the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts used to establish the ground truth or their qualifications. It only states, "All the relevant activities were performed by professionals."

4. Adjudication Method for the Test Set:

The document does not describe the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention of an MRMC comparative effectiveness study or any effect size regarding human readers improving with AI vs without AI assistance. This device is a blood glucose monitoring system and does not involve AI assistance for human readers in diagnostic interpretation.

6. Standalone Performance Study:

Since this is a blood glucose monitoring system, the performance described relates to the accuracy and precision of the device itself (algorithm only without human-in-the-loop diagnostic interpretation). The document indicates that the device's performance was evaluated against the ISO 15197:2003 standard, which assesses the standalone performance of the system for measuring glucose.

7. Type of Ground Truth Used:

The ground truth for evaluating the PRECICHEK Cloudia Blood Glucose Monitoring System would typically be established by a reference laboratory method (e.g., a laboratory glucose analyzer) that is traceable to an accepted standard, as per the ISO 15197:2003 guidelines for blood glucose meters. While not explicitly stated, this is the standard practice for such devices.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. For a medical device like a blood glucose meter, the "training set" would likely refer to the data used during the development and calibration phases, rather than a distinct 'training set' in the machine learning sense. This detail is not provided.

9. How the Ground Truth for the Training Set was Established:

The document does not provide details on how the ground truth for any potential "training set" was established, beyond the general adherence to ISO 15197:2003 for performance evaluation. Calibration of blood glucose meters typically involves comparing the device's readings against highly accurate laboratory reference methods across a range of glucose concentrations.

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For single use-
GoodLife AC-300 Blood Glucose Monitoring System
The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-300 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 GoodLife AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-300 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-301 Blood Glucose Monitoring System
The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-301 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 GoodLife AC-301 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-302 Blood Glucose Monitoring System
The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-302 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 GoodLife AC-302 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-303 Blood Glucose Monitoring System
The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-303 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 GoodLife AC-303 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-303 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-304 Blood Glucose Monitoring System
The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-304 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 GoodLife AC-304 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-305 Blood Glucose Monitoring System
The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-305 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 GoodLife AC-305 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-305 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

For multiple use-
GoodLife AC-300 Professional Blood Glucose Monitoring System
The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-300 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-300 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-301 Professional Blood Glucose Monitoring System
The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-301 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-302 Professional Blood Glucose Monitoring System
The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-302 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-303 Professional Blood Glucose Monitoring System
The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-303 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-303 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-304 Professional Blood Glucose Monitoring System
The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-304 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-305 Professional Blood Glucose Monitoring System
The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-305 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-300305 Blood Glucose Monitoring System and GoodLife AC-300305 Professional Blood Glucose Monitoring System consist of:
(1)Glucose Meter
(2)Glucose Test Strips
(3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
(4)Check Strip
(5)Instruction for use
These models have the same intended use and technological characteristics except the housing of the meter. Although the different shapes of housing, the materials are the same.
[Test Principle]
GoodLife AC-300305 Blood Glucose Monitoring System and GoodLife AC - 300305 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) to assess the performance of the GoodLife AC-300305 with GoodLife AC Blood Glucose Test strips or AC-300305 Professional Blood Glucose monitoring system with AC Professional Blood Glucose Test strips. There are two levels of controls (Levels 1,2).
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.

The document describes several GoodLife AC-300~305 blood glucose monitoring systems and their professional counterparts. The acceptance criteria and the study proving the device meets them are outlined, primarily referring to consistency with ISO 15197:2003.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device claims compliance with ISO 15197:2003. This international standard sets the requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. While the document does not explicitly list the detailed clauses of ISO 15197:2003 as acceptance criteria, it states that the device is "compliant to the standard" and that "the results demonstrated that the predetermined acceptance criteria were fully met."

Therefore, the acceptance criteria are implicitly those defined by ISO 15197:2003. The document does not provide specific numerical performance metrics from the study to directly compare against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The studies cited (CLSI/NCCLS EP05-A2, EP06-A, EP07-A2, EP09-A2) are guidelines for evaluating the performance of quantitative measurement methods, implying that an established reference method (often laboratory-based) would serve as the ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For quantitative measurements like blood glucose, adjudication among multiple human readers is typically not applicable in the same way it would be for qualitative assessments (e.g., image interpretation). Instead, the device's readings are compared against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or subjective assessments where multiple human readers interpret cases. Blood glucose monitoring systems are quantitative measurement devices not typically evaluated with MRMC studies in this context. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance described for the blood glucose monitoring system is inherently a standalone performance. The device provides a quantitative measurement of glucose. A "human-in-the-loop" would involve interpretation or decision-making aided by the device's output, but the device's core function is the measurement itself. The studies performed (e.g., accuracy, precision, linearity) evaluate this standalone measurement capability. Therefore, yes, a standalone performance evaluation was done.

7. The Type of Ground Truth Used

Based on the nature of blood glucose monitoring and the CLSI standards referenced, the ground truth would typically be established by a highly accurate laboratory reference method for glucose measurement. The document states a "reference method" is used, which is standard practice in these types of evaluations. The CLSI/NCCLS EP09-A2 standard explicitly deals with "Method Comparison and Bias Estimation Using Patient Samples," which involves comparing the device's results to a more established, accurate method.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. Blood glucose meters are calibrated implicitly during the manufacturing process and through quality control rather than through an "AI training set" in the conventional sense of machine learning algorithms. The calibration involves applying a formula that includes a code parameter specific to the test strip.

9. How the Ground Truth for the Training Set Was Established

The device is calibrated by an "implicit coding process" that occurs when a test strip is inserted. This suggests a pre-programmed calibration based on manufacturing specifications and quality control data rather than a dynamic ground truth established for a "training set" in the machine learning context. The document does not detail how the ground truth for this initial calibration was established, but it would typically involve rigorous laboratory testing against reference methods during the device and strip development and manufacturing stages.

Ask a specific question about this device

The GlucoLeader Enhance Self-Monitoring of Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

The GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System is comprised of two main parts a bio-active electrode (test strip) containing the enzyme glucose oxidase and the glucose meter. The blood sample is drawn into the Test Strip through capillary action. Glucose in the sample reacts with glucose oxidase and potassium ferricyanide in the strip, producing ferrocyanide. Potassium ferrocyanide is produced in proportion to the glucose concentration of the blood sample. Oxidation of the potassium ferrocyanide produces an electrical current which is then converted by the meter to display the glucose concentration.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated in terms of specific performance thresholds (e.g., a certain percentage of readings within a specific range). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (GlucoLeader™ Value Self-Monitoring of Blood Glucose System) through strong correlation.

Therefore, the "acceptance criteria" inferred from the document is the demonstration of a strong linear correlation (R > 0.98) and low standard error of the estimate (Sy.x) within the specified glucose measurement range (40-400 mg/dL or 64-539 mg/dL) when compared to a reference method (YSI) for lay users and technicians, and when compared to the predicate device (GlucoLeader™ Value) in point-of-care settings.

2. Sample Size Used for the Test Set and Data Provenance

• Consumer Study:
  • Sample Size: 180 specimens for lay users and 180 specimens for technicians.
  • Data Provenance: Conducted at "clinical centers." The country of origin is not explicitly stated, but the submitter is HMD Biomedical Inc. from Taiwan. The mention of "clinical centers" suggests a prospective collection for this study, though it's not explicitly stated as "prospective."
• Point-Of-Care Study:
  • Sample Size: 150 specimens (50 each from Home Medical, Metabolism, and Internal departments).
  • Data Provenance: Conducted at "department of Home Medical, Internal, and Metabolism." Similar to the consumer study, the country of origin is not explicitly stated. This appears to be prospective data collection in a clinical setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Ground Truth Method: The primary ground truth for the consumer study was established using the YSI (Yellow Springs Instruments) method, which is a laboratory reference method for glucose measurement. For the point-of-care study, the predicate device, GlucoLeader™ Value, served as the comparative reference.
• Experts: The document does not specify a "number of experts" in the context of establishing ground truth for the test set by consensus or interpretation (e.g., radiologists). The ground truth was primarily obtained via instrument-based reference methods (YSI) and the predicate device. For the "technician" comparison in the consumer study, it's implied that trained medical technicians operated the GlucoLeader Enhance device and that their readings were compared to the YSI reference. Their qualifications are not further detailed beyond "technician."

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by objective measurements from reference instruments (YSI) or by comparison to the predicate device, not through expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes studies to evaluate the standalone performance and substantial equivalence of a glucose meter, not a comparative effectiveness study involving multiple human readers using an AI vs. without AI assistance. The device is a self-monitoring blood glucose system, not an AI diagnostic tool that assists human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies presented are essentially standalone performance evaluations of the GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System.

• The "Consumer Study" compares the device's output (when used by lay users or technicians) directly against a definitive reference method (YSI).
• The "Point-of-Care Study" compares the device's output against a predicate device.

In both cases, the performance being assessed is that of the device itself.

7. Type of Ground Truth Used

• Consumer Study Ground Truth: Objective reference method measurements from a YSI instrument (a laboratory analyzer for glucose).
• Point-of-Care Study Ground Truth: Comparative measurements from the GlucoLeader™ Value predicate device.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or how the device's algorithms (if any beyond basic signal processing and conversion) were developed or trained. This submission focuses on the performance of a final, manufactured device. Glucose meters typically use pre-calibrated algorithms established during development, not "trained" in the machine learning sense on a distinct training dataset for each submission.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set information is provided or implied for this type of device in the document.

Ask a specific question about this device

For the quantitative measurement of glucose levels in human whole blood by people with diabetes at home and by health care workers in a professional setting.

Not Found

I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria, study details, and performance of the HMD Biomedical GlucoLeader™ Blood Glucose Test System. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not include the specifics of the performance study or clinical trial results.

To answer your request, I would need a document such as a clinical study report, a detailed summary of safety and effectiveness, or the full 510(k) submission which would typically contain such information. This current document only states that the device is cleared for marketing based on substantial equivalence.

Ask a specific question about this device