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The AP-1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010 Blood Glucose Test Strips must be used with the AP-1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

AP-1010multi Blood Glucose Monitoring System

The AP-1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010multi Blood Glucose Test Strips must be used with the AP-1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

AP-1020 Blood Glucose Monitoring System

The AP-1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020 Blood Glucose Test Strips must be used with the AP-1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

AP-1020multi Blood Glucose Monitoring System

The AP-1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020multi Blood Glucose Test Strips must be used with the AP-1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010 test strips and MAJOR control solution with the AP-1010 Blood Glucose Monitoring System.

The AP-1010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010multi test strips and MAJOR control solution with the AP-1010multi Blood Glucose Monitoring System.

The AP-1020 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020 test strips and MAJOR control solution with the AP-1020 Blood Glucose Monitoring System.

The AP-1020multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020multi test strips and MAJOR control solution with the AP-1020multi Blood Glucose Monitoring System.

The provided text is a 510(k) summary for the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring Systems. This document focuses on demonstrating substantial equivalence to a predicate device (AP-1000 Blood Glucose Monitoring System, K090389), rather than presenting a detailed de novo study with specific acceptance criteria and performance data for the current device.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this specific 510(k) summary because the submission relies on the established performance of the predicate device.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in this 510(k) summary. The submission asserts equivalence to a predicate device, implying that the performance data for the predicate device forms the basis of performance.
• Data Provenance: Not specified for any new testing for these specific devices. The previous 510(k) for the AP-1000 (K090389) would contain this information.

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

• This information is not applicable and not provided. Blood glucose monitoring systems typically use a laboratory reference method (e.g., YSI analyzer) as the ground truth, not expert consensus/adjudication.

4. Adjudication method for the test set

• Not applicable and not provided. Blood glucose measurements are quantitative and compared directly to a reference method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting results.

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

• The device is a standalone blood glucose monitoring system. Its performance is evaluated based on the accuracy of its glucose measurements compared to a laboratory reference. The submission explicitly states "Software verification and validation testing confirmed that the performance, safety and effectiveness... are equivalent to the predicate device." This implicitly refers to standalone performance.

7. The type of ground truth used

• While not explicitly stated for these specific modified devices in this document, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which is highly accurate and traceable to certified standards.

8. The sample size for the training set

• Not applicable and not provided. This is a medical device based on electrochemical biosensor technology, not an AI/ML model that requires a "training set" in the conventional sense. Software validation is mentioned, but not "training set."

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

• Not applicable (see point 8).

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves the device meets acceptance criteria" is implicitly the original 510(k) submission for the predicate device, AP-1000 Blood Glucose Monitoring System (K090389).

For the current submission (K103044), Bestgen Biotech Corporation performed testing (including "Software verification and validation testing") to demonstrate that the modifications to the AP-1010, AP-1010multi, AP-1020, and AP-1020multi systems did not change the "performance characteristics" of the device from its predicate. The modifications primarily involved "engineering change in the mechanical appearance of the device and name change."

The conclusion of this 510(k) states: "Based on the information provided in this submission, the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System is substantially equivalent to the predicate AP-1000 Blood Glucose Monitoring System." This means that the original performance data and acceptance criteria established for the AP-1000 are deemed sufficient to cover these modified devices due to their substantial equivalence. The document does not elaborate on new performance studies for these specific models.

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