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The AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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-2000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling 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-2010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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-2010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling 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-2020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) (OTC) by a single patient with diabetes and should not be shared, as an 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-2020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling 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-2000 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-2000 test strips and MAJOR control solution with the AP-2000 Blood Glucose Monitoring System.

The AP-2010multi 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-2010multi test strips and MAJOR control solution with the AP-2010multi Blood Glucose Monitoring System.

The AP-2010 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-2010 test strips and MAJOR control solution with the AP-2010 Blood Glucose Monitoring System.

The AP-2010multi 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-2010multi test strips and MAJOR control solution with the AP-2010multi Blood Glucose Monitoring System.

The AP-2020 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-2020 test strips and MAJOR control solution with the AP-2020 Blood Glucose Monitoring System.

The AP-2020multi 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-2020multi test strips and MAJOR control solution with the AP-2020multi Blood Glucose Monitoring System.

This 510(k) summary does not contain sufficient information to directly answer all components of your request, specifically regarding detailed acceptance criteria, the study design, and sample sizes for training and testing as typically found in comprehensive clinical/performance studies.

The document is a 510(k) summary for new glucose monitoring systems (AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi), stating their substantial equivalence to a predicate device (AP-1000 Blood Glucose Monitoring System, K090389). It emphasizes that the new devices have the "same performance characteristics as the predicate device" and that "A comparison of system accuracy performance demonstrated that... [new devices]... are substantially equivalent." This implies that the acceptance criteria and performance data for the new devices are considered to be met by virtue of their equivalence to the predicate device, for which performance data presumably exists elsewhere.

However, based on the provided text, here's what can be extracted and inferred:

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

The document states that the "AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." It also states, "A comparison of system accuracy performance demonstrated that... [the new devices]... are substantially equivalent."
Since no explicit acceptance criteria or detailed performance results are provided in this 510(k) summary for the new devices beyond this statement of equivalence, we must infer that the acceptance criteria and reported performance would be those met by the predicate device (AP-1000). Without the predicate's performance data, specific numbers are unavailable from this document.

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

• Sample Size for Test Set: Not specified in this document. The submission relies on demonstrating "substantial equivalence" to a predicate device rather than presenting new detailed performance study data for the new devices themselves.
• Data Provenance: Not specified.

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 applicable as the device is a Blood Glucose Monitoring System, which measures a quantitative biochemical marker. The "ground truth" for glucose measurements would typically be established by a laboratory reference method (e.g., hexokinase method) rather than expert human consensus on image or clinical interpretation.

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

This is not applicable for a quantitative blood glucose measurement device. Adjudication methods are relevant for subjective interpretations (e.g., radiology reads) that require consensus among experts.

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 not applicable. An MRMC study is relevant for imaging or diagnostic interpretation tasks involving human readers, typically in conjunction with AI assistance. This device is a standalone in-vitro diagnostic device for quantitative glucose measurement.

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

The performance characteristics mentioned are for the "AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System," which is an integrated system (meter, test strips, control solutions). The "system accuracy performance" mentioned implies a standalone performance evaluation of the device itself. No human-in-the-loop interaction for interpretation (like with AI tools) is suggested, as it provides a direct quantitative reading.

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

While not explicitly stated in this document, for blood glucose monitoring systems, the "ground truth" would almost certainly be established by a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods using a central lab analyzer), not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified. This submission focuses on "substantial equivalence" to a predicate, not on a de novo device with an explicit training dataset. The device is a hardware/software system, and "training set" would typically refer to data used to develop or calibrate the algorithm, which is not detailed here.

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

• This information is not specified in the provided document. If a training set was used for algorithmic development, the ground truth would similarly be established by a laboratory reference method, as mentioned in point 7.

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