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The ACURA PLUS Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The ACURA PLUS Blood Glucose Meter is intended for use with the ACURA PLUS Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state blood glucose conditions. The ACURA PLUS Control Solutions are for use with the ACURA PLUS Meter and ACURA PLUS Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The ACURA PLUS Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis of or screening for diabetes.

The ACURA PLUS Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: ACURA PLUS Meter (Model GM505RA), ACURA PLUS Test Strips, ACURA PLUS Control Solutions for three different glucose concentration ranges (called "Low", "Normal" and "High" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.

The provided text highlights a 510(k) summary for the ACURA PLUS Blood Glucose Monitoring System. However, it does not contain detailed information about specific acceptance criteria for device performance, nor does it present a study that quantifies the device's performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through superficial changes (casing design, software modification for displaying averages) and stating that a "validation study was conducted" confirming these modified features operated properly.

Therefore, many of the requested details cannot be extracted from this document.

Here's an analysis of what can be extracted and what is missing:

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

This information is not provided in the document. The submission states "The test results confirmed that the modified features operated properly. Thus, ACURA PLUS BGMS demonstrated satisfactory performance and is suitable for its intended use." but does not give specific numerical acceptance criteria or the device's performance results against them.

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

This information is not provided in the document.

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 document. Blood glucose monitoring systems typically use laboratory reference methods (like hexokinase method) to establish ground truth, not expert consensus in the way a medical imaging device might.

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

This information is not provided in the document.

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 for human readers. Therefore, an MRMC study is not applicable and was not performed.

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

The device itself is a standalone system (meter and test strips). The statement "The test results confirmed that the modified features operated properly" implies performance testing was done on the device's functionality. However, specific standalone performance metrics (e.g., accuracy, precision) against a defined standard are not explicitly provided in terms of numerical results or how many samples were tested.

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

While not explicitly stated for this particular submission, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI analyzer which uses a glucose oxidase or hexokinase method) for glucose measurement. The document states a "validation study was conducted" but doesn't specify the ground truth method used.

8. The sample size for the training set

This information is not provided in the document. Given the nature of a blood glucose monitor, it's unlikely to have a "training set" in the machine learning sense. Performance validation would involve testing against known glucose concentrations or patient samples, but this is testing, not training.

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

As above, a "training set" in the machine learning sense is not applicable to this device.

Summary of available information:

The 510(k) submission for the ACURA PLUS Blood Glucose Monitoring System focuses on demonstrating substantial equivalence to its predicate devices (CareSens N Blood Glucose Monitoring System and ACURA Blood Glucose Monitoring System). The modifications were described as:

1. Meter outer casing design change.
2. Software modification for displaying averages stored in the meter's memory.

The document states: "To verify whether the modified feature operates correctly, the validation study was conducted. The test results confirmed that the modified features operated properly. Thus, ACURA PLUS BGMS demonstrated satisfactory performance and is suitable for its intended use." This indicates a study was performed to validate the changes, but no specific acceptance criteria or performance data from that study are included in this summary document. The submission concludes that the "modifications of ACURA PLUS BGMS do not affect the safety and effectiveness of the device and the intended use."

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