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The ACURA PLUS Multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA PLUS Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

The ACURA PLUS Multi Blood Glucose Monitoring System (BGMS) consists of an ACURA PLUS Multi Blood Glucose Meter, ACURA PLUS Multi Blood Glucose Test Strips, and ACURA PLUS Control Solutions with three different glucose concentrations ("Control 1", "Control 2", and "Control 3" ranges). The ACURA PLUS Multi BGMS are based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips. ACURA PLUS Control Solutions are used to test the performance of the system with a known range of glucose.

The provided text is a 510(k) summary for the ACURA PLUS Multi Blood Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed information about acceptance criteria, specific performance data from a study, sample size, data provenance, expert qualifications, adjudication methods, or specific details for training sets that you requested.

The document states: "Based on the submitted information in this premarket notification, the candidate device is substantially equivalent to the predicate device. Further, the candidate device has met the performance, safety, and effectiveness of the device for its intended use." This is a general statement of compliance, not a detailed report of a study meeting specific quantitative acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document, with the caveat that detailed performance results and acceptance criteria are not provided:

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

This information is not provided in the document. The document states a general conclusion that the device "met the performance, safety, and effectiveness of the device for its intended use" and is substantially equivalent to the predicate device, but does not list specific numerical acceptance criteria or corresponding device performance values.

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

This information is not provided for the blood glucose measurement performance. The only sample size mentioned relates to the disinfection study: "10,950 each of pre-cleaning and disinfection cycles for meter". Data provenance for this disinfection study is not explicitly stated beyond being performed "by an outside commercial testing service".

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

This information is not provided. The device measures glucose levels, which often uses a laboratory reference method as ground truth, not expert human assessment in the way an imaging device might.

4. Adjudication method for the test set

This information is not provided. As above, for a quantitative measurement device like a blood glucose meter, the ground truth is typically a direct measurement from a reference method, rather than an adjudicated expert consensus.

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

An MRMC study is not applicable and not mentioned. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging tool with human readers.

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

The device is a quantitative blood glucose monitoring system. Its "standalone" performance would be its accuracy in measuring glucose. While the document mentions the electrochemical biosensor technology, it does not provide details of accuracy studies with specific acceptance criteria and performance results.

7. The type of ground truth used

For blood glucose measurement systems, the ground truth is typically a laboratory reference method (e.g., YSI analyzer). This is implied by the nature of the device but not explicitly stated in the provided text.

8. The sample size for the training set

This information is not applicable as the device is not described as an AI/ML device that requires training data in the conventional sense. It's an electrochemical biosensor.

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

This information is not applicable as the device is not described as an AI/ML device that requires training data.

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