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The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary, venous and arterial blood samples; lay use is limited to capillary whole blood testing.

Instrument Operating Principle -- photometry Reagent Test Principle -- glucose dehydrogenase

The provided text describes the Accu-Chek Go System for measuring glucose concentration in whole blood. However, it does not detail specific acceptance criteria with numerical targets (e.g., accuracy percentages, bias limits) or provide the full study results with specific performance metrics against those criteria. The document is a 510(k) summary, which typically provides a high-level overview.

Based on the provided text, here's what can be extracted and what information is missing:

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

The document mentions that "All predetermined acceptance criteria were satisfied," but it does not explicitly list the acceptance criteria or the specific reported device performance values for those criteria. It only states a general overarching acceptance:

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 the provided text. The document only mentions "A multi-center demonstrating substantial performance study was conducted."
• Data Provenance: Not specified. It only states a "multi-center" study. The terms "retrospective" or "prospective" are not used.

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)

Not specified. The ground truth was established by a "laboratory plasma glucose reference test method, Glucose Hexokinase." There is no mention of human experts establishing ground truth for the test set.

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

Not applicable, as the ground truth was established by a laboratory reference method, not by human experts requiring adjudication.

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 an in vitro diagnostic (glucose meter), not an imaging device or AI-assisted diagnostic tool that would involve "human readers" in the context of MRMC studies.

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

Yes, implicitly. The performance study evaluated the device's (Accu-Chek Go System) accuracy and precision directly against a laboratory reference method. This is a standalone performance assessment of the device, as it measures the device's output independently.

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

The ground truth used was a laboratory plasma glucose reference test method, specifically Glucose Hexokinase, with results converted to a plasma-like result.

8. The sample size for the training set

Not applicable. This device is a blood glucose meter, not a machine learning algorithm that typically requires a distinct "training set" in the context of AI/ML development. The "study" mentioned is a validation study for the device's performance.

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

Not applicable for the same reason as
point 8.

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