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The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary 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 and venous blood samples; lay use is limited to capillary whole blood testing.

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

Here's a breakdown of the acceptance criteria and study information for the Accu-Chek Go System based on the provided 510(k) summary:

The document states that a multi-center performance study was conducted to evaluate the accuracy and precision of the modified device, and all predetermined acceptance criteria were satisfied. However, the document does not explicitly list the specific acceptance criteria or the reported device performance in a table format. It only states that the device "correlates well with the laboratory plasma glucose reference test method." More detailed information regarding the specific criteria (e.g., specific bias percentages, error grid analysis zones, or precision CVs) and the performance results would typically be found in the full study report, which is not provided here.

Therefore, the table below uses the information available in the provided text, acknowledging that the specific performance metrics for the acceptance criteria are not detailed.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary explicitly states that "All predetermined acceptance criteria were satisfied," but does not detail the quantitative cutoffs for these criteria or the specific performance metrics achieved (e.g., specific bias percentages, error grid analysis zones, or precision CVs).

2. Sample Size and Data Provenance for the Test Set

The document does not specify the exact sample size used for the test set. It only mentions "A multi-center performance study was conducted."

Regarding data provenance, the document indicates:

• Country of Origin: Not explicitly stated, but given Roche Diagnostics Corporation's location (Indianapolis, IN) and the FDA approval process, it's highly likely that at least some, if not all, of the data originated from the United States.
• Retrospective or Prospective: Not explicitly stated. However, "A multi-center performance study was conducted" generally implies a prospective study where data is collected specifically for the purpose of the device evaluation.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not provide information on:

• The number of experts used to establish the ground truth for the test set.
• The qualifications of those experts.
• Given the nature of a glucose meter, the "ground truth" is typically established by laboratory reference methods rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. This is generally not relevant for quantitative medical devices like blood glucose meters where the ground truth is established by a quantitative laboratory reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for a standalone glucose meter. MRMC studies are typically used for imaging interpretation devices where human readers interpret medical images, and the study assesses the impact of AI assistance on their diagnostic performance. This device is a standalone quantitative measurement system.

6. Standalone (Algorithm Only) Performance

Yes. The study conducted was a standalone performance study of the Accu-Chek Go System. The glucose meter itself (the "algorithm" in this context) directly measures and reports glucose concentration without human interpretation in the results generation process. The summary explicitly states: "Performance testing on the modified Accu-Chek Go System demonstrated that the device meets the performance requirements for its intended use." This focuses on the device's intrinsic accuracy and precision compared to a reference method.

7. Type of Ground Truth Used

The ground truth used was laboratory plasma glucose reference test method. The document states that the device's performance "correlates well with the laboratory plasma glucose reference test method." This indicates that the device's readings were compared against an established, highly accurate laboratory instrument.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. For medical devices, especially quantitative ones, the "training set" might refer to data used during the development and calibration phases of the device, rather than a distinct, separate dataset used for machine learning model training in the AI sense.

9. How the Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth was established for a training set. Similar to point 8, if a "training set" was used for calibration or development, the ground truth would likely have been established using a laboratory reference method, consistent with how the test set ground truth was determined.

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