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The OneTouch® Verio® Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be shared.
The OneTouch® Verio® Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The OneTouch® Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

Here's a breakdown of the acceptance criteria and study information for the OneTouch Verio Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document specifically refers to ISO 15197:2003(E) as the standard for performance testing. While ISO 15197:2003(E) has specific accuracy criteria (e.g., a certain percentage of results within ±X mg/dL or ±Y%), the summary text reports the device's performance against those criteria rather than explicitly stating the criteria as acceptance thresholds separate from the results. However, we can infer the acceptance criteria from the reported performance, as reaching 100% within certain thresholds implies these were the targets.

Note: While the results are high, the table does not explicitly state 100% for these user performance categories, so we cannot infer 100% as the acceptance criterion from the provided text for user performance.

2. Sample Size Used for the Test Set and Data Provenance:

• System Accuracy Test Set Sample Sizes:
  • Glucose < 75 mg/dL: 69 samples
  • Glucose ≥ 75 mg/dL: 231 samples
• User Performance Evaluation Test Set Sample Sizes:
  • Glucose < 75 mg/dL: 20 samples
  • Glucose ≥ 75 mg/dL: 169 samples
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were conducted as part of design verification and validation testing for the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• The document mentions comparison to a "laboratory reference method, the Yellow Springs Instrument (YSI)". This indicates that the ground truth was established by a validated laboratory method, not by human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" does not apply in this context.

4. Adjudication Method for the Test Set:

• Not applicable, as the ground truth was established by a laboratory reference instrument (YSI), which provides a quantitative measurement, not a subjective interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not conducted with human readers improving with AI vs without AI assistance. This device is a blood glucose meter, and its performance is evaluated against a reference laboratory method, not against human interpretation of images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance:

• Yes, the "System Accuracy" section reports the performance of the device (meter) directly against the laboratory reference method, which is a standalone assessment of the algorithm/device. The "User Performance Evaluation" also assesses the device, but in the hands of intended users, which is slightly different but still focuses on the device's accuracy.

7. Type of Ground Truth Used:

• The type of ground truth used was a laboratory reference method (Yellow Springs Instrument - YSI). This is a quantitative, highly accurate measurement system often considered the gold standard for glucose concentration.

8. Sample Size for the Training Set:

• The document does not explicitly state a separate "training set" sample size. For in vitro diagnostic devices like blood glucose meters, the development and calibration typically involve extensive data, but the 510(k) summary focuses on the performance verification using a distinct test set. The precision data (Within Run Precision with 300 venous blood tests per glucose level, and Total Precision with 600 control solution tests at each level) could be considered part of the data used for device development and characterization, but not explicitly as a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established:

• As a dedicated "training set" is not explicitly mentioned in the context of machine learning model training, this question is not directly applicable. However, the overall development and calibration of the glucose meter would rely on a robust ground truth established by laboratory reference methods (like the YSI) to ensure accurate measurements across various glucose concentrations, similar to how the test set ground truth was established.

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