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The OneTouch Ultra Plus Flex 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 fingertip. The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The OneTouch Ultra Plus Flex 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 Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus Flex Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

The OneTouch Ultra Plus Flex Blood Glucose Monitoring System consists of the OneTouch Ultra Plus Flex Blood Glucose Meter, OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Ultra Plus Flex 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.

The provided text describes the performance of the OneTouch Ultra Plus Flex Blood Glucose Monitoring System, particularly its accuracy against specific criteria and a reference method.

Here's an analysis based on the provided text to address your points:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is assessed in accordance with ISO 15197:2013(E) Clause 6.3 (System Accuracy) and Clause 8 (User Performance Evaluation). The acceptance criteria for blood glucose monitoring systems, as per ISO 15197:2013, dictate that for glucose concentrations <100 mg/dL, 95% of the values must fall within ±15 mg/dL of the reference measurement, and for glucose concentrations ≥100 mg/dL, 95% of the values must fall within ±15% of the reference measurement.

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

• System Accuracy (Healthcare Professionals):

  • Sample Size: 100 subjects (Page 13) resulting in 600 total meter results (200 per test strip lot across 3 lots) (Page 14).
  • Data Provenance: The study was conducted on "fingertip capillary blood samples obtained by healthcare professionals". The country of origin is not explicitly stated, but the company is based in Switzerland with a consultant in the UK, suggesting European data. The nature is prospective, as samples were "obtained by healthcare professionals" for the study.

• Lay User Performance Evaluation:

  • Sample Size: 166 lay persons (Page 15).
  • Data Provenance: "fingertip capillary blood samples obtained by 166 lay persons". Country of origin not specified, but likely similar to the professional study. The nature is prospective.

• Method Comparison Performance (initial study with healthcare professionals):

  • Sample Size: 113 subjects (Page 9) focusing on "first test sample data".
  • Data Provenance: "glucose values from the OneTouch Ultra Plus Flex Blood Glucose Monitoring System (obtained by healthcare professional fingersick samples from diabetic subjects)". Prospective data, likely similar geographical origin.

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

The ground truth was established by a laboratory reference method, the Yellow Springs Instrument (YSI) 2300 STAT PLUS glucose analyzer. This is an automated analytical instrument, not human experts. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment does not apply in this context.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth is an objective laboratory reference measurement (YSI analyzer), not human readers 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

An MRMC study was not conducted. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would typically involve human readers. The effectiveness is measured by the device's accuracy against a laboratory reference.

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

This is an inherent aspect of the device's design. The system automatically measures glucose and provides a reading. The "System Accuracy" and "Lay User Performance Evaluation" studies demonstrate the standalone performance of the device (meter and test strips) in conjunction with samples from healthcare professionals or lay users, respectively. It is an "algorithm only" performance in the sense that the device performs the measurement autonomously following sample application.

7. The Type of Ground Truth Used

The ground truth used in these studies is a recognized laboratory reference method: the Yellow Springs Instrument (YSI) 2300 STAT PLUS glucose analyzer. This is an objective, quantitative measurement, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is a traditional electrochemical blood glucose meter. Its "training" or development would involve engineering design, calibration, and extensive analytical testing (e.g., repeatability, linearity, interference) rather than machine learning on a large dataset. Therefore, a specific "training set sample size" as is common with AI/ML devices is not provided or applicable in the traditional sense. The development of the device would have involved internal validation and calibration procedures.

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

As noted above, a "training set" in the context of AI/ML is not directly applicable. The device's foundational accuracy and calibration would have been established through rigorous analytical testing during its development, likely using traceable glucose standards and established laboratory methods. The document mentions that the system was "designed and tested in accordance with ISO 15197:2013(E)." This standard outlines requirements for system accuracy, which inherently relies on comparison to a recognized reference method (like YSI).

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