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The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained for singertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or diabetes, and it is not intended for use with neonates.

The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips.

· The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use).

The Nova Biomedical StatStrip Xpress Blood Glucose Monitoring System consists of a hand held StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Blood Glucose Test Strips, StatStrip Xpress Blood Glucose Control Solutions (Levels 1, 2, 3, sold separately), and Instructions for Use Manual.

The modified StatStrip Xpress Blood Glucose Monitoring System is identical in fit, form, and functions to the StatStrip Xpress Blood Glucose Monitoring System, previously cleared in K160156. The Blood Glucose Monitor, Test Strip, and Control Solutions are identical. The only difference between the predicate and proposed device is the labeling.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: StatStrip Xpress Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

The document describes a Human Factors Study related to the device's labeling and understanding of accuracy information. The specific acceptance criteria are presented as the "predetermined acceptance criteria" for the Human Factors Study. While the exact numerical targets for each topic aren't explicitly stated as "acceptance criteria," the study's conclusion indicates that the results met these criteria. We can infer the implicit acceptance criteria from the reported "better than average" performance and the conclusion.

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

• Sample Size: 100 subjects
• Data Provenance: The document does not explicitly state the country of origin. However, given it's an FDA submission, the study was likely conducted in the United States. It is a prospective study as it involves active participation of subjects to assess understanding of new labeling.

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

This study is a Human Factors Study evaluating user understanding, not a clinical accuracy study that would typically require expert-established ground truth. The "ground truth" for this study is essentially the correct interpretation of the accuracy information as intended by the device manufacturer and regulatory guidelines. The study itself assesses the subjects' ability to understand this information. Therefore, no external experts were used to establish "ground truth" in the traditional sense of diagnostic accuracy. The study staff provided the materials and questions designed to test understanding.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of expert review for diagnostic discrepancies. This is because the study focuses on user comprehension of labeling information, not on diagnostic accuracy. Subjects answered questions, and their answers were presumably scored based on pre-defined correct responses from the study design.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tests where multiple readers interpret cases. The StatStrip Xpress Blood Glucose Monitoring System is a self-testing blood glucose meter, and this particular submission focuses on a Human Factors Study regarding labeling comprehension.

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

No, a standalone performance study (algorithm only) was not explicitly detailed in this summary. The Human Factors Study is inherently "human-in-the-loop" as it assesses how human users understand the device's labeling. While the device itself (StatStrip Xpress) has an algorithm for glucose measurement, performance data for that algorithm would typically be covered in separate analytical and clinical accuracy studies, not this Human Factors summary. This submission focuses on a modification to labeling after a previous clearance (K160156), which likely covered the algorithm's standalone performance.

7. Type of Ground Truth Used

For this Human Factors Study, the ground truth is the intended and correct understanding of the accuracy information presented on the device's labeling. The study aimed to verify that laypersons could correctly interpret this information. This is distinct from ground truth based on pathology, expert consensus, or outcomes data, which are typically used for diagnostic performance validation.

8. Sample Size for the Training Set

The document does not report a sample size for a training set. This is because the Human Factors Study described is an evaluation of understanding, not the development or training of an algorithm. If this were a machine learning algorithm, there would be a distinct training set. The subjects in this study were an evaluation group.

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

As there was no training set for an algorithm and this study is a Human Factors evaluation, the concept of establishing ground truth for a training set is not applicable here. The study assesses the "ground truth" of user comprehension against the pre-defined correct answers to comprehension questions.

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