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The StatStrip Xpress Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.

The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.

It is not intended for use with neonate cord blood specimens.

It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, Quality Control (QC), linearity, or proficiency solutions. In addition to measuring glucose, the meter stores patient test data, and other information relating to patient sample, operator, reagents, and the meter. The meter can store up to 400 patient and/or quality control test results. The user can review all stored test results on screen. Functions and data selection are accomplished by 3 push buttons. The meter has a built-in beeper for audible alerts and prompts.

The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress Glucose Hospital Meter System.

The Nova StatStrip Glucose Control Solutions are used as a quality control check to ensure that the StatStrip Xpress Glucose Hospital Meter and the Glucose Test Strips are working properly as a system.

The Nova StatStrip Glucose Linearity Solutions are used to check the linearity of the Nova StatStrip Xpress Glucose Hospital Meter.

This is a 510(k) summary for the StatStrip Xpress Glucose Hospital Meter System. This document focuses on the claim of substantial equivalence to a predicate device and an expanded indication for use.

Here's an analysis based on your request, but it's important to note that this document is primarily a clearance letter and 510(k) summary, not a detailed study report. Therefore, much of the information regarding specific study methodologies (like sample sizes for test sets, expert details, adjudication methods, MRMC studies, or standalone performance study details) is not present in this document.

Device: StatStrip Xpress Glucose Hospital Meter System

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a table format for performance metrics. Instead, it relies on the device being "substantially equivalent" to a predicate device and having an expanded indication that was already cleared for the predicate.

The reported performance characteristics (which are the same as the predicate device) are:

Note on Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (StatStrip Glucose Hospital Meter System, K181043) and justifying that the expanded indication (for capillary whole blood specimens in all hospital and healthcare settings) was already cleared for the predicate. The document states "No changes have been made to the candidate device, the software, the test strips, controls or linearity solutions since the K161856 clearance therefore; there are no additional safety and efficacy concerns to the device." This implies that the performance data previously used to clear K161856 and K181043 are sufficient. Specific numerical acceptance criteria for accuracy (e.g., % within +/-X mg/dL) are not detailed here.

2. Sample Size for the Test Set and Data Provenance

The document does not provide details on the sample size used for a specific test set in this submission. It focuses on the fact that no changes were made to the device itself since previous clearances (K161856), and the expanded indication was already cleared for the predicate (K181043). Therefore, specific new test data for this 510(k) submission are not presented.

The data provenance is not mentioned. Typically, clinical studies for medical devices are conducted in multiple geographical locations sometimes, but this is not specified here. It's likely within the US, but not confirmed. The document does not specify if data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in this 510(k) summary. For a blood glucose meter, the "ground truth" (reference method) is usually a laboratory-based glucose analyzer, not an expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/provided in this 510(k) summary. Adjudication methods are typically relevant for subjective assessments, such as image interpretation, not for quantitative measurements like blood glucose.

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

An MRMC study is not applicable for a blood glucose meter, as it is a quantitative measurement device, not an interpretation device that benefits from human readers.

6. Standalone (Algorithm Only) Performance Study

This document describes a device (blood glucose meter and test strips) that performs a direct measurement. Its "standalone performance" is its accuracy and precision against a reference method. While the document implies this was evaluated for previous clearances, no specific standalone study details (e.g., accuracy against a lab reference method) are provided within this particular 510(k) summary. It refers to prior clearances (K150461 and K161856) for performance.

7. Type of Ground Truth Used

For blood glucose measurements, the ground truth is typically established by a laboratory reference method (e.g., a central laboratory analyzer using an enzymatic reference method). This is standard for glucose meters.

8. Sample Size for the Training Set

This information is not provided in this 510(k) summary. Given that the device relies on an electrochemical biosensor and enzyme-based measurement, rather than a complex algorithm developed through machine learning, the concept of a "training set" in the context of AI/ML is not directly applicable. The device's calibration and performance are established through manufacturing controls, quality control, and clinical validation studies (which typically would use patient samples, but these are not referred to as a "training set" for an algorithm in this context).

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

As mentioned above, the concept of a "training set" in the AI/ML sense is not directly applicable here. The ground truth for establishing the performance of such a device would be based on comparison to a highly accurate laboratory reference method for glucose measurement, which would be part of the validation for the electrochemical biosensor system. Specific details for this device are not in this document.

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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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The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. 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 screening for diabetes, and it is not intended for use with neonates.

The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions. The StatStrip Xpress Glucose Control Solutions are intended for use with the StatStrip Xpress Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results. There are 3 levels of controls (Levels 1, 2, and 3).

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

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

The StatStrip Xpress Blood Glucose Monitoring System is identical in fit, form, and function to the StatStrip Xpress Glucose Hospital Meter System which was previously cleared in K150461. The Blood Glucose Monitor, Test Strip, and Control Solutions for both the StatStrip Xpress Blood Glucose Monitoring System (subject device) and StatStrip Xpress Glucose Hospital Meter System (reference device) are identical. The only difference between them is the intended use and labeling. The StatStrip Xpress Glucose Hospital Meter System was cleared in K150461 for use with critical care patients. This submission is to expand the intended use of Nova's StatStrip Xpress Glucose Meter System to include Over-the-Counter (OTC) use for single-patient home use.

The predicate device Nova Max Blood Glucose Monitoring System (K070255) was intended for OTC/home use.

As demonstrated in Table 2-1 below, the StatStrip Xpress Blood Glucose Monitoring System has the same intended use as the Nova Max Blood Glucose Monitor System. In addition, they are the same in the following characteristics:

• The Glucose Methodology: Glucose Oxidase Biosensor
• Test results: mg/dL, plasma equivalent values
• Sampling types : capillary whole blood obtained from the fingertip
• The size and weight
• The power source
• The monitor data storage

The major difference between the subject device and the predicate device is in their test strips. The Nova Max Blood Glucose Test Strips have two measurement wells; while the StatStrip Xpress Glucose Test Strips have four measurement wells. Both test strips utilize a Reference well and a Glucose measurement well. The two additional wells designed into the StatStrip Xpress Glucose Test Strips measure and correct for Electrochemical Interferences and Hematocrit. The improved design of the StatStrip Xpress Glucose Test Strip provides increased glucose measurement accuracy even under variable electrochemical interferences and hematocrit extremes. Therefore, the test range and acceptable Hematocrit range are different between the two systems as stated in the Table 2-1.

The StatStrip Glucose Test Strip reacts with the glucose in the test sample. The reaction produces an electrical current which is proportional to the amount of glucose in the sample, and the electrical current is detected by the monitor and displayed to the user as a glucose value.

Three levels of control solutions (Level 1, Level 3) are available for use with the StatStrip Xpress Blood Glucose Monitoring System and these were previously cleared in K150461.

The Nova Biomedical Corporation's StatStrip Xpress Blood Glucose Monitoring System underwent a clinical study to demonstrate its accuracy and usability for over-the-counter (OTC) home use.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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