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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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