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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 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, areonate arterial whole blood and neonate heel stick specimens.

The StatStrip Xpress Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal arterial samples throughout all hospital and all professional healthcare settings.

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 diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Xpress Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Meter operation is self-prompting using a segmented liquid crystal display (LCD) and icons. Function and data selection is accomplished using 3 push buttons. The handheld meter supports audible alerts and prompts with a built-in beeper. In addition to measuring glucose, the meter also stores up to 400 patient test records. The user can recall and review test results. A single coin battery powers the device. The StatStrip Glucose Hospital Meter Test Strips are designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood. The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action.

The provided text is a 510(k) premarket notification letter and summary for a blood glucose meter. It describes the device, its intended use, technological characteristics, and compares it to a predicate device. However, it does not contain the detailed information necessary to answer your specific questions related to acceptance criteria, test set characteristics (sample size, data provenance, expert adjudication, MRMC study, standalone performance), or training set information for an AI-based device.

The device in question, the "StatStrip Xpress Glucose Hospital Meter System," is a traditional in vitro diagnostic (IVD) device for measuring glucose, not an AI/ML-based medical device. Therefore, the concepts of "AI assistance," "human readers," "ground truth establishment using experts," "training sets," and "test sets" in the context of AI model evaluation are not applicable here.

The document discusses performance verification testing to demonstrate substantial equivalence to a predicate device, specifically noting a minor change in the lower operating temperature limit. This type of testing for IVD devices typically involves analytical performance studies (e.g., accuracy, precision, linearity, interference) rather than AI model evaluation metrics or expert ground truth adjudication.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device evaluation than what your questions presuppose (i.e., an AI/ML device approval).

To answer your questions, I would need a document that specifically details the regulatory submission and study for an AI/ML-based medical device.

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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.

The StatStrip Xpress Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings.

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 System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Meter operation is self-prompting using a segmented liquid crystal display (LCD) and icons. Function and data selection is accomplished using 3 push buttons. The handheld meter supports audible alerts and prompts with a built-in beeper. In addition to measuring glucose, the meter also stores up to 400 patient test records. The user can recall and review test results. A single coin battery powers the device, and is expected to perform up to 600 tests before needing to be replaced. A low battery prompt will appear when it is time to replace the battery. All test data is stored in a non-volatile form to prevent data loss.

The StatStrip Glucose Hospital Meter Test Strips are designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result.

The StatStrip Control Solutions are aqueous solutions that contain no products of human origin. There are three levels of control solutions (Levels 1-3). StatStrip Glucose Control Solutions are intended to verify the accuracy of the blood Glucose test results.

The StatStrip Glucose Linearity Solutions are aqueous materials with a known concentration of glucose intended to verify performance of the Nova Biomedical Analyzers. There are five levels of linearity solutions (Levels 1-5). The Linearity Solution is intended for monitoring the performance (linearity) of the StatStrip Glucose Hospital Meter System.

Here's a breakdown of the acceptance criteria and study information for the StatStrip Xpress Glucose Hospital Meter System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It specifically states: "The StatStrip Xpress Glucose Hospital Meter System that is the subject of this submission is identical in form, fit and function, to the device originally cleared in K070960." And also, "The StatStrip Glucose Hospital Meter Test Strips that are the subject of this submission are identical in form, fit, function and packaging, to the qlucose test strips originally cleared for use with the system in K070960."

Therefore, the performance testing described is likely a verification that the new model performs identically to the predicate, rather than a full de novo validation of a completely new device. This means the detailed acceptance criteria and standalone performance would have been established during the clearance of the predicate device (K132121) or the original device (K070960). The current document reports that the new device meets the same performance standards as that predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the StatStrip Xpress Glucose Hospital Meter System in this 510(k) submission. Instead, it highlights that the device is "identical in form, fit and function" to its predicate and that "The results of the performance verification testing confirmed that the StatStrip Xpress Glucose Hospital Meter System is safe and effective for its intended purpose and that the StatStrip Xpress Glucose Hospital Meter System is substantially equivalent to the predicate StatStrip Glucose Hospital Meter System (K132121)."

The comparison table (Table 2-1) emphasizes the sameness between the predicate and the modified device for key technical characteristics, implying that the performance met the same standards as the predicate.

Here's an inferred table based on the common characteristics of blood glucose meters and the affirmation of substantial equivalence:

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

The document states: "The results of the performance verification testing confirmed that the StatStrip Xpress Glucose Hospital Meter System is safe and effective for its intended purpose and that the StatStrip Xpress Glucose Hospital Meter System is substantially equivalent to the predicate StatStrip Glucose Hospital Meter System (K132121)."

However, the specific sample sizes used for the performance verification testing of the StatStrip Xpress Glucose Hospital Meter System are not detailed in this 510(k) summary. It refers to "performance verification testing" but does not provide details on the number of samples, patients, or the specific types of clinical studies (e.g., prospective, retrospective, country of origin).

Given the context of a 510(k) where the device is described as "identical in form, fit and function" to a cleared predicate, the new submission primarily validates that the manufacturing process or minor changes do not negatively impact performance, usually through bench testing and often a limited clinical bridging study. The extensive clinical performance data would have been submitted with the original (K070960) or predicate (K132121) devices.

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

This information is not provided in the document. For blood glucose meters, the "ground truth" (or reference method) is typically established by laboratory-based glucose analyzers, which are themselves highly standardized and calibrated. Expert consensus is generally not the primary method for establishing ground truth in this context.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in imaging studies where subjective expert interpretation is required. For a quantitative device like a blood glucose meter, the ground truth is established by a reference laboratory measurement, and thus adjudication methods are not applicable nor mentioned in this context.

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

No MRMC comparative effectiveness study is mentioned. MRMC studies are relevant for reader-dependent diagnostic tools, often in imaging. A blood glucose meter is a direct quantitative measurement device, not one that relies on human interpretation for its primary output.

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

For a blood glucose meter, the device itself is the "standalone" algorithm. The performance of the meter system (meter + test strip) is what is always evaluated. Therefore, yes, a standalone performance study was implicitly done as part of the "performance verification testing" where the device's measurements are compared against a reference method. The results of this testing led to the conclusion of substantial equivalence.

7. Type of Ground Truth Used

The ground truth for blood glucose measurements is almost universally established by a reference laboratory method, typically an enzymatic reference method (e.g., hexokinase method) performed on a laboratory analyzer, which is highly accurate and precise. While not explicitly stated for this specific submission's "performance verification," this is the standard for glucose meter ground truth. The document supports this by stating the device is "intended to provide plasma equivalent results to laboratory methods."

8. Sample Size for the Training Set

The document is a 510(k) submission for a device described as "identical in form, fit and function" to a predicate. This implies that the underlying algorithms and device design were already well-established and "trained" during the development of the original (K070960) and predicate (K132121) systems.

Therefore, the concept of a separate "training set" for this specific submission is not directly applicable or discussed. Any "training" would have occurred during the development phase of the prior, substantially equivalent devices, not for this specific K150461 submission, which verified performance of an identical design.

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

As mentioned above, the notion of a 'training set' for this specific submission is not relevant as it's a re-submission of an "identical" device. For the original development of such a device, the ground truth for any data used in algorithm development (if machine learning was involved, which is unlikely for a simple electrochemical biosensor calculation) would also have been established via reference laboratory methods, as described in point 7.

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The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

Nova StatStrip Glucose Test Strips are intended for use only with Nova StatStrip Glucose Hospital Meters for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatStrip Control Solutions is intended for use with Nova StatStrip Glucose Hospital Meters and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 2, and Level 3). These solutions will be offered for sale separately from the meter.

Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of Nova StatStrip Glucose Hospital Meter Systems. There are five levels of linearity solutions, (Level 2, Level 3, Level 4, and Level 5).

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any detailed study results. The document is a 510(k) premarket notification letter from the FDA, along with an "Indications for Use" statement for the Nova StatStrip Xpress Glucose Hospital Meter.

It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls provisions of the Act.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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