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The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories.

The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip.

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

The system is not intended for use on patients receiving intensive medical intervention/therapy.

The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.

The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter, the XPER Technology PREMIUM Pro Blood Glucose Test Strips, and the TaiDoc Blood Glucose Control Solutions. This system is a multiplepatient use for the quantitative determination of glucose in capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories as an aid in monitoring the effectiveness of glucose control. The TaiDoc Blood Glucose Control Solutions are used to check that the meter and test strips are working together properly.

Here's a breakdown of the acceptance criteria and study details for the XPER Technology PREMIUM Pro Blood Glucose Monitoring System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the statement "all test results were within acceptance criteria" in various sections. The reported performance is the achievement of these criteria. The specific numerical targets for each criterion are not always explicitly stated (e.g., for precision, linearity, hematocrit, interference), but the document confirms that the device met these criteria.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This document describes a medical device, a Blood Glucose Monitoring System, which does not utilize AI or involve human readers for image interpretation. Therefore, questions related to AI models, human reader improvement with AI assistance, expert adjudication for ground truth related to image analysis, or MRMC studies are not applicable to this device.

Here's the relevant information based on the provided text:

1. Sample sizes used for the test set and data provenance:

   • Clinical Accuracy (Capillary Blood): 414 patients.
     • Provenance: Clinical study conducted at 3 U.S. sites and 6 Taiwan sites. Data is prospective as it was collected during an active clinical study with patients.
   • Accuracy at Extremes: 100 samples (50 for 300 mg/dL).
     • Provenance: "Blood samples were collected and allowed to glycolyze or were spiked with high concentration glucose solution". Implies a laboratory-controlled, prospective or specially prepared sample set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable in the traditional sense of 'experts' interpreting data. For blood glucose monitoring systems, the "ground truth" is established by a highly accurate reference method.
   • The ground truth for the clinical and extreme glucose value studies was the YSI Model 2300 Glucose Analyzer. This is a laboratory-based, well-established, and highly accurate reference method for glucose measurement, not human experts.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. As ground truth is established by an automated reference analyzer (YSI-2300), there is no human interpretation or adjudication process involved in setting the ground truth for glucose values.

4. 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:

   • Not Applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. There are no human readers or AI assistance in the interpretation of results from this device in the same way as an imaging study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. Blood glucose meters are inherently "standalone" in their function of measuring glucose. The clinical study directly compares the device's numerical output (algorithm's result) to the YSI-2300 reference method without human interpretation of the device's output influencing the direct comparison. The "human-in-the-loop" for this device is the user taking and reading the measurement, but the performance evaluation is on the accuracy of the numerical reading itself, independent of user interpretation for the primary outcome.

6. The type of ground truth used:

   • Reference Method: The YSI Model 2300 Glucose Analyzer, a laboratory-based, highly accurate method for quantitative glucose determination. Comparisons are quantitative.

7. The sample size for the training set:

   • Not directly applicable/not explicitly stated in terms of an "AI training set." This device is a traditional electrochemical biosensor, not an AI/machine learning model that undergoes a distinct "training" phase with a large dataset in the way a deep learning algorithm would. The development and calibration of such a device involve extensive laboratory testing and optimization, which could be considered an analogous "training" or development process for its internal algorithms, but it's not described as a separate, quantifiable "training set" with ground truth in the context of AI regulatory submissions.

8. How the ground truth for the training set was established:

   • Not applicable in the AI context. For this type of device, ground truth for development/calibration (analogous to "training") would be established through a combination of:
     • Highly controlled laboratory experiments using reference solutions of known glucose concentrations.
     • Comparisons to established reference methods (like YSI-2300) with well-characterized samples.
     • Controlled studies to characterize and mitigate interferences (e.g., hematocrit, medications).

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The StatStrip 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 neonatal 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 neonatal 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 Glucose Hospital Meter System includes the following components:

• StatStrip Glucose Hospital Meter
• StatStrip Glucose Test Strips

StatStrip Glucose Hospital Meter System:
The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated color touch-screen Graphical User Interface (GUI).

StatStrip Glucose Test Strips:
The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. 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 provides a blood glucose result. Test strips will be sold in vials of 25 strips.

StatStrip Glucose Control Solutions:
The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.

StatStrip Glucose Linearity Solutions:
There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.

Charging (Docking) Station:
The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power.

The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.

Here's a breakdown of the acceptance criteria and study details for the StatStrip Glucose Hospital Meter System (K232075), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the FDA Guidance for POC Device Acceptance Criteria (Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, September 29, 2020). The performance of both the proposed and predicate devices is reported against these criteria.

| Acceptance Criteria (FDA Guidance) | Proposed Device Performance (

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The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing facilities, for multiple patient use. This system should only be use, auto-disabling lancing devices for drawing finger stick capillary blood.

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

The system is not intended for use in acute care or hospital settings.

The system is not intended for neonatal use.

The system is for prescription use only.

The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered meter, disposable test strips Assure Titanium Blood Glucose Test Strips, and control solutions. The Assure Titanium Blood Glucose Test Strips utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current (amperometry). The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the patient's glucose level.

The Assure® Titanium Blood Glucose Monitoring System underwent extensive performance testing to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision (Within-run): 1500 tests (500 results on each of 3 lots)

• Precision (Intermediate): 1500 tests (50 tests per lot per day over 10 days for 3 lots)

• Linearity: 165 results (5 replicates per level for 11 glucose concentrations, across 3 test strip lots)

• Clinical Accuracy (Method Comparison): Capillary blood samples from 396 patients were measured.

  • Site #1 (Nursing/Skilled Nursing Facility): 130 patients
  • Site #2 (Endocrinology Clinic, California): 165 patients
  • Site #3 (Endocrinology Clinic, Georgia): 101 patients

• Accuracy at Extremes: 100 samples (50 samples 300 mg/dL).

  The provenance for precision, linearity, hematocrit, and interference studies appears to be laboratory-controlled (venous whole blood spiked or glycolyzed). The clinical study data provenance is prospective, collected in the United States (Massachusetts, California, Georgia) at one nursing/skilled nursing facility and two endocrinology clinics.

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

The document mentions that the YSI Model 2300 Glucose Analyzer was used as the reference standard (comparator method) for establishing ground truth in the linearity, clinical accuracy, and accuracy at extremes studies. The YSI 2300 is a laboratory instrument, not a human expert. Therefore, no human experts were used to establish the ground truth for these quantitative measurements.

For the usability study, "POC operators" were involved in evaluating the system, but they weren't establishing a "ground truth" for glucose levels. Their qualifications are not specified beyond being "Point-of-Care operators."

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth for glucose measurements was established by a laboratory reference instrument (YSI 2300), not through expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a Blood Glucose Monitoring System, and its performance is evaluated by comparing its readings directly to a laboratory reference standard (YSI 2300), not by assessing how human readers improve with AI assistance.

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

Yes, the core performance studies (precision, linearity, hematocrit, interference, environmental, altitude, error codes, short sample detection, sample perturbation, used test strip detection) evaluate the standalone performance of the Assure® Titanium Blood Glucose Monitoring System (meter and test strips) by comparing its output directly to a reference method or evaluating built-in error detection mechanisms.

The clinical accuracy study also compares the device's measurements (obtained by POC operators, but the measurement itself is algorithmic) against the YSI 2300 reference, effectively demonstrating its standalone accuracy in a clinical setting.

7. The Type of Ground Truth Used:

The primary ground truth used for quantitative glucose measurements was reference laboratory method data, specifically from the YSI Model 2300 Glucose Analyzer.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its size. This is typical for a medical device cleared via a 510(k) pathway, especially for a blood glucose monitoring system, where development often involves calibration and verification/validation against reference methods rather than supervised machine learning model training.

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

Not applicable, as a separate training set and its ground truth establishment are not discussed in the provided submission. The device's underlying principles (electrochemical biosensor) are well-established, and its "training" or calibration would typically be an inherent part of its manufacturing process, verified through performance testing against reference standards as described.

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The StatStrip Xpress 2 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 healtheare 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 diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Xpress 2 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, a Quality Control (QC) solution, 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 2 Glucose Hospital Meter System.

The Nova StatStrip Glucose Control Solutions are used as a quality control check to ensure that the StatStrip Xpress 2 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 2 Glucose Hospital Meter.

The provided text describes a 510(k) premarket notification for the StatStrip Xpress 2 Glucose Hospital Meter System. It states that the purpose of this submission is to change the labeling to include the use of capillary whole blood specimens in all hospital and professional healthcare settings, including for patients receiving intensive medical intervention/therapy. Crucially, it highlights that this expanded indication was previously cleared for the predicate device, StatStrip Glucose Hospital Meter System (K181043), and no changes have been made to the candidate device itself, the test strips, controls, or linearity solutions since its prior clearance (K163490).

Therefore, the submission is not focused on proving the device meets new acceptance criteria through a new study, but rather on demonstrating substantial equivalence to a predicate device that already had this expanded indication cleared. The document implies that the device inherently meets these criteria because it is identical to a previously cleared device for the expanded use.

Given this context, if we were to infer "acceptance criteria" and "study" from the provided text, it would be based on the original clearance of the predicate device (K181043) for the expanded indication, or the original clearance of the candidate device (K163490) for its initial indications. However, the current document does not detail those studies.

Therefore, many of the requested items (sample size, data provenance, expert ad-judgement, MRMC studies, standalone performance, training set details) are not described in the provided text because this 510(k) relies on the substantial equivalence principle, not on a new study for the device itself to prove the expanded indication.

Here's a breakdown of what can be inferred or directly stated from the text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or performance data from a new study specific to this K182549 submission. It states: "The expanded indication proposed in this submission was previously cleared for the predicate device (K181043). No changes have been made to the candidate device, the software, the test strips, controls or linearity solutions since the K163490 clearance therefore; there are no additional safety and efficacy concerns to the device." This implies that the performance data for this expanded indication was deemed acceptable in the predicate device's clearance.

However, the "Comparison of Predicate and Candidate devices" table (Page 5-6) lists technological characteristics that could act as implied performance specifications or features if a study were to be conducted. Since no new study is described, this is a comparison of design, not performance data from a new study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified. The document does not describe a new study or test set for this 510(k) submission. It relies on the previous clearance of the predicate device for the expanded indication.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. Since no new human-expert based ground truth for a test set is described, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. No new test set or adjudication process is described.

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

• Not applicable. This device is a blood glucose meter, not an AI imaging analysis system that assists human readers.

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

• Yes, implicitly. A blood glucose meter operates as a standalone device, providing a quantitative result without human "interpretation" of a complex output. The "performance" of such a device is typically assessed as an algorithm (meter software) reading a biochemically induced electrical signal. However, the document does not describe the specific standalone performance study from this submission, but rather refers to prior clearances.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For a blood glucose meter, the ground truth would typically be established by a reference method (e.g., a laboratory-grade glucose analyzer, often using enzymatic or hexokinase methods) that is highly accurate and precise. This is implied by the nature of glucose measurement, but not explicitly stated in this document for this submission.

8. The sample size for the training set

• Not specified. No details on training sets are provided, as this is not a de novo AI/ML device submission. The device is based on established electrochemical biosensor technology.

9. How the ground truth for the training set was established

• Not specified. (See point 8).

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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 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, 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 diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Glucose Hospital Meter System was previously cleared under K150281. The purpose of this dual 510(k) and CLIA Waiver submission for the StatStrip Glucose Hospital Meter System is to expand the indication for use to include the use of capillary specimens on patients receiving intensive medical intervention/therapy and support a CLA Waived categorization for this expanded indication for use to include the quantitative determination of glucose in capillary finger stick throughout all hospital and all professional healthcare settings. No changes have been made to the software, the test strips, controls or linearity solutions.

The system contains the following:

• 1. StatStrip Meter, with integrated Wi-Fi connection and antenna option
• 2. Charging Station
• 3. Vial of StatStrip Test Strips
• 4. Battery (3.7 V Lithium)
• 5. Quick Reference Guide
• 6. Instructions for Use Manual
• 7. StatStrip Log Book

Offered separately:

• . StatStrip Test Strips
• Quality Control Solutions, Level 1, 2, 3
• Linearity Solutions, Levels 1, 2, 3, 4, 5.

Meter: The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with Nova StatStrip Glucose test strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated touch-screen Graphical User Interface (GUI). In addition to measuring glucose, the meter also stores patient test data, quality control test data and other information relating to the patient, patient sample, operator, reagents and meter.

The self-prompting menu system is navigated by means of a combination of touch-panel on-screen keys, on-screen soft keyboard. The operator can use a finger or a PDA stylus to select options for the onscreen display. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. The Meter also has a barcode scanner that automates data entry.

The rechargeable batteries provide sufficient power to operate for 8 hours before requiring recharging. A "battery fuel gauge" bitmap constantly informs the user as to the current state of charge on the battery. Battery charge state information is available on the "meter Welcome screen". The meter will shutoff (Sleep) after 90 seconds of inactivity. Test data and meter setup information will be stored in a nonvolatile form to prevent data loss.

Charging (Docking) Station: The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed for charging and a slot for an extra battery to be charged.

The charging station should be located central to the patient care area being served by the meter (e.g. a nursing station). The data charging station must remain plugged in to a wall outlet for power.

The system still allows the charging station to be used to transfer data from the meter to a central workstation, and allow meter setup information to be downloaded from the central workstation to the meter.

Test Strips: The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricvanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. 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. Test strips will be sold in vials of 25 strips.

Control Solutions: The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.

Linearity Solutions: There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.

Replacement batteries will be offered separately.

Wi-Fi Option: The StatStrip Glucose Hospital Meter provides a Wi-Fi communication method with a healthcare facility's network system. The wireless radio chipset utilizing the IEEE 802.11 alb/g communication protocols (Wi-Fi) is used as an optional means to transmit and receive test results, previously cleared under K150281.

The provided text describes the Nova Biomedical Corporation's StatStrip Glucose Hospital Meter System. Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Device Performance for StatStrip Glucose Hospital Meter System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for glucose meters, particularly those for critical care, typically align with ISO 15197 standards or internal company-defined standards that demonstrate clinical agreement. While explicit "acceptance criteria" are not given in quantitative terms like "must achieve X% within Y mg/dL," the clinical study performance data serves as the reported performance against FDA's substantial equivalence requirements. Therefore, the "acceptance criteria" can be inferred from the performance metrics demonstrated.

Interpreted Acceptance Criteria (Based on Study Performance):

• **For glucose concentrations =75 mg/dL). This suggests that after filtering or specific data points, these are the totals used for analysis.
  • Data Provenance: Retrospective data mining ("real world evidence") from two leading medical centers in the U.S. (one in Minnesota and one in Maryland). These were described as CLIA Waived retrospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The ground truth was established by a central laboratory comparator method.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

This is not applicable. The device is a glucose meter, not an imaging device or AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, the studies assessed the performance of the StatStrip Glucose Hospital Meter System (algorithm-driven device) by comparing its readings to a central laboratory comparator method. This is essentially a standalone performance evaluation of the device itself. The "CLIA Waived operators" used the device, but the performance being measured is of the device's accuracy compared to a gold standard, not the operator's diagnostic ability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth was established using plasma glucose specimens obtained from either an arterial or venous specimen as measured on a central laboratory comparator method, specifically an IDMS traceable hexokinase comparator method (Roche Cobas System, Roche Diagnostics, Indianapolis, IN). This is considered a highly accurate and standardized laboratory method for glucose determination.

8. The sample size for the training set:

This information is not provided in the document. The document describes clinical studies for performance evaluation for a 510(k) submission, not specifically developmental or training data for the device's underlying technology. The device itself was previously cleared (K150281) and this submission is an expansion of its indication for use, implying the core technology was already developed and validated.

9. How the ground truth for the training set was established:

This information is not provided in the document, as the document focuses on the expanded indication's validation rather than the initial device development.

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The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnosic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, neonate arterial whole blood and neonate heel stick specimens.

The StatStrip Xpress 2 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 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 Nova Biomedical StatStrip Xpress 2 Glucose Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The test strip contains a reagent (glucose oxidase) that reacts with the glucose in the test sample is applied to the test strip, which is then analyzed in the meter. The reagent test strip contains glucose oxidase and glucose dehydrogenase, which reacts with the glucose in the test sample.

A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. When enough sample has been added to the strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 6 seconds. The system is designed for hospital point of care (POC) use including physicians' office labs.

The provided document discusses the StatStrip Xpress 2 Glucose Hospital Meter System, a point-of-care, in vitro diagnostic device for quantitative determination of glucose. The document is a 510(k) summary and indicates that the proposed device is substantially equivalent to a predicate device (K152986). The only change mentioned is the modification of the lower limit of the operating temperature range from 15°C to 5°C.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., accuracy percentages, bias limits) for the glucose meter's performance. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "Reported Device Performance" is implicitly that the device performs equivalently to the predicate device across all characteristics, with the exception of the broadened operating temperature range, which is stated not to adversely affect safety or efficacy.

The document provides a comparison table (Table 1) between the predicate and proposed devices, which details various characteristics:

The document states, "The modification of the lower limit of the operating temperature range from 15°C to 5°C does not adversely affect the safety or efficacy of the device." This statement implies that testing was conducted to prove the device's performance remains acceptable within this extended temperature range, but the specific data or acceptance criteria used for this proof are not detailed in the provided text.

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

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies supporting the device's performance.

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

This information is not available in the provided document. The document pertains to a medical device (glucose meter) rather than an AI or image-based diagnostic system that would typically require expert ground truth labeling.

4. Adjudication Method for the Test Set

This information is not available in the provided document. As mentioned above, this is not typically applicable for a glucose meter's performance evaluation in the same way it would be for an AI diagnostic.

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

This information is not applicable to the StatStrip Xpress 2 Glucose Hospital Meter System, as it is a standalone diagnostic device and not an AI-assisted interpretation tool for human readers.

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

The device itself, the StatStrip Xpress 2 Glucose Hospital Meter System, operates in a standalone manner to provide glucose measurements. The 510(k) summary implicitly covers the standalone performance of the device without human interpretation of the underlying signal, as it provides a direct digital readout. However, this is distinct from "algorithm only performance" in the context of an AI-driven system that outputs a diagnostic result for human review.

7. The Type of Ground Truth Used

For a glucose meter, the "ground truth" for accuracy studies would typically be established by comparing the device's readings to a laboratory reference method (e.g., a central lab analyzer using a hexokinase or glucose oxidase method) known for its high accuracy and precision. The document does not explicitly state the type of ground truth used, but this is the standard practice for such devices. It's not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

This information is not available in the provided document. As a traditional medical device (not an AI/machine learning product for which a "training set" is typically discussed), the concept of a training set for an algorithm as a distinct entity is not explicitly mentioned. Development and validation would involve various studies, but not in the framework of training an AI model.

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

This information is not available in the provided document. See the explanation for point 8.

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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 2 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 2 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 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.

lt 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 previously cleared under K070960 and K150461 is being modified to include a 2.2 inch color graphics display and an updated ergonomic design. The new system will be sold as the StatStrip Xpress 2 Glucose Hospital Meter System.

The intended use of the modified StatStrip Xpress 2 Glucose Hospital Meter System has not changed as a result of the modifications.

The StatStrip Xpress 2 Glucose Hospital Meter utilizes a 2.2" color graphics display in place of the segmented display that is currently used in the predicate StatStrip Xpress Glucose Hospital Meter. The color screen allows for the user interface to be displayed in a more modern format; however the overall screen content of the meter will remain unchanged from the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter will utilize the same screen progressions and user workflow as the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same three button keypad design as the predicate to navigate the user interface.

To support the increased power requirements of the color display, the newly designed StatStrip Xpress 2 Glucose Hospital Meter will be powered by two AAA batteries in place of the single Li 2450 coin cell battery used in the predicate StatStrip Xpress Glucose Hospital Meter.

The StatStrip Xpress 2 Glucose Hospital Meter uses identical signal processing and results generating methods and stores test results in the same manner as the predicate device.

The StatStrip Xpress 2 Glucose Hospital Meter's new ergonomic design introduces a flat, top surface design that eliminates ridges, recessed corners and raised edges. The strip port has been moved to the bottom of StatStrip Xpress 2 Glucose Hospital Meter in order to increase customer satisfaction. The new location of the strip port reduces the chance of control material entering the strip port. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same strip port and electronics for making glucose measurements as the predicate device. The proposed device has the same performance characteristics as the predicate device.

The provided text describes modifications to an existing device, the StatStrip Xpress Glucose Hospital Meter System, to create the StatStrip Xpress 2 Glucose Hospital Meter System. The primary changes are an updated 2.2-inch color graphics display, an updated ergonomic design, and a change in battery type. The document explicitly states that the intended use, sensor technology, measurement electronics, measurement algorithms, test strip formulations, product manufacturing, and quality control remain the same as the predicate device. Therefore, the performance characteristics are expected to be identical to the predicate device.

Given that the current submission is for modifications to an already cleared device and not a de novo submission for a new device, the document does not contain new studies to establish acceptance criteria or device performance for the StatStrip Xpress 2 beyond what was previously established for its predicate. It relies on the substantial equivalence to the previously cleared device (K070960 and K150461).

As such, I cannot provide a table of acceptance criteria and reported device performance, nor details on new studies, as these were not conducted for this specific submission. The document's focus is on demonstrating that the modifications do not introduce new concerns for safety and effectiveness and that the new device maintains the performance characteristics of its predicate.

To answer your request, I will extract relevant information about the predicate device's characteristics as implied by the substantial equivalence claim.

Here's a breakdown based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a new table of acceptance criteria and reported device performance for the StatStrip Xpress 2 Glucose Hospital Meter System. It asserts that the proposed device has the same performance characteristics as the predicate device (StatStrip Xpress Glucose Hospital Meter System, K150461 and K070960), due to identical sensor technology, measurement electronics, measurement algorithms, and test strip/control/linearity solution formulations.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission. The claim is based on the previously established performance of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission.

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

Not applicable. This is an in vitro diagnostic device for glucose measurement, not an AI-assisted diagnostic imaging device for human readers.

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

The device is a standalone glucose meter. Its performance is evaluated intrinsically against laboratory reference methods. The document states: "It is intended to provide plasma equivalent results to laboratory methods." This implies that the standalone performance was established during the clearance of the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the predicate device, the implied ground truth for glucose measurement is a laboratory reference method. The statement "It is intended to provide plasma equivalent results to laboratory methods" supports this.

8. The sample size for the training set

Not applicable. This device relies on established electrochemical principles, not machine learning or AI models with training sets.

9. How the ground truth for the training set was established

Not applicable, as no training set (in the machine learning sense) is mentioned.

Summary based on the provided document:

The FDA 510(k) submission for the StatStrip Xpress 2 Glucose Hospital Meter System did not require new studies to prove acceptance criteria because the device is a modified version of a previously cleared predicate device. The core measurement technology, algorithms, and intended use remain unchanged. Therefore, the performance characteristics of the StatStrip Xpress 2 are considered substantially equivalent to its predicate. The document implicitly relies on the studies and performance data submitted for the clearance of the predicate devices (K070960 and K150461) to demonstrate the StatStrip Xpress 2's effectiveness and safety.

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