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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 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 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 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 diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Glucose Hospital Meter System previously cleared under K060345, K063821, and K132121 is being modified to include a new ergonomic design and wireless (Wi-Fi) connectivity option. The new system, sold under a new ordering number with wireless option, 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 ●

The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with Nova 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 onscreen keys, on-screen soft keyboard. The operator can use a finger or a PDA style stylus to select options for the on-screen 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 non-volatile form to prevent data loss.

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.

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 process provides a blood glucose result. Test strips will be sold in vials of 25 strips.

The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosityadjusting 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.

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.

The StatStrip Glucose Hospital Meter with Wi-Fi option provides an additional communication method with a healthcare facility's network system. This new Wi-Fi capability to transmit data results and other information using Radio Frequency is wholly unrelated to any of the existing technology and functionality, i.e., operations performed for the glucose measurement cycle are identical to the predicate device.

The design change of this new Wi-Fi communication method is offered on a new system as an option. i.e., the existing system without integrated Wi-Fi capability is still available. The primary difference between this new design and the cleared devices is an integrated Wi-Fi module using the IEEE 802.11 a/b/g communication protocol to transmit data.

The document provided describes a 510(k) premarket notification for a modified glucose meter, the StatStrip Glucose Hospital Meter System. The primary changes are an ergonomic redesign and the addition of Wi-Fi connectivity. The submission aims to demonstrate substantial equivalence to previously cleared versions of the device.

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the changes and the supporting evidence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format for performance metrics. Instead, it states that the bench testing and external testing "confirmed that the performance of the StatStrip Glucose Hospital Meter System with new ergonomic enhancements and Wi-Fi connectivity option is substantially equivalent to that of the StatStrip Glucose Hospital Meter System (predicate device)."

The comparative table (Table 1) focuses on technological characteristics, not performance metrics, stating the proposed device is "Same" for most entries. For the primary performance-related characteristics, such as Measuring Range, Hematocrit Range, Sample type, and Test time to result, the proposed device is declared "Same" as the predicate.

Therefore, the implicit acceptance criterion for performance appears to be demonstrating "substantial equivalence" to the predicate device for all relevant performance parameters. The reported performance is that this equivalence was confirmed by the studies.

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

The document states "Bench testing was completed" and "Additional external testing was conducted in intended use environments." However, it does not provide specific sample sizes for the test sets used in the Method Comparison Studies, Precision Studies, or Cleaning and Disinfection studies.

The document also does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the mention of "external testing... in intended use environments," it leans towards prospective testing in a clinical or laboratory setting, but this is not explicitly stated.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For glucose meters, ground truth is typically established by a reference laboratory method rather than expert interpretation of results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Since the device measures quantitative glucose levels and comparison is likely against a reference method, an adjudication process involving multiple human experts is typically not part of the ground truth establishment for such devices.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other complex data. For a glucose meter, the output is a numerical value, and the performance is assessed by comparing these values to a reference method, not by how human readers interact with an AI output.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance studies described ("Method Comparison Studies," "Precision Studies") for a glucose meter are inherently standalone algorithm performance studies. The device (meter with its embedded algorithm) generates a glucose reading, which is then compared to a reference method. There is no "human-in-the-loop" aspect to the reading process itself for a glucose meter, only for the subsequent clinical decision-making. The document confirms these types of studies were performed to demonstrate substantial equivalence.

7. The Type of Ground Truth Used

While not explicitly stated in detail, for glucose meters, the ground truth for "Method Comparison Studies" and "Precision Studies" is almost invariably established by a reference laboratory method (e.g., hexokinase method on a laboratory analyzer) known for its accuracy and precision.

8. The Sample Size for the Training Set

The document is for a 510(k) submission, which focuses on demonstrating substantial equivalence of modifications to an existing device. It discusses sensor technology and measurement algorithms being "identical" to the predicate device. Therefore, the focus is on verification and validation of the modified device, not typically on the initial development and training of a novel algorithm.

The document does not provide information about a training set size because the fundamental glucose measurement algorithm and sensor technology are stated to be the same as the predicate device. If there were any "training" in the context of the meter's internal algorithms, it would have been for the original predicate device, not for the modifications (ergonomics, Wi-Fi) described in this submission.

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

As noted in point 8, no information on a training set is provided or relevant for the modifications discussed in this 510(k). The core technology is unchanged from the predicate device.

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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 neonate heel stick specimens.
The StatStrip 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 Glucose Hospital Meter 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 self-prompting using an illuminated color 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 sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, QC preferences, and other operational settings are customizable. Data is transferred bidirectionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station.
Operator ID, patient ID, reagent lot number, test strip code, and sample accession number can be scanned into the meter using an optional built-in barcode scanner. The meter can store up to 1,000 patient test results and 200 quality control test results. The user can recall and sort or search the meter test results database to find specific test information. A rechargeable battery provides power to operate. A battery low warning will alert the user to recharge the battery. Battery charge state information is available on the "meter status screen". A System Manager selectable auto shutoff option is provided to conserve power when the meter is not in use. All test data is stored in a non-volatile form to prevent data loss.
The Test Strip is designed with an electrode that measures 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. A simple one-step process provides a blood glucose result. Test strips will be sold in vials of 50 strips.
Control Solutions are aqueous solutions that contain no products of human origin. The controls solutions are for use with the StatStrip family of meters. There are three (3) levels of control solutions (1, 2, and 3)
The StatStrip Glucose Linearity Sclutions are aqueous materials with a known concentration of glucose intended to verify performance of the Nova Biomedical Analyzers. Assay values for expected ranges are included on every bottle of linearity standards. If the results obtained are outside the expected range. the system may not be performing correctly. The combined linearity solutions are for use with the StatStrip family of meters. There are five (5) Levels of Linearity Standards.
The meter Data Docking Station is a stationary accessory used to recharge the battery in the meter. The charging station has one slot for the meter to be placed for charging and additional slots for extra batteries to be charged.
The charging station is typically located central to the patient care area being served by the meter (e.g. a nursing station). The Data Docking Station must remain plugged in to a wall outlet for power.
The Data Docking Station is used to charge the meter and can be used with a USB cable to transfer data from the meter to a central workstation (i.e. Computer Database or a Data Capture System).

The provided text describes a 510(k) premarket notification for the StatStrip Glucose Hospital Meter System. The submission is for a correction to a previous letter and primarily focuses on an expanded indication for use for an already cleared device, K063821 (Nova StatStrip Glucose Hospital Meter System). The manufacturer states that the device itself has not changed, only the labeling to allow for its use with arterial or venous samples in all hospital and professional healthcare settings.

Given this context, the acceptance criteria and supporting study described are geared towards demonstrating that the existing device performs equivalently for these expanded indications as it did for its previous indications, and equally to central laboratory methods.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy percentages within certain glucose ranges) for this particular submission. Instead, it relies on the established performance of the predicate device and demonstrates that the current device, with expanded indications, performs substantially equivalently to central laboratory methods.

The "Comparison of Predicate and Proposed device" table (Pages 6-7) highlights the characteristics that are identical between the predicate and proposed device, implying that the established performance for these characteristics remains valid.

2. Sample size used for the test set and the data provenance:

The document states: "The laboratory and clinical performance data for the StatStrip Glucose Hospital Meter System supports the expanded use of the system for arterial and venous specimens in all hospital and all professional healthcare settings." However, specific sample sizes for the test set are not provided within the given text. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.

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):

The nature of the device (a blood glucose meter) suggests that ground truth would be established through a central laboratory reference method, not by expert clinicians or radiologists. The document states "Results of clinical performance and laboratory testing demonstrate that the StatStrip Glucose Hospital Meter System produces results that are substantially equivalent to central laboratory methods." Thus, the "experts" facilitating the ground truth would be the personnel operating the central laboratory equipment, but no specific number or qualifications of these individuals are mentioned.

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

As the ground truth is established by a central laboratory reference method, adjudication by multiple experts is not applicable in this context.

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:

An MRMC study is not applicable here as this is a blood glucose meter, not an imaging device typically evaluated with human readers or AI assistance. The performance is assessed against a laboratory reference method.

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

The device itself is a standalone measurement system (the meter and test strips). Its performance is evaluated intrinsically against a reference method, so the concept of "standalone (algorithm only)" is applicable to the device itself. The clinical and laboratory performance data discussed in the document would represent this standalone performance, but without specific raw data, the exact standalone performance metrics aren't detailed beyond the statement of substantial equivalence.

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

The ground truth used for the performance studies was established by central laboratory methods for glucose determination.

8. The sample size for the training set:

The document explicitly states: "No changes have been made to the meter, the software, the test strips, the controls or the linearity solutions." This implies that the device software and algorithms were already developed and "trained" prior to this submission (likely for the predicate device K063821). The submission itself is not about developing a new algorithm or device, but extending the indication for an existing one. Therefore, no new training set information is provided or relevant to this specific submission.

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

Given that no new training set is described for this submission, this question is not applicable here. The ground truth for the original development of the predicate device's algorithms would similarly have been established by comparison to reference laboratory methods.

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The Nova StatStrip 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 the StatStrip Glucose Hospital Meter 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 the Nova StatStrip Glucose Hospital Meter 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 the Nova StatStrip Glucose Hospital Meter System. There are five levels of linearity solutions. (Level 2, Level 3. Level 4. and Level 5).

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Nova Biomedical Corp. for their Nova StatStrip Glucose Hospital Meter System. It acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. The letter primarily focuses on regulatory approval and indications for use.

Crucially, this document does not contain the detailed acceptance criteria for device performance, nor does it describe specific studies proving that the device meets such criteria. It lists the "Indications for Use" for the device, but these are about how the device is intended to be used, not its performance metrics like accuracy, precision, or detection limits.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance), or ground truth establishment based solely on the text provided. This information would typically be found in the actual 510(k) submission document itself (which is not provided), or in a separate study report or technical documentation for the device.

Ask a specific question about this device

The Nova StatStrip Glucose Hospital Meter 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 and arterial 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 the StatStrip Glucose Hospital Meter 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 the Nova StatStrip Glucose Hospital Meter 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 1, 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 the Nova StatStrip Glucose Hospital Meter System.

Not Found

This is a 510(k) premarket notification for a glucose meter and does not contain the detailed study information typically found in a clinical trial report or a scientific publication describing device performance and acceptance criteria. The provided document is an FDA clearance letter and an Indications for Use statement.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study that proves the device meets specific criteria based solely on the provided text. The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than proof of meeting specific, pre-defined acceptance criteria in a detailed study report within this document.

For a glucose meter, acceptance criteria typically relate to accuracy (e.g., bias, precision, and agreement with a reference method as per ISO 15197 for point-of-care blood glucose monitoring systems) and other performance characteristics, but these specific criteria and the data to prove them are not in this clearance letter.

To answer your specific questions in the format requested, based only on the provided text, I can state:

1. Table of acceptance criteria and the reported device performance:
   Not provided in this document. The document primarily concerns the FDA's substantial equivalence determination, not a detailed presentation of performance data against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   Not provided in this document.

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 or not provided. For a glucose meter, ground truth is typically established by laboratory reference methods (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer), not expert readers.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable or not provided.

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 a glucose meter, not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
   A glucose meter inherently operates "standalone" in generating a quantitative reading. However, the details of its standalone performance testing (e.g., accuracy against a reference method) are not included in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   While not explicitly stated in this document, for glucose meters, the ground truth is typically established using a high-precision laboratory reference method (e.g., hexokinase method on a central laboratory analyzer).

8. The sample size for the training set:
   Not applicable or not provided. This device is likely using established electrochemical principles; modern machine learning "training sets" are not typically used for this type of device in the same way they would be for an AI algorithm.

9. How the ground truth for the training set was established:
   Not applicable or not provided.

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