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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 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 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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