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For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TRUEresult ™ and TRUE2go™ Meters and TRUEtest™ Test Strips.

The AbT Glucose Control Solutions consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-hazardous and contains no human or animal derived materials.

This document, K091460, is a 510(k) Premarket Notification for the AbT Glucose Control Solutions. It aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for each performance characteristic. Instead, it implies acceptance by the successful completion of the studies and the comparison to the predicate device's characteristics. The performance study details are limited to the types of studies performed without specific quantitative results.

However, based on the Comparison to Predicate Devices section, we can infer some target ranges for glucose levels, which could be considered an implicit acceptance criteria tied to the predicate's performance.

Important Note: The document states for the predicate's Target Range "(1) Estimated from the manufacturer's published control ranges." This means the predicate's ranges are not direct measurements from this submission but publicly available information used for comparison. The new product also provides specific target ranges, which are the intended performance of the device.

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

The document does not provide any specific sample sizes for the performance studies (Accelerated Stability, Open Vial, Test Precision).

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "Tests were performed to verify specific performance characteristics."

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

This information is not provided in the document. The type of device (glucose control solutions, which are laboratory reagents) typically involves analytical testing rather than interpretation by human experts to establish ground truth for performance.

4. Adjudication Method for the Test Set:

This information is not provided and is generally not applicable for this type of device where objective analytical measurements are performed rather than subjective assessments.

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 imaging devices or algorithms that require human interpretation, not for glucose control solutions which are used to verify the performance of a measuring instrument.

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

This question is not applicable as the device is a chemical control solution, not an algorithm or a device with an AI component. The "performance" being evaluated is the stability and precision of the chemical solution itself, and its ability to elicit expected readings on the specified meters.

7. The Type of Ground Truth Used:

For the AbT Glucose Control Solutions, the ground truth is established by analytical measurement of the glucose concentration in manufactured lots of the control solutions. The "known quantities of glucose" in the solution form the basis of the ground truth. This is implied by the product description "containing known quantities of glucose." The stability and precision studies then assess how well the device maintains these known quantities over time and delivers consistent results when tested.

8. The Sample Size for the Training Set:

This information is not applicable as the AbT Glucose Control Solutions are not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this device.

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For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Agamatrix WaveSense Presto Blood Glucose Monitor.

The AbT Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. It is packaged in a plastic dropper tipped bottle for easy application of the control solution to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.

The AbT Glucose Control Solution is a control material for blood glucose monitoring systems. The provided documentation does not detail a study involving human readers or comparative effectiveness for diagnostic image analysis. Instead, it describes a device for quality control in glucose measurement. The performance studies focused on the stability and precision of the control solution itself, not on diagnostic accuracy in the way an AI-powered image analysis tool would be evaluated.

Here's an analysis based on the provided text, reformatted to address your specific questions about acceptance criteria and study details, albeit adapted for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For the AbT Glucose Control Solution, the "acceptance criteria" are defined by its target glucose range and its ability to maintain stability and precision within that range. The "reported device performance" reflects how these characteristics compare to predicate devices.

Note: The specific quantitative results for stability and precision are not provided in this summary but are indicated as having been performed and concluded to be satisfactory.

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

The document does not specify a "test set" in the context of diagnostic performance on patient data since this device is a quality control solution.

• Sample Size: Not applicable in the traditional sense of patient data. The "samples" would be aliquots of the control solution itself. The document does not provide the number of replicates or batches tested for stability and precision studies.
• Data Provenance: Not applicable in the context of patient data. The studies would have been conducted internally by American Biological Technologies, Inc. No country of origin for patient data is relevant here. The studies are prospective in nature, testing the manufactured control solution.

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

Not applicable. "Ground truth" for a control solution relates to its manufactured glucose concentration and its stability and precision characteristics, not diagnostic interpretations by experts. The "ground truth" would be established through analytical chemistry methods during production and quality control testing.

4. Adjudication Method

Not applicable. Adjudication methods are relevant for expert review of diagnostic cases, which is not the purpose of this device.

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

Not applicable. This device is a quality control solution, not a diagnostic tool intended for interpretation by human readers. Therefore, an MRMC study is not relevant.

6. Standalone Performance

Yes, in a sense. The "performance studies" (stability, open vial stability, test precision) are evaluations of the AbT Glucose Control Solution itself and its inherent characteristics. This is a form of standalone performance assessment, focusing on the quality and reliability of the control solution as a product. The results of these studies informed the claim of substantial equivalence to predicate devices.

7. Type of Ground Truth Used

The "ground truth" for the AbT Glucose Control Solution is based on analytical manufacturing specifications and laboratory testing.

• Glucose Concentration: The target range (95 - 145) is a defined analytical specification for the product.
• Stability: This is determined by monitoring the glucose concentration over time under various storage conditions.
• Precision: This is determined by repeatedly measuring the glucose concentration and analyzing the variability.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set" of data. Its "performance" is based on its physical and chemical properties as a control solution.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish in this context.

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For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Contour TS Blood Glucose Monitor.

The AbT Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.

The AbT Glucose Control Solution is a quality control material intended for in vitro diagnostic use to assess the performance of the Contour TS Blood Glucose Monitor. The 510(k) summary provides a comparison to predicate devices and outlines performance studies conducted to support the claim of substantial equivalence.

Here's an analysis of the provided information against your requested criteria:

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

The document provides a comparison to predicate devices and lists "Target Range (mg/dL)" under the "Comparison to Predicate Devices" table, which can be interpreted as an acceptance criterion for the control solution's glucose level. The reported performance is the established target range for the new device.

Note: The document also mentions "performance characteristics" like "Accelerated Stability," "Open Vial," and "Test precision" were verified, but it does not provide specific numerical acceptance criteria or reported performance values for these studies. It only states that tests were performed to verify these characteristics and that the "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence."

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

The document does not explicitly state the sample size used for any of the performance studies (Accelerated Stability, Open Vial, Test Precision).
The document does not provide information on the country of origin or whether the data was retrospective or prospective.

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)

This device is a glucose control solution, not an AI or diagnostic imaging device that requires expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth" as you've framed it (e.g., radiologists) is not applicable here. The ground truth for the control solution's glucose concentration would be established through laboratory analytical methods, not subjective expert assessment. The document does not provide details on the specific analytical methods or individuals who established the true glucose concentration.

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

Not applicable for a glucose control solution. Ground truth for a control solution's glucose concentration is determined by analytical measurements, not expert adjudication.

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 glucose control solution, not an AI-assisted diagnostic tool for human readers.

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

This refers to an algorithm's performance without human interaction. This is not applicable as the device is a control solution, not an algorithm. The control solution itself doesn't have an "algorithm" in the typical sense; its performance is based on its chemical properties and stability.

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

For a glucose control solution, the "ground truth" for the glucose concentration would be established through analytical laboratory methods (e.g., reference methods for glucose measurement). The document does not explicitly state the specific methods used to establish the ground truth for the control solution's glucose concentration.

8. The sample size for the training set

Not applicable. This device is a manufacturing product (a control solution), not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the FreeStyle and FreeStyle Lite Blood Glucose Monitors.

The AbT Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.

Here's a breakdown of the acceptance criteria and the study information for the KCJ3549 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The document states: "Performance Studies: Tests were performed to verify specific performance characteristics: 1. Stability 2. Open Vial 3. Mean and Variance Comparison."

The conclusion is: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence."

This indicates that the AbT Glucose Control Solution was subjected to these performance studies, and the results demonstrated that it met the necessary criteria, leading to the determination of substantial equivalence to the predicate devices. The acceptance criteria themselves are primarily defined by the characteristics of the predicate devices (e.g., target range, fill volume, matrix, intended use) to which the new device is compared. The specific acceptance thresholds for "Stability," "Open Vial," and "Mean and Variance Comparison" are not detailed in this summary but are implicit in the performance verification.

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

The provided 510(k) summary does not specify the sample size used for the test set in the performance studies (Stability, Open Vial, Mean and Variance Comparison).

The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

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 device is a "Quality Control Material," and its "ground truth" would typically refer to the measured glucose concentration within the control solution itself, established through analytical methods rather than expert consensus on diagnostic images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, such as evaluating medical images. For a glucose control solution, the performance is assessed through quantitative measurements against established standards.

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

There was no MRMC comparative effectiveness study done. This type of study involves human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on human performance. The device in question, an AbT Glucose Control Solution, is a quality control material and not an AI-powered diagnostic device that assists human readers.

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

This question is not applicable as the device is a chemical control solution, not an algorithm or AI system.

7. The Type of Ground Truth Used

For a glucose control solution, the "ground truth" is the known, assayed concentration of glucose within the solution itself. This would be established through laboratory analytical methods (e.g., reference methods for glucose measurement). The document implicitly refers to this "target" glucose level (88 mg/dL) and "target range" (80-130 mg/dL).

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a manufacturing product (a glucose control solution), not an AI algorithm that requires a training set. The "formulation" is the key aspect, not a statistical training set.

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

This information is not applicable/provided for the reasons stated in point 8.

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