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The GLUCOMETER ELITE Blood Glucose Test Systems are used for self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.

The GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter (OTC) home testing systems for glucose in blood. These systems are for use by person with diabetes and by healthcare professionals in a home setting and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter home tests for glucose in blood. They are for use by persons with diabetes and by healthcare professional in home settings and in healthcare facilities. The GLUCOMETER ELITE Blood Glucose Test Strips are for use with the GLUCOMETER ELITE Blood Glucose Test family of meters.

The GLUCOMETER ELITE and the GLUCOMETER ELITE XL Blood Glucose Meters are specific for glucose and have been referenced to give plasmalserum equivalent glucose results. The test systems provide a quantitative measurement of glucose in whole blood from 10 - 600 mg/dL (0.6 to 33.3 mmol/L). In addition, both the GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER XL Blood Glucose Meter can be used with arterial blood specimens. The GLUCOMETER XL Blood Glucose Meter can be used with neonatal specimens.

The GLUCOMETER ELITE Blood Glucose Test Strips are based on the measurement of electrical potential caused by the reaction of glucose with the reagents (Glucose Oxidase method) on the electrode of the strip.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Glucometer® Elite® Blood Glucose Test Systems:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria (e.g., "accuracy should be within +/- X% of reference method Y"). Instead, it focuses on demonstrating suitability for expanded use cases.

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

The text states that evaluations were "conducted at four clinical sites" and a "separate clinical study was conducted." However, it does not provide specific sample sizes for the test set(s) or the country of origin of the data. Given the "Conclusion" statement and the nature of medical device submissions, it is highly likely that these were prospective studies since they were conducted to demonstrate performance for expanded indications.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. For a blood glucose meter, ground truth is typically established using a highly accurate laboratory reference method, not necessarily by expert consensus in a subjective sense.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set. This is not typically relevant for quantitative measurements like blood glucose, where a reference laboratory method provides the "truth."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is primarily relevant for imaging diagnostics where human interpretation is a key component, often assisted by AI. The Glucometer® is a direct measurement device.

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

Yes, a standalone performance evaluation was conducted. The studies described evaluating the "GLUCOMETER ELITE XL Blood Glucose Meter" and the "GLUCOMETER ELITE Blood Glucose Test Systems" without any mention of human-in-the-loop assistance. The device itself performs the measurement.

7. The Type of Ground Truth Used

The type of ground truth used would have been a laboratory reference method for glucose measurement, which is the standard for validating blood glucose meters. The text implies this by stating the device is "referenced to give plasma/serum equivalent glucose results," indicating comparison to a recognized gold standard.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. For a device like a blood glucose meter, there isn't typically a "training set" in the machine learning sense. Performance is assessed against known reference values, and the device's chemical-electrical design determines its accuracy, not an algorithm "trained" on data for an initial release.

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

Since there is no mention of a "training set" in the context of this device's submission, there is no information on how its ground truth was established.

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The GLUCOMETER Elite XL Blood Glucose Meter is used with GLUCOMETER Elite® Test Strips and Controls for the measurement of glucose in whole blood. The GLUCOMETER Elite System is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

The GLUCOMETER Elite XL System consists of an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the GLUCOMETER Elite® XL Blood Glucose Meter:

It's important to note that the provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing exhaustive detail on the full validation study. Therefore, some information, particularly granular details on acceptance criteria and specific performance metrics, is limited.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the GLUCOMETER Elite XL Blood Glucose Meter, as presented in this 510(k) summary, is its equivalence in performance to the predicate device, the GLUCOMETER Elite Blood Glucose Meter. The summary explicitly states: "The results of the evaluation of the GLUCOMETER Elite XL Blood Glucose Meter demonstrate that the new meter is equivalent in performance to the predicate device and suitable for its intended use."

Specific numerical acceptance criteria and their corresponding reported performance values are not explicitly detailed in the provided document. The summary focuses on the comparative nature of the study.

Study Details

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

   Acceptance Criteria	Reported Device Performance
   Equivalence in performance to the predicate device (GLUCOMETER Elite Blood Glucose Meter)	The GLUCOMETER Elite® XL Blood Glucose Meter was demonstrated to be equivalent in performance to the predicate device. The algorithm was modified to provide greater accuracy at low glucose concentrations, suggesting an improvement in this specific aspect while maintaining overall equivalence.

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

   • Sample Size for Test Set: Not explicitly stated. The document mentions the evaluation was "conducted at two clinical sites."
   • Data Provenance: The study was "conducted at two clinical sites," implying a prospective study. The country of origin is not specified, but the submitter is Bayer Corporation, located in Elkhart, IN, USA, suggesting the clinical sites were likely in the USA. The study involved "diabetics and healthcare professionals," indicating real-world usage.

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 given text. For a blood glucose meter, ground truth is typically established using a laboratory reference method, not by human experts.

4. Adjudication method for the test set:

   • This information is not provided in the given text.

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:

   • No, this was not a MRMC comparative effectiveness study in the context of AI. This device is a blood glucose meter, which is a standalone measurement device, not an AI-assisted diagnostic tool that human readers would interact with. The study compared the new meter to a predicate meter.

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

   • Yes, the primary study described is a standalone performance assessment of the GLUCOMETER Elite XL Blood Glucose Meter itself. The device measures blood glucose directly, and its performance (accuracy, precision) is evaluated intrinsically, rather than in conjunction with human interpretation of its outputs. The evaluation demonstrated the equivalence of the meter to the predicate device.

7. The type of ground truth used:

   • The type of ground truth is implied to be a laboratory reference method for blood glucose measurement. While not explicitly stated, clinical evaluations of blood glucose meters always compare the device's readings against a highly accurate and precise laboratory standard (e.g., hexokinase method, glucose oxidase method on a central lab analyzer). The predicate device's performance would also have been established against such a standard.

8. The sample size for the training set:

   • This information is not applicable and therefore not provided. The GLUCOMETER Elite XL Blood Glucose Meter is an electrochemical method-based meter. While it has an "algorithm modified to provide greater accuracy at low glucose concentrations," this typically refers to a fixed set of mathematical operations or calibrations rather than a machine learning algorithm requiring a separate "training set" in the modern AI sense. Devices like this are calibrated and validated, not "trained" with a large dataset in the way an AI model is.

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

   • This information is not applicable as there is no mention of a "training set" in the context of AI for this device. The "algorithm modification" would have been developed and refined using standard engineering and calibration techniques, likely with reference to precise lab measurements of glucose at various concentrations.

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