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The SURESTEP System is for quantitative measurement of glucose in whole blood. It may be used by persons with diabetes in the home and by healthcare professionals in clinical settings as an aid to monitor effectiveness of diabetes control.

The LifeScan SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer, and a quality control solution. A lancing device and lancets are also included with the system. The user obtains a blood sample and applies it to the test strip before inserting the strip into the meter. The user obtains a blood sample and applies it to the test strip before inserting the strip into the meter. After inserting the strip into the meter, the glucose value displays on the meter's liquid crystal display (LCD). The test strip color can be compared visually to a color chart provided with the system to estimate if the glucose concentration is very high or very low as a backup to the meter.

When blood is placed on the test strip, glucose in the blood sample reacts with oxygen to yield gluconic acid and hydrogen peroxide. This reaction is catalyzed by the enzyme glucose oxidase present in the test strip. Hydrogen peroxide then reacts with the indicator dye, catalyzed by the presence of peroxidase in the test strip, creating a blue color proportional to the concentration of glucose present in the blood sample. An absorbent layer in the test strip acts as a reservoir for excess blood.

The blood glucose meter is a reflectance photometer that measures the light reflectance of the blue color that develops on the test strip. The meter electronically converts the reflectance data to a digital result that is displayed on a liquid crystal display (LCD). The meter is powered by two 1.5 V AAA alkaline batteries. The user calibrates the meter for each lot number of test strips in use by entering a calibration code specific to that lot number. A quality control solution is included in the system so that the user can check system performance.

This document only provides a 510(k) Summary for the SURESTEP® Blood Glucose Monitoring System, which primarily focuses on establishing "substantial equivalence" to a predicate device. It does not present a detailed study with acceptance criteria and performance data in the way typically expected for a rigorous clinical or performance evaluation study of a new medical device.

Therefore, most of the requested information cannot be extracted from the provided text. The document states that the existing labeling was "reformatted and simplified to increase understanding and provide clear explanations of the performance capabilities and the performance limitations of the system," but it does not provide those performance capabilities or the study details behind them.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

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

This information is not provided in the 510(k) Summary. The summary focuses on comparing the modified device to a predicate device and stating substantial equivalence, not on presenting specific performance data against defined 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)

This information is not provided in the 510(k) Summary. There is no mention of a specific test set or data provenance.

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 information is not provided in the 510(k) Summary. Blood glucose monitoring systems typically use laboratory reference methods (e.g., YSI analyzer) as ground truth, not expert consensus in the same way imaging devices might. However, even the type of ground truth used is not specified.

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

This information is not provided in the 510(k) Summary. Adjudication methods are typically relevant for subjective assessments, which are not usually part of blood glucose meter performance testing.

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 to this type of device (blood glucose meter). This document describes a standalone diagnostic device where the result is read by the user, not an AI-assisted diagnostic intended to improve human interpretation of complex data.

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

Yes, the device described is a standalone device that performs a quantitative measurement of glucose. The user obtains a blood sample, applies it to the test strip, inserts it into the meter, and the glucose value is displayed. This is an "algorithm only" (or rather, a measurement system only) performance in the sense that the meter provides a direct numerical reading without human interpretation of complex images or data that an AI might assist with. However, no specific standalone study details or performance metrics are provided in this summary.

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

This information is not explicitly stated in the 510(k) Summary. For blood glucose meters, the typical ground truth in performance studies is a highly accurate laboratory reference method (e.g., YSI glucose analyzer), but this document does not specify.

8. The sample size for the training set

This information is not provided in the 510(k) Summary. This device is a reflectance photometer based on a chemical reaction, not a machine learning or AI algorithm that would typically have a "training set" in the common sense.

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

This information is not provided as the concept of a "training set" does not directly apply in the context of this device described in the summary.

Summary of what is available from the document:

• Device Name: SURESTEP® Blood Glucose Monitoring System
• Intended Use: Quantitative measurement of glucose in whole blood by persons with diabetes in the home and by healthcare professionals in clinical settings as an aid to monitor effectiveness of diabetes control.
• Predicate Device: SURESTEP Blood Glucose Monitoring System (implying the submission is for a modified version of an existing device).
• Nature of Modification: Labeling reformatted and simplified, and the visual backup system modified by eliminating comparison colors equivalent to 100 mg glucose/dL and 180 mg glucose/dL.
• Conclusion: The modified device is substantially equivalent to the predicate device.

The provided text simply serves as a 510(k) summary for FDA clearance based on substantial equivalence, not a detailed scientific paper outlining a performance study.

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The LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates.

The SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer and quality control materials and may include data transfer or management hardware and/or software tools.

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate the requested table and detailed information based on this input.

The document is a 510(k) summary and approval letter for the LifeScan SURESTEP Blood Glucose Monitoring System, primarily focusing on its substantial equivalence to previously marketed devices and its intended use. There is no mention of performance studies or acceptance criteria within the provided text.

Ask a specific question about this device