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The FreeStyle Lite Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.

The FreeStyle Lite Meter, in conjunction with the FreeStyle Lite Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.

The FreeStyle Lite Meter consists of the following major features:

• Strip Port where the FreeStyle Lite Test Strip is inserted. ●
• . Buttons - used to turn the meter on/off and recall information stored in the meter.
• . Display Window - where test results, messages and information stored in the meter appear.

The device is prepared for use by inserting a glucose test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The meter will then display the time, month and day (if set). The 'apply blood' message is displayed for the user to apply blood to the test strip until the meter begins the test. Blood detect will occur when the meter detects trigger current from the test strip, initiated when enough blood has covered the strip electrodes. Following the blood detect, the meter performs the glucose assay measurement.

The provided document is a 510(k) summary for the FreeStyle Lite Blood Glucose Monitoring System. It outlines the device's indications for use, description, principles of operation, and a comparison to a predicate device.

However, the document does not contain specific acceptance criteria tables, reported device performance data, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case study results, standalone performance study results, or training set information.

The primary focus of this submission is to incorporate new cleaning and disinfection procedures. Therefore, the performance studies mentioned near the end of the document likely pertain to the stability and accuracy of the device after repeated cleaning and disinfection cycles, rather than a general performance evaluation of the glucose measurement accuracy itself.

Without the specific performance study report, I cannot fulfill all parts of your request. I can, however, extract what is available regarding the cleaning and disinfection aspects, which seem to be the core of this particular submission's changes.

Here's a summary of the information that is available in the provided text, related to the device's characteristics and the changes in cleaning/disinfection:

1. Acceptance Criteria and Reported Device Performance:

Based on the "Differences" section, the main change and associated performance pertains to the cleaning and disinfection procedures.

Note: The document states "The results obtained from performance studies demonstrate that the FreeStyle Lite Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K092602)." This implies the device maintained its intended performance after these cleaning/disinfection cycles, but specific accuracy data post-disinfection is not provided in this summary. |
| Lancing Device Cleaning/Disinfection:
Effectiveness and durability of the lancing device after extended cleaning and disinfection cycles. | The lancing device was tested for 210 cleaning and 210 disinfection cycles (stated as the equivalent of 2 cycles per week for 2 years) using Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12.

Note: Similar to the meter, the document implies the lancing device remained safe and effective after these cycles. |

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

• Test Set Sample Size: Not specified in the provided text. The number of cleaning/disinfection cycles (522 for meter, 210 for lancing device) refers to the duration/intensity of the test, not the number of individual devices or patients in a test set.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/not specified, as this document focuses on device cleaning/disinfection performance rather than diagnostic accuracy requiring expert ground truth in the typical sense.

4. Adjudication method for the test set:

• Not applicable/not specified.

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 device is a blood glucose monitoring system, not an AI-assisted diagnostic tool.

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

• Yes, effectively. The "performance studies" mentioned would have evaluated the device's physical integrity and functional accuracy after the cleaning/disinfection procedures. This constitutes a standalone performance evaluation of the device itself under specific conditions. However, the specifics of how "performance" was measured (e.g., whether glucose accuracy remained within specifications) are not detailed in this summary.

7. The type of ground truth used:

• For the cleaning/disinfection changes, the "ground truth" would be the device's ability to maintain its specified performance and physical integrity (e.g., no degradation of materials, continued accurate glucose measurements) after the specified number of cleaning/disinfection cycles. The detailed technical reports for these studies (not included here) would have defined the pass/fail criteria for this performance.
• For the core glucose measurement function, the "ground truth" would typically be a reference method for glucose concentration, against which the device's readings are compared for accuracy. This information is usually detailed in the original 510(k) for the device's core functionality (K092602, the predicate).

8. The sample size for the training set:

• Not applicable/not specified, as this is not an AI/machine learning device requiring a training set in that context. If "training set" refers to data used to validate the core glucose measurement, that information is not in this document.

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

• Not applicable/not specified for the reasons above.

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The FreeStyle Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm; and venous blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

The FreeStyle Freedom Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm; and venous blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

A chemistry change has been made to the FreeStyle Lite Blood Glucose Test Strip. The modified strip is to be marketed under the brand name. FreeStyle Lite, and is intended for use with the following Blood Glucose Monitoring Systems: FreeStyle Lite Blood Glucose Monitoring System, FreeStyle Freedom Lite Blood Glucose Monitoring System. The meters and other system components contained within these systems have not been modified. Each of the aforementioned blood glucose monitoring systems are comprised of a handheld glucose meter, glucose reagent test strips, a quality control solution, a lancing device, lancets, lancing cap, and labeling for performing a blood glucose test. The intended uses and principles of operation for each of the systems remains the same as previously submitted and cleared for market entry. The systems utilize coulometric biosensor technology to quantitatively measure glucose concentration in whole blood samples. The systems are intended for selfmonitoring of glucose in capillary and venous whole blood. The primary users are persons with diabetes. The systems are meant to aid in diabetes management and for healthcare professionals to aid in monitoring the effectiveness of diabetes control program. The FreeStyle Lite Blood Glucose Test Strip is an electrochemical biosensor that fits into a handheld meter. The blood sample volume is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger, upper arm, or palm. Test results display in accordance with the blood glucose meter's software algorithm (approximately 5 seconds). The internal volume of the test strip is precisely controlled, and a blood glucose result will not be displayed on the meter unless the internal sample chamber is filled. Once the measurement begins, the glucose is rapidly oxidized by the reagents that are present in the inside of the sample chamber. The electrochemical signal that results from this process depends only on the total amount of glucose present. The reagent chemistry enables electrolysis of glucose in the blood sample. A mediator molecule shuttles electrons rapidly between a glucose-oxidizing enzyme and the working electrode on the strip. The mediator is capable of reacting rapidly with both the electrode and the enzyme, resulting in a rapid reaction time and minimizing the total amount of mediator required. The small mediator load results in high accuracy at the low end of the glucose measurement range.

The provided text describes a 510(k) summary for the FreeStyle Lite Blood Glucose Test Strips, which are part of the FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Monitoring Systems. The submission is for modifications to the test strip chemistry, materials, appearance, and meter turn-on bar.

Here's an analysis of the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format or provide a direct comparison to "reported device performance." Instead, it describes modifications to existing, cleared devices and indicates that the "intended uses and principles of operation for each of the systems remains the same as previously submitted and cleared for market entry." This implies that the new strips are expected to meet the performance standards of the previously cleared systems.

However, the text indicates the reason for modification and implicitly, the performance benefit:

Note: The document does not provide quantitative performance data (e.g., accuracy percentages, bias, precision) for either the original or modified device in this summary. It focuses on the change and its expected benefits regarding carbohydrate interference.

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

The provided text does not contain information about the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The provided text does not contain information about the number of experts used to establish ground truth or their qualifications. This type of information is typically associated with studies involving diagnostic image interpretation or complex clinical assessments, not typically for glucose monitor performance data as described here.

4. Adjudication Method for the Test Set

The provided text does not contain information about any adjudication method.

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

The provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more relevant to diagnostic imaging interpretation by human readers.

6. Standalone (Algorithm Only) Performance Study

The text describes an electrochemical biosensor system. The "algorithm" here refers to the software within the meter that interprets the electrochemical signal to display a glucose reading. The entire system (strip + meter) is designed for direct measurement. The text states: "Test results display in accordance with the blood glucose meter's software algorithm (approximately 5 seconds)." While the meter processes the signal algorithmically, the concept of a "standalone algorithm" performance, separate from the physical measurement, isn't directly applicable in the same way it would be for an AI diagnostic imaging algorithm. The performance of the device (strip + meter) is what would be evaluated. The provided text does not present a standalone performance study with specific metrics.

7. Type of Ground Truth Used

The ground truth for blood glucose monitoring systems like this would typically be established by a reference method (e.g., laboratory-grade glucose analyzer, YSI 2300 STAT Plus Glucose & Lactate Analyzer) measuring the glucose concentration in the same blood sample. The provided text does not explicitly state the type of ground truth used, but this is the standard for glucose meter validation.

8. Sample Size for the Training Set

The provided text does not mention a "training set" or its sample size. For traditional medical devices like blood glucose monitors, there isn't typically a "training set" in the machine learning sense. Performance is generally validated through clinical studies and laboratory testing.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the machine learning context, the provided text does not describe how ground truth for a training set was established.

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The FreeStyle™ Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

The FreeStyle™ Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

The FreeStyle™ Lite Blood Glucose Monitoring System (BGMS) utilizes coulometric biosensor technology found in the FreeStyle Lite test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Lite BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.

The provided document describes a 510(k) premarket notification for the FreeStyle™ Lite Blood Glucose Monitoring System. It states that the device was studied in a laboratory and the results demonstrated substantial equivalence to a predicate device (FreeStyle Freedom™ Blood Glucose Monitoring System, K051839). However, it lacks detailed quantitative acceptance criteria and specific study results.

Here's an attempt to answer your questions based on the available information, noting where details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific reported device performance values. It generally claims the device is "acceptable and comparable" and achieved "substantial equivalence" to the predicate device.

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

The document states that the performance was "studied in the laboratory." It does not provide information on the sample size used for the test set (number of blood samples, number of participants), data provenance (country of origin), or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for blood glucose measurements is typically established by laboratory reference methods, not subjective adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study is not relevant for a blood glucose monitoring system, which provides a quantitative measurement rather than requiring interpretation by multiple readers. The document does not describe such a study.

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

A blood glucose monitoring system inherently performs as a "standalone" device in the sense that the algorithm processes the blood sample and displays a glucose value without human intervention in the measurement process itself. The document describes laboratory testing of the system, which represents its standalone performance.

7. The Type of Ground Truth Used

While not explicitly stated, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer or equivalent). This method provides highly accurate and precise glucose measurements for comparison. The document mentions "laboratory testing," which implies comparison against such a reference.

8. The Sample Size for the Training Set

The document does not provide information about a training set size. For a biosensor of this type, the "training" (calibration) is often built into the manufacturing process of the test strips and meter, rather than requiring a separate "training set" like in machine learning models. If any internal calibration or validation involved a dataset, it is not disclosed here.

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

As no training set is described in the context of machine learning, this question is not directly applicable. If there were internal calibration processes, the ground truth for those would typically be established using highly accurate laboratory reference methods.

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