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

The FreeStyle Freedom™ 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 Freedom™ monitor utilizes coulometric biosensor technology found in the FreeStyle Freedom test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Freedom 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 text is a 510(k) summary for a blood glucose monitoring system. It primarily focuses on the substantial equivalence of the FreeStyle Freedom system to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with the specific metrics requested.

Therefore, much of the requested information cannot be extracted directly from the provided document.

Here's an attempt to answer the questions based on the available information:

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

The document states, "The performance of the FreeStyle Freedom Blood Glucose Monitoring System was evaluated in laboratory studies as well as accuracy and lay user clinical studies. Data from the clinical studies demonstrates that lay users can obtain results from the FreeStyle Freedom Blood Glucose Monitoring System that correlate well with the laboratory reference glucose values."

However, specific numerical acceptance criteria (e.g., accuracy percentages, bias thresholds) and the corresponding reported performance values are not provided in this summary. It concludes generally that the performance "is substantially equivalent to the performance of the predicate devices for blood glucose testing and suitable for its intended use."

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 mentions "accuracy and lay user clinical studies" and "clinical testing" but does not provide any details about the sample size for these studies or the test set.

• Sample Size (Test Set): Not specified.
• 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 (e.g., radiologist with 10 years of experience)

The document refers to "laboratory reference glucose values" as the comparator for the device's performance. However, it does not specify the number or qualifications of experts involved in establishing these laboratory reference values.

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

The document does not describe any adjudication method for establishing ground truth, as it primarily relies on "laboratory reference glucose values."

• Adjudication method: Not applicable/Not specified for this type of device and study description.

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 device is a blood glucose monitoring system, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of device and was not mentioned.

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

The device is a standalone blood glucose meter that provides a numerical reading. Its performance is inherently "standalone" in the sense that the algorithm (biosensor technology) directly provides the glucose measurement. The clinical studies evaluate how well these results compare to laboratory methods when used by lay users.

• Standalone Performance: Yes (the device measures glucose concentration directly). The "lay user clinical studies" evaluate its performance when used by humans in a real-world scenario, but the core measurement is a standalone algorithmic result.

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

The ground truth for evaluating the device's performance was "laboratory reference glucose values." This typically refers to measurements obtained using a highly accurate and precise laboratory analyzer (e.g., a YSI analyzer) in a controlled setting.

• Type of Ground Truth: Laboratory reference glucose values.

8. The sample size for the training set

The document does not mention a "training set" as this is a traditional medical device (biosensor) and not explicitly an AI/machine learning model in the contemporary sense that would require distinct training/validation/test sets for algorithm development. The performance studies described are for validation/testing of the final device.

• Sample Size (Training Set): Not applicable/Not specified.

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

As there is no mention of a "training set" for AI/ML model development, this information is not applicable. The ground truth for performance evaluation was "laboratory reference glucose values" as noted in question 7.

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The FreeStyle 600 Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle 600 Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle 600 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and a Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.

When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liquid crystal display (LCD).

Here's an analysis of the provided text regarding the FreeStyle 600 Blood Glucose Monitoring System, detailing the acceptance criteria and study information:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the FreeStyle 600 Blood Glucose Monitoring System outlines its performance studies and a general conclusion of acceptability and comparability to a comparative method. However, specific quantitative acceptance criteria (e.g., accuracy percentages, precision metrics) and detailed reported performance metrics are not explicitly stated in the summary. The summary focuses more on the type of studies conducted and the conclusion of substantial equivalence rather than granular performance data against predefined thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria were not found in the provided text, the table below reflects what was implied and the general conclusion provided.

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

• Sample Size for Test Set: Not explicitly stated. The summary mentions "Performance Studies" conducted in "the laboratory and in clinical settings."
• Data Provenance: The studies were conducted in "the laboratory and in clinical settings by healthcare professionals." The country of origin is not specified, but the submission is to the U.S. FDA, implying the studies were likely conducted in the U.S. or followed U.S. regulatory guidelines. The summary does not specify whether the data was retrospective or prospective.

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

• Number of Experts: Not explicitly stated. The studies were conducted "by healthcare professionals," implying multiple individuals were involved in the clinical settings, but the exact number or their specific roles in establishing ground truth (e.g., as a reference method operator) are not detailed.
• Qualifications of Experts: Not explicitly stated. They are referred to as "healthcare professionals."

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The summary mentions results being "substantially equivalent to a comparative method," but the process by which "ground truth" was established or adjudicated is not described.

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

• MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, not an imaging or diagnostic AI system that typically involves multiple human readers interpreting results. The study design described is focused on the device's accuracy against a recognized reference method.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: The study inherently reflects standalone performance of the device system. The FreeStyle 600 Blood Glucose Monitoring System operates by taking a blood sample and displaying a glucose reading. The "performance studies" would evaluate the accuracy of this system (meter + strips) against a reference method. There is no separate "human-in-the-loop" component in the direct operation of this type of device that would differentiate between an algorithm-only performance and an assisted performance.

7. Type of Ground Truth Used

• Ground Truth Type: A "comparative method" was used. For blood glucose monitoring systems, this typically refers to a highly accurate laboratory reference method for measuring blood glucose, such as a YSI glucose analyzer. The summary states that the device's performance was "substantially equivalent to a comparative method."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not mentioned. The provided summary is for a traditional medical device (blood glucose meter) which does not typically involve machine learning or AI models with distinct "training sets" in the conventional sense. The device's calibration and algorithm are established during its development and manufacturing, not through a separate "training set" of patient data as seen in AI/ML products.

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

• Ground Truth for Training Set: Not applicable. As explained above, for this type of device, there isn't a "training set" with established ground truth in the same way as an AI/ML model. The device's accuracy is validated against reference methods during its development and performance studies.

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The TheraSense, Inc. FreeStyle Tracker Diabetes Management 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.

Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program.

The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf, and hand.

The FreeStyle Tracker Diabetes Management System combines and joins the technologies and capabilities of both the FreeStyle Blood Glucose Monitoring System (blood glucose measurement testing system) and the FreeStyle Connect Data Management System (data management accessory software). Through the use of a Personal Digital Assistant (PDA), the user is able to conveniently log glucose measurements directly to a log history on the PDA. The Tracker System eliminates the necessity for manual data logs and separate tools for calculating values, storing results and producing and maintaining critical medical records. The blood glucose meter and data management system components of the Tracker System can also be used independently as separate features.

The items that comprise the FreeStyle Tracker Diabetes Management System are as follows:

• . FreeStyle Tracker Measurement Module
• Personal Digital Assistant (PDA) .
• . "Hot-sync" Cradle
• FreeStyle Tracker Data Management Software .

Additionally, in order to perform a blood glucose test the Tracker System requires the following items. These items are the same as those needed for the current FreeStyle System:

• . FreeStyle Test Strips
• FreeStyle Lancing Device .
• FreeStyle Lancets ●
• FreeStyle Control Solution .

To perform a blood glucose measurement, the user removes the cover of the Visor PDA expansion slot and inserts the Tracker Measurement Module into the Visor PDA Handspring slot. The user then inserts a test strip into the Measurement Module. The user acquires a blood sample (with the test strip in the meter) by touching the edge of the test strip to the blood target area, filling the chamber on the strip by capillary action. The Tracker System sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. The test is complete and the meter displays the glucose reading on the PDA display.

The Tracker Data Management Systems also gives the ability to conveniently access and maintain diabetes data through the Visor PDA and/or PC. The user can easily and conveniently track major factors that affects their diabetes health, for example:

• Blood glucose levels
• . Insulin usage (via injection or pump)
• . Food intake
• Exercise .
• . Oral medication usage
• . State of health

The Tracker DMS will also allow the user to enter personal factors used to maintain their proper glucose level. The following items assist the user to track and modify their lifestyle as it affects their diabetes health:

• Target glucose range .
• o Usual insulin type
• . Typical insulin dose
• . Insulin adjustment guidelines (determined by his/her healthcare professional)
• . Meal schedule and guidelines (determined by his/her healthcare professional)
• . Typical exercise type, duration and intensity

The provided document describes the FreeStyle Tracker Diabetes Management System, a device that combines a blood glucose monitoring system with data management software. It is a modification of previously cleared devices and is intended for quantitative measurement of glucose in whole blood for individuals with diabetes and healthcare professionals.

However, the provided text does not contain specific acceptance criteria (e.g., accuracy metrics like MARD or percentage within certain error zones) or a detailed study report with performance data. It summarizes that system and component testing was performed to ensure equivalence to currently marketed devices and that changes did not affect safety or effectiveness. The FDA letter confirms substantial equivalence but does not detail performance against specific criteria.

Therefore, many of the requested items cannot be extracted from the provided text.

Here's an attempt to answer based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing "ensured the new device is equivalent" and "demonstrat[ed] that the resultant changes have not affected safety or effectiveness." However, it does not specify quantitative acceptance criteria or the performance values achieved for these criteria. For example, it does not state "95% of readings within ±X mg/dL of laboratory reference" or similar.

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

• Test set sample size: Not specified. The document mentions "system, hardware, software, mechanical, packaging, electrical safety (EMC, EMI, and ESD) and clinical (user's study and labeling comprehension) evaluations" but does not detail the sample sizes for these tests.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.
• Establishment of ground truth: The document does not describe how ground truth was established for the "clinical (user's study and labeling comprehension) evaluations." For blood glucose devices, ground truth for glucose measurements is typically established against a laboratory reference method, but this is not detailed for the FreeStyle Tracker in this summary.

4. Adjudication method for the test set

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• An MRMC study is not mentioned. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool where MRMC studies are common. The data management software component assists users but is not described as an "AI" in the context of improving human reader performance in interpreting complex medical images.

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

• The FreeStyle Tracker Measurement Module functions as a standalone blood glucose meter in that it measures glucose directly. The entire system is designed with a user in the loop for performing the test and reviewing data. Performance of the algorithm (the glucose measurement technology) is implied to be equivalent to the predicate FreeStyle Blood Glucose Monitoring System, but specific standalone performance metrics are not given.

7. The type of ground truth used

• Not explicitly stated for the "clinical evaluations." For blood glucose measurements, the ground truth is typically a laboratory reference method (e.g., YSI analyzer). For the "user's study and labeling comprehension," ground truth would relate to successful task completion or understanding, but the method for determining this is not detailed.

8. The sample size for the training set

• Not applicable as this document describes a device modification with testing focused on equivalence, rather than the development of a novel algorithm that requires a distinct training set (in the machine learning sense). The underlying technology is stated to be unchanged from the predicate device.

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

• Not applicable for the reasons mentioned above.

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