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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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