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The TheraSense, Inc., FreeStyle 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and 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 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 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 (bee) 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 liguid crystal display (LCD).

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

The provided document, a Premarket Notification Labeling Modification for the FreeStyle Blood Glucose Monitoring System, is very brief and does not contain the detailed information requested about acceptance criteria and comprehensive study results. It primarily focuses on the labeling modification to include the palm as an alternative test site.

Therefore, many of the requested fields cannot be filled from the given text.

Here's what can be extracted:

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

The document does not explicitly state acceptance criteria in terms of accuracy or precision metrics for the blood glucose monitoring system itself. It only mentions a clinical study performed to support a labeling change.

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 a "clinical study data," but does not provide details on:

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin).
• Study design: It states "The clinical study data demonstrate... This study confirms results in several published reports...", which implies it was a prospective study conducted to gather new data to confirm existing literature, but does not explicitly state "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)

Not applicable. This is a blood glucose monitoring system, and the "ground truth" for glucose levels is typically established by a reference laboratory method, not by expert interpretation. The text does not describe the method for establishing reference glucose values.

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

Not applicable. Adjudication methods are typically used when subjective interpretations are involved (e.g., reading medical images). For quantitative measurements like blood glucose, adjudication of results is generally not performed in this manner.

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

Not applicable. This is a standalone medical device (blood glucose meter), not an AI-assisted diagnostic tool involving human readers interpreting outputs.

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

Yes, the device itself (the FreeStyle Blood Glucose Monitoring System) is a standalone measurement device. It provides quantitative glucose readings directly. The study mentioned focuses on comparing glucose values obtained from different body sites using this standalone device.

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

The document does not explicitly state the "ground truth" method used for the glucose measurements. For blood glucose meters, the ground truth is typically established by an accurate laboratory reference method (e.g., YSI analyzer). The study aimed to show equivalence between two measurement sites, rather than absolute accuracy against an external gold standard.

8. The sample size for the training set

Not applicable. This document describes a clinical study for a traditional medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for an AI/ML model described here.

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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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