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.

Device Description

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

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
System Equivalence	Equivalence to currently marketed FreeStyle Blood Glucose Monitoring System and FreeStyle Connect Data Management Software	"System and component testing was performed with the Tracker Diabetes Management System to ensure the new device is equivalent to the currently marketed devices..." and "...demonstrating that the resultant changes have not affected safety or effectiveness."
Safety & Effectiveness	Maintain safety and effectiveness of predicate devices.	"...demonstrating that the resultant changes have not affected safety or effectiveness."
Hardware	Implicitly, functionality and safety of hardware components.	Included in "system and component testing."
Software	Implicitly, functionality and safety of software components.	Included in "system and component testing."
Mechanical	Implicitly, functionality and safety of mechanical aspects.	Included in "system and component testing."
Packaging	Implicitly, integrity and suitability of packaging.	Included in "system and component testing."
Electrical Safety (EMC, EMI, ESD)	Compliance with relevant electrical safety standards.	Included in "system and component testing."
Clinical (User's Study & Labeling Comprehension)	Implicitly, usability and understanding of instructions.	Included in "clinical... evaluations."

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.

Summary

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TheraSense, Înc. March 15, 2002

KO20866

FreeStyle Tracker Diabetes Management System Special 510(k)- Device Modification

JUN 11 2002

510(k) Summary	JUN 11 2002
Category	Comments
Sponsor:	TheraSense, Inc.1360 South Loop RoadAlameda, CA 94502
Correspondent:	Donna K. TemplemanManager, Regulatory Affairs1360 South Loop RoadAlameda, CA 94502
Contact Numbers:	Phone: (510) 239-2670Fax: (510) 239-2799
Device Common Name	Blood Glucose Meter and Data ManagementSoftware
Device Proprietary Name	FreeStyle Tracker™ Diabetes ManagementSystem
Device Classification Name	Glucose Test SystemBlood Lancet
Device Classification	Glucose Test System per 21 CFR 862.1345,Class II Device
Predicate Device	TheraSense, Inc., FreeStyle Blood GlucoseMonitoring SystemTheraSense, Inc., FreeStyle Connect DataManagement System
Predicate DeviceManufacturer(s)	TheraSense, Inc.
Predicate DeviceReference(s)	K992684; K000582; K012014; K994433
Predicate DeviceProprietary Name(s)	TheraSense, Inc., FreeStyle Blood GlucoseMonitoring SystemTheraSense, Inc., FreeStyle Connect DataManagement System
Predicate DeviceClassification Name(s)	Glucose Test SystemData Management Software
Predicate DeviceClassification(s)	Glucose Test System per 21 CFR 862.1345, ClassII DeviceData Management Software, no classificationexists as of the date of subject device filing.

Date Summary Was Prepared: March 15, 2002.

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc

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Description of the Device:

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 .

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TheraSense, Inc. March 15, 2002

the test strip to the blood target area, filling the chamber on the strip by capillary The Tracker System sounds a tone (beeps) to let the user know that the action. sample chamber is full and the reaction has begun. The test is complete and the meter displays the glucose reading on the PDA display.

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

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc

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Intended Use:

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

Technological

Characteristics:

The fundamental scientific technology of the FreeStyle System has not been modified to result in the Tracker Diabetes Management System. The Tracker Measurement Module contains the same technology as the FreeStyle Meter in that the Tracker Measurement Module measures the electrical output from the glucose in whole blood reacting with the FreeStyle Test Strip chemistry. The measurement is then converted into glucose concentrations and displayed to the user.

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc

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Summary of

Testing:

System and component testing was performed with the Tracker Diabetes Management System to ensure the new device is equivalent to the currently marketed devices (FreeStyle Blood Glucose Monitoring System and FreeStyle Connect Data Management Software). These tests consisted of system, hardware, software, mechanical, packaging, electrical safety (EMC, EMI, and ESD) and clinical (user's study and labeling comprehension) evaluations. The changes to the FreeStyle System have been verified and validated demonstrating that the resultant changes have not affected safety or effectiveness.

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Image /page/5/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services (USA). The logo features a stylized image of a bird or abstract human figure, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service .

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Donna K. Templeman Manager, Regulatory Affairs TheraSense, Inc. 1360 South Loop Road Alameda, CA 94502

JUN 11 2002

Re: K020866

Device Name: FreeStyle Tracker™ Diabetes Management System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW Dated: June 3, 2002 Received: June 4, 2002

Dear Ms. Templeman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TheraSense, Inc. March 15, 2002

Intended Use Statement

510(k) Number (if known): K020866

FreeStyle Tracker Diabetes Management System Device Name:

Indication for Use:

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

Sen Cooper

(Division Sign-Off)
Vision of Clinical Laboratory.......
10(k) Number K020846

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Proprietary Data: This document and the information contained herein may not be reproduced. used or disclosed without prior written consent of TheraSense, Inc.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.