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.

Device Description

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.

AI/ML Overview

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."

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Likely related to accuracy/precision against laboratory reference values (e.g., ISO 15197 standards would typically apply for BGMs).	Document states "correlate well with the laboratory reference glucose values." No specific metrics provided.

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.

Summary

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2006 MAR 9

510(k) Summary

This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(k) number is K051839.

Company	Abbott Diabetes Care Inc.
Street Address	1360 South Loop Road
City, State Zip	Alameda, CA 94502
Phone	510-749-6475
Contact Person:	Dhruma Shahdhruma.shah@abbott.com
Proprietary Name:	FreeStyle Freedom™ Blood Glucose MonitoringSystem
Common Name:	Blood Glucose Testing System
Classification Number:	21 CFR §862.1345
Predicate Device:	FreeStyle Blood Glucose Monitoring System
Date Prepared:	July 1, 2005

Description of the Device:

Intended Use of the Device:

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.

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Comparison to Predicate Device:

	Predicate Device	Subject (modified) Device
Company	Abbott Diabetes Care Inc	Same
510(k) Reference	K992684, K000582, K012014,K031260, K050500	Current Submission
Proprietary Name:	FreeStyle Blood GlucoseMonitoring System	FreeStyle FreedomTM BloodGlucose Monitoring System
Common Name:	Blood Glucose Testing System	Same
Classification Number:	21 CFR §862.1345	Same
Intended Use	Quantitative measurement ofblood glucose concentrations	Same
Single Use?	No	Same
Sterilized?	No	Same

Differences from Predicate Device

ModificationDescription	FreeStyle	FreeStyleFreedom
LCD size change	30.5 mm Width27.5 mm Height	28.5 mm Width34.5 mm Height
Alarm mode	Not included	4 programmable alarmsettings
Lock unit ofmeasure forGlucose reading	User selectable unitof measure (mg/dLor mmol/L)	Unit of measure set toeither mg/dL or mmol/Lat manufacturer
GlucoseMeasurementAssay Time	Average 7 seconds	Average 5 seconds

Performance Studies:

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.

Conclusion:

Results of laboratory and clinical testing demonstrate that the performance of the FreeStyle Freedom™ Blood Glucose Monitoring System is substantially equivalent to the performance of the predicate devices for blood glucose testing and suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

MAR 9

2006

Dhruma Shah Regulatory Affairs Associate Abbott Laboratories/TheraSense Inc. Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

Re: K051839

Trade/Device Name: FreeStyle Freedom™ Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: January 20, 2006 Received: January 23, 2006

Dear Ms. Shah:

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 Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number : K051839

Device Name: FreeStyle Freedom™ Blood Glucose Monitoring System

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use V (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Alberto S
Division Sign-Off

Office of In Vitro Diagn Device Evaluation and

510(k) K051839

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.