GlucoBalance™ Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

Device Description

The GlucoBalance Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. The subject device consists of a data transfer cable and software. The system allows the user to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. It should be noted that the software does not recommend any medical treatment or medication dosage level.

AI/ML Overview

The provided text describes the 510(k) submission for the GlucoBalance Data Management Software. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a definitive study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document generally refers to "appropriate functional characteristics" and "ease of operation by in-home users."	"demonstrate appropriate functional characteristics" "demonstrated the systems ability to be easily operated by in-home users."

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

Sample size: Not specified. The document mentions "consumer studies" but does not give a sample size.
Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

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

Not applicable. This device is data management software, not a diagnostic tool where expert ground truth would typically be established for classification tasks. The "ground truth" here would likely be the accurate transfer and display of blood glucose data, validated against the meter's internal memory or direct meter readings.

4. Adjudication method for the test set

Not applicable/Not specified. Given the nature of the device (data management software), an adjudication method as typically applied in diagnostic image analysis or similar fields is unlikely to be relevant or detailed here.

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

No MRMC comparative effectiveness study was done or reported. This device is data management software, not an AI-powered diagnostic tool, so this type of study is not relevant.

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

Yes, implicitly. The "performance testing to demonstrate appropriate functional characteristics" and "validation of the systems hardware (the data transfer cable) and software" likely represent standalone testing of the device's ability to transfer, store, and display data correctly. The "consumer studies" for ease of operation would involve human interaction but not in the sense of "human-in-the-loop performance" for a diagnostic algorithm.

7. The type of ground truth used

The ground truth would be the accurate representation of blood glucose data as recorded by the blood glucose meters. This would involve comparing the data downloaded and displayed by the GlucoBalance software against the raw data stored in the connected blood glucose meters, or potentially against manual readings/logs. This is an accuracy assessment of data transfer and display, not a clinical outcome or pathology ground truth.

8. The sample size for the training set

Not applicable/Not specified. This is software for data management, not a machine learning model that requires a training set in the conventional sense. Software development involves testing, but not typically "training sets" as understood in AI/ML contexts.

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

Not applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document states that the device underwent "Safety Testing: performance testing to demonstrate appropriate functional characteristics." This included:

Validation of the system's hardware (the data transfer cable).
Validation of the software.
Consumer studies "that demonstrated the systems ability to be easily operated by in-home users."

The conclusion drawn from this testing was that "The GlucoBalance Data Management Software is substantially equivalent to the Camit Data Management System from Roche Diagnostics Corp. (K001907)." This implies that the performance in these unspecified tests was deemed sufficient to meet the FDA's requirements for substantial equivalence.

In essence, the provided document offers a high-level summary of testing but lacks the granular details typically present in a full study report to address all your specific questions.

Summary

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K02254/5
OCT 11 2002

SECTION 2. SUMMARY AND CERTIFICATION

A. 510(k) Summary
Submitter:	Hypoguard USA, Inc.
Contact Person:	Bruce A. MacFarlane, Ph.D.,Vice President, Regulatory Affairs and Quality SystemsHypoguard USA, Inc.5182 West 76th Street,Minneapolis, MN 55439Phone: (952) 646-3188Fax: (952) 646-3110
Date Prepared:	July 31, 2002
Trade Name:	GlucoBalance Data Management Software
Classification Nameand Number:	Glucose Test System, Class II, 21 CFR 862.1345
	Calculator/Data Processing Module, Class I, 21 CFR 862.2100
Product Codes:	CGA, NBW and JQP
Predicate Device(s):	Camit Data Management System from Roche Diagnostics Corp.(K001907).
Device Description	The GlucoBalance Data Management Software is an optionalaccessory for use with Hypoguard blood glucose meters with datamanagement capabilities. The subject device consists of a datatransfer cable and software. The system allows the user todownload blood glucose results from their glucose meter to theircomputer, maintain a history of their glucose test results, andconvert them into graphs, charts and reports. It should be notedthat the software does not recommend any medical treatment ormedication dosage level.
Intended Use:	Intended Use: GlucoBalance™ Data Management Software is anoptional accessory for use with Hypoguard blood glucose meterswith data management capabilities. GlucoBalance transfers datafrom the meter's memory into a computer for enhanced datamanagement. GlucoBalance is intended for use in home andclinical settings to assist people with diabetes and their health care

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professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

Functional and Representative samples of the subject device underwent Safety Testing: performance testing to demonstrate appropriate functional characteristics. The testing included validation of the systems hardware (the data transfer cable) and software as well as consumer studies that demonstrated the systems ability to be easily operated by in-home users.

Conclusion: The GlucoBalance Data Management Software is substantially equivalent to the Camit Data Management System from Roche Diagnostics Corp. (K001907).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bruce A. Mac Farlane, Ph.D. Vice President Regulatory Affaris and Quality Systems Hypoguard USA, Inc. 5182 West 76th Street Minneapolis, MN 55439

OCT 11 2002

K022545 Re:

Trade/Device Name: GlucoBalance Data Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: July 31, 2002 Received: August 1, 2002

Dear Dr. MacFarlane:

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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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 1 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/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

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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Indications For Use Page

510(k) Number (if known): K022545

Device Name: GlucoBalance Data Management Software

Indications for Use:

Intended Use: GlucoBalance™ Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

prescription

(Division Sign-Off)

✓

over the counter

sion of Clinical Labo 510(k) Number

(Optional Format 3-10-98)

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.