The IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. 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.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

This system offers Bluetooth wireless communication function which is able to transfer historical data in the memory to other devices, such as PC or IDEAL LIFE POD™

Device Description

IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

AI/ML Overview

The provided document is a 510(k) summary for the IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and concludes that it demonstrates satisfactory performance. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth establishment methods that would be required to fully answer your questions.

Therefore, I cannot provide a complete answer based solely on the provided text. I can, however, extract the information that is present and highlight what is missing.

Here's a breakdown of what can and cannot be answered:

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

Acceptance Criteria: Not explicitly stated in the provided text. Blood glucose monitoring systems typically have specific accuracy criteria (e.g., ISO 15197 standards), but these are not listed.
Reported Device Performance: The document only states, "The studies demonstrated that the performance of this system meets its intended use" and "IDEAL LIFE Gluco-Manager ™ GMM 0001 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use." No quantitative performance data (e.g., accuracy, precision, bias, MARD) is provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any test set.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users."

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)

Ground Truth Experts: The document states "clinical settings by healthcare professionals and lay users," but it does not specify how many healthcare professionals were involved or their qualifications for establishing ground truth, nor does it explicitly mention ground truth methods for lay user data. For blood glucose monitoring, ground truth is typically established by laboratory reference methods, not by expert consensus on visual inspection or interpretation.

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

Adjudication Method: Not specified. This concept (e.g., 2+1, 3+1) is more relevant to human interpretation of images or other subjective data, not typically for objective measurements like blood glucose where a reference method serves as the ground truth.

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

MRMC Study: Not applicable or mentioned. This is a blood glucose monitoring system, not an AI-powered diagnostic imaging device that assists human readers.

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

Standalone Performance: Yes, implicitly. The "Performance Studies" section refers to the system's performance, which measures the accuracy of the device itself (meter + test strips) against reference methods. While users operate the device, the core performance measured is the algorithm's ability to accurately quantify glucose from the provided sample. The document does not detail these studies.

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

Type of Ground Truth: Not explicitly stated, but for blood glucose monitoring systems, the ground truth is overwhelmingly a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). The document mentions "in the laboratory," which implies such reference methods would have been used.

8. The sample size for the training set

Training Set Sample Size: Not applicable/not mentioned. This device is an electrochemical blood glucose meter, not a machine learning or AI algorithm that undergoes a "training" phase in the conventional sense with a distinct training set. Its "training" is in its design and calibration, which would be validated through the performance studies.

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

Training Set Ground Truth Establishment: Not applicable, as there's no explicitly defined "training set" in the context of an AI/ML algorithm. Calibration and validation data would have been compared against laboratory reference methods.

In summary, the provided document serves as a high-level summary for regulatory submission, confirming the device's technical characteristics and intended use. It does not contain the detailed technical data or study methodologies needed to answer specific questions regarding acceptance criteria, performance metrics, sample sizes, or ground truth establishment in a quantitative manner. Such information would typically be found in the full 510(k) submission, not the public summary document.

Summary

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KOSORS3

JUN 2 7 2008

510 (k) Summary

Page 1-of-3

Submitter Information Company name Contact person Address

Phone FAX E-mail Date Prepared

Name of Device Trade Names

Common Names/Descriptions

Classification Names

TaiDoc Technology Corporation Yuhua Chen · 6F, No. 127, Wugong 2nd Rd, Wugu Township, Taipei County, 248, Taiwan (886-2) 6625-8188 (886-2) 6625-0288 yuhua.chen@taidoc.com Jan 18t , 2008

IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)

Predicate Device Trade/Proprietary Name:

Common/Usual Name:

Manufacturer 510 (k) Number ACHTUNG Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K061181

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4. Device Description

5. Intended Use

IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).

The alternative site testing (the palm, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.

This system offers Bluetooth wireless communication function which is able to transfer historical data in the memory to other devices, such as PC or IDEAL LIFE POD™

6. Comparison to Predicate Device

IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System has equivalent technological characteristics as the ACHTUNG blood glucose monitoring system (K061181). IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System also has the same intended use as the ACHTUNG blood glucose monitoring system

7. Performance Studies

The performance of IDEAL LIFE Gluco-Manager ™ GMM 0001 Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.

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8. Conclusion

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IDEAL LIFE Gluco-Manager ™ GMM 0001 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with healthcare, alongside the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem. The caduceus is depicted with a modern, abstract design, featuring three curved lines that resemble a stylized bird or wing-like shape. The text is in uppercase letters and is positioned to encircle the caduceus, creating a seal-like appearance.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Taidoc Technology Corporation c/o Yuhua Chen Specialist of Regulatory Affairs 6F, No. 127, Wugong 2nd Rd. Wugu Township, Taipei County 248 Taiwan

JUN 2 7 2008

Re: K080283

Trade Name: IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: June 25, 2008 Received: June 25, 2008

Dear Yuhua Chen:

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) 276-0490. 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 tollofree mober (800) 638-2041 от (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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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JUN 2 7 2008

Indications for Use

510(k) Number: K

K080283

Device Name: IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System

Indications for Use:

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

This system offers Bluetooth wireless communication function which is able to transfer historical data in the memory to other devices, such as PC or IDEAL LIFE POD™

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

Over-The-Counter Use_X (21 CFR 807 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)

Division Sign-Off

of in Viro Diac

SIOki K08093

Page 1 of

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.