The CLEVER CHOICE Mini 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 people with diabetes mellitus at home and by health care professionals in clinical settings 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 alternative site testing in the above system can be used only during steady-state blood glucose conditions.

Device Description

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only CLEVER CHOICE Mini test strips and CLEVER CHOICE control solutions with the CLEVER CHOICE Mini Blood Glucose Monitoring System.

AI/ML Overview

The provided text is a 510(k) summary for the TaiDoc Technology Corporation's CLEVER CHOICE Mini Blood Glucose Monitoring System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, the document does not contain the detailed acceptance criteria or the specific study data that demonstrates the device meets such criteria.

The crucial section (Section 7, "Performance Characteristics") merely states: "CLEVER CHOICE Mini Blood Glucose Monitoring System has the same performance characteristics as the predicate device. A comparison of system performance demonstrated that the CLEVER CHOICE Mini blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System are substantially equivalent. Software verification and validation testing confirmed that the performance, safety and effectiveness of the CLEVER CHOICE Mini blood glucose monitoring system is equivalent to the predicate device."

This indicates that while performance testing was done, the actual criteria and reported results are not included in this summary. The submission relies on demonstrating equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187) rather than providing a detailed de novo performance study with specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's an attempt to answer what can be inferred or, more importantly, what is missing:

Acceptance Criteria and Device Performance Study Report

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not provided in this document. The document states the device has "the same performance characteristics as the predicate device" and is "substantially equivalent" to it. Specific numerical acceptance criteria (e.g., ISO standards for glucose meters, error grid analysis zones, precision, accuracy ranges) and the device's measured performance against these criteria are absent from this 510(k) summary.	Not provided in this document. The document states that a "comparison of system performance demonstrated that the CLEVER CHOICE Mini blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System are substantially equivalent." No specific performance data (e.g., accuracy, precision, bias) for the CLEVER CHOICE Mini or the predicate device is presented.

Acceptance Criteria

Reported Device Performance

Not provided in this document. The document states the device has "the same performance characteristics as the predicate device" and is "substantially equivalent" to it. Specific numerical acceptance criteria (e.g., ISO standards for glucose meters, error grid analysis zones, precision, accuracy ranges) and the device's measured performance against these criteria are absent from this 510(k) summary.

Not provided in this document. The document states that a "comparison of system performance demonstrated that the CLEVER CHOICE Mini blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System are substantially equivalent." No specific performance data (e.g., accuracy, precision, bias) for the CLEVER CHOICE Mini or the predicate device is presented.

Detailed Study Information (Based on what is and is not in the provided text):

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

Sample size: Not specified.
Data provenance: Not specified. Given it's a Taiwanese company, it's possible the data originated from Taiwan, but this is not stated. The type of study (retrospective or prospective) is also not specified.

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

Not applicable / Not provided. For a blood glucose monitoring system, the "ground truth" (reference method) is typically established by laboratory-grade analyzers (e.g., YSI glucose analyzer) rather than expert consensus on images or interpretations. The document does not specify the reference method used or any experts involved in establishing ground truth.

4. Adjudication method for the test set:

Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or subjective interpretations. For a blood glucose meter, the "truth" is typically determined by an objective, highly accurate reference laboratory method. No such adjudication method is relevant or described for this type of device.

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. This is a blood glucose monitoring system, not an AI-powered diagnostic imaging device. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are not applicable.

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

Not applicable in the AI sense. The device itself is a standalone measurement system. The performance referred to is the accuracy of the glucose measurement by the system (meter + strip). It's an "algorithm only" in the sense that the device outputs a numerical result without human interpretation of the measurement process itself, but it's not an AI algorithm determining a diagnosis or interpreting images. The closest information is that "Software verification and validation testing confirmed that the performance, safety and effectiveness...".

7. The type of ground truth used:

Not specified. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., a YSI analyzer measuring plasma glucose), but this document does not explicitly state the reference method used in the performance comparison.

8. The sample size for the training set:

Not applicable / Not provided. This device is based on electrochemical biosensor technology, not a machine learning model that requires a distinct "training set" in the conventional AI sense. While the device's algorithms are developed and refined, the concept of a "training set" as understood in AI studies is not directly applicable or described here.

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

Not applicable / Not provided. As mentioned above, the concept of a training set with established ground truth, as typically discussed for AI/ML devices, does not apply to this electrochemical blood glucose meter in the context of this 510(k) summary.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria. The specific numerical performance, sample sizes, and detailed methodology of the performance study are not included in this document.

Summary

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Section 11. 510(k) Summary

MAR 2 6 2010

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: K093941

1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondence: Debra Liang Senior Specialist, Regulatory Affairs Tel: +886-2-6625-8188 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw

Date of submission: December 18th, 2009

1. Device Name:
  Proprietary Name: CLEVER CHOICE Mini Blood Glucose Monitoring System Regulatory Information:

Clinical Chemistry (75)

Regulation Section:21 CFR 862.1345 Glucose Test System A.
Class II B. Classification:
CGA, Glucose Oxidase, Glucose C. Product Code:
- NBW, System, Test, Blood Glucose, Over the Counter
Panel: D.

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1. Intended Use:
  This system is intended for use outside the body (in vitro diagnostic use only). It is used for the quantitative measurement of glucose in fresh capillary whole blood samples taken from the finger and the following sites: the palm, forearm, upper arm, calf and thigh. It is intended for use by people with diabetes mellitus at home and by health care professionals in clinical settings as an aid to monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not for use on neonates.

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

1. Device Description:
  The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only CLEVER CHOICE Mini test strips and CLEVER CHOICE control solutions with the CLEVER CHOICE Mini Blood Glucose Monitoring System.
1. Substantial Equivalence Information:
  Predicate device name: A. FORA G30 Blood Glucose Monitoring System

Predicate K number: K090187 B.

Comparison with predicate: C.

The modified CLEVER CHOICE Mini blood glucose monitoring system has the following similarities to the predicate device:

비 same operating principle,
same fundamental scientific technology, .
트 incorporate the same basic circuit design,
incorporate the same materials, 그
same shelf life
packaged using the same materials, and
manufactured by the same process. 1

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The modifications encompass:

A modification in the software of the glucose meter l
Modification in the physical appearance 1
Engineering modifications 1
Labeling change D

6. Test Principle:

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.

1. Performance Characteristics:
  CLEVER CHOICE Mini Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system performance demonstrated that the CLEVER CHOICE Mini blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the CLEVER CHOICE Mini blood glucose monitoring system is equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the CLEVER CHOICE Mini blood glucose monitoring system is substantially equivalent to the predicate FORA G30 Blood Glucose Monitoring System.

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.

TaiDoc Technology Corporation c/o Ms. Debra Liang Senior Specialist, Regulatory Affairs 6F, No. 127, Wugong 2nd Road, Wugu Township Taipei County, China (Taiwan) 248

MAR 2 3 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: K093941

Trade/Device Name: CLEVER CHOICE Mini Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: February 12, 2010 Received: February 23, 2010

Dear Ms. Liang:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Courtney C. Harper, 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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Section 8.

Indications for Use

K093941 510(k) Number:

Device Name: CLEVER CHOICE Mini Blood Glucose Monitoring System

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use _ X (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 Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(k) | 0

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8-1 of 1

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.