The U-RIGHT TD-4227 No Coding 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, and is not intended for use on neonates.

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

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Description

U-RIGHT TD-4227 No Coding 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

This 510(k) summary provides limited information regarding the acceptance criteria and study details for the U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System. The document states that the performance data of the U-RIGHT TD-4227 system can reference K072784 because "the change between the predicate and proposed devices is only in the brand name." This implies that the current submission (K090188) did not include new performance studies. Therefore, the following answers are based on the assumption that the predicate device (Clever Chek TD-4227 Blood Glucose Monitoring System, K072784) met the necessary criteria, and its performance data would be the basis for demonstrating equivalence. However, the provided document does not contain the actual performance data or study details for the predicate device, K072784.

Based on the provided text, a comprehensive answer for a new study is not possible. However, I can extract the available information and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K090188) for the U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System does not include a table of acceptance criteria or reported device performance. It explicitly states: "Since the change between the predicate and proposed devices is only in the brand name, the performance data of U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System can be reference to K072784."

To provide this table, one would need to refer to the 510(k) submission for the predicate device, K072784, which is not included in the provided text. Typically, for blood glucose meters, acceptance criteria would align with regulatory standards like ISO 15197, which specify accuracy requirements (e.g., within ±15% or ±20% for certain glucose ranges, or percentage of readings within specific zones of an error grid analysis).

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set or the data provenance for the U-RIGHT TD-4227 system, as it references the predicate device (K072784) for performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The provided document does not specify the number of experts or their qualifications for establishing ground truth, as it references the predicate device (K072784) for performance data.

4. Adjudication Method for the Test Set

The provided document does not specify an adjudication method for the test set, as it references the predicate device (K072784) for performance data.

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 question is not applicable to the U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System. This device is a blood glucose meter, an in-vitro diagnostic device that provides a quantitative measurement of glucose. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers and MRMC studies.

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

This question is not applicable in the context of "algorithm only" as typically understood for AI/ML devices. The device itself is a standalone system for measuring blood glucose from a physical sample. The performance study for such a device assesses its accuracy in measuring glucose compared to a reference method, not an algorithm's classification performance.

7. The Type of Ground Truth Used

Assuming studies for the predicate device (K072784) followed standard practices for blood glucose meters, the ground truth would have been established using a reference laboratory method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, hexokinase method) on the same blood samples tested by the device. This is a highly accurate chemical analysis, often considered equivalent to "pathology" or gold-standard laboratory results, rather than expert consensus or outcomes data in this context.

8. The Sample Size for the Training Set

The provided document does not specify the sample size for a training set. For a blood glucose meter, it's unlikely there's a "training set" in the machine learning sense. The device's calibration and algorithm are typically established during its development phase using a large number of samples, but this is usually referred to as calibration or development data rather than a "training set" for a distinct algorithm that undergoes continuous learning.

9. How the Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" in the machine learning context is generally not directly applicable to a traditional electrochemical blood glucose meter. The ground truth for developing and calibrating such a device would be established by comparing its readings to a reference laboratory method across a wide range of glucose concentrations during the design and engineering phases.

Summary of what is present and what is missing from the provided text:

Present: Device description, intended use, comparison to predicate, a statement that performance data references K072784 due to brand name change.
Missing from this document:
- Specific acceptance criteria.
- Detailed performance results (accuracy, precision, linearity).
- Sample size of the test set.
- Data provenance (country of origin, retrospective/prospective).
- Details on experts for ground truth.
- Adjudication method.
- MRMC study information.
- Standalone algorithm performance (as typically asked for AI/ML).
- Sample size for a training set.
- Method for establishing ground truth for a training set.

To obtain the specific details requested, one would need to access the 510(k) submission for the predicate device, K072784.

Summary

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JUL 1 3 2009

510 (k) Summary

Page 1-of-2

Submitter Information Company name Contact person Address

Phone FAX E-mail

Name of Device Trade Names

Common Names/Descriptions

Classification Names

Predicate Device Trade/Proprietary Name:

Common/Usual Name:

Manufacturer 510 (k) Number

TaiDoc Technology Corporation Erica Li 6F, No. 127, Wugong 2nd Rd, Wugu Township, Taipei County, 248, Taiwan (886-2) 6625-8188 (886-2) 6625-0288 erica@taidoc.com.tw

U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)

Clever Chek TD-4227 Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K072784

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4. Device Description

5. Intended Use

U-RIGHT TD-4227 No Coding 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 plam, 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 contains speaker function which provides step by step instructions.

6. Comparison to Predicate Device

U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System has equivalent technological characteristics as the Clever Chek TD-4227 blood alucose monitoring system (K072784). U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System also has the same intended use as the Clever Chek TD-4227 blood glucose monitoring system

7. Performance Studies

Since the change between the predicate and proposed devices is only in the brand name, the performance data of U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System can be reference to K072784.

8. Conclusion

U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.

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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 eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Taidoc Technology Corporation c/o Ms. Erica Li Management Representative 6F, No. 127, Wugong 2nd Road Wugu Township, Taipel County, China (Taiwan) 241

JUL 1 8 2009

Re: K090188

Trade Name: U-Right TD-4227 No Coding Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: May 21, 2009 Received: May 26, 2009

Dear Ms. Li:

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 ( frecting 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).

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H.

Courtney C. Harper, Ph.D. Acting 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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Attachment 3

Indications for Use

510(k) Number: K090188

Device Name: U-RIGHT TD-4227 No Coding 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 contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Over-The-Counter Use AND/OR X Prescription Use X (Part 21 CFR 801 Subpart D) (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)

Page 1 of

Carol C. Bensen
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 8 of 21

510(k) K0%188

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.