The EasyMax V Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

The EasyMax V Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by heatthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

The EasyMax V Blood Glucose Test Strips is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

EasyMax V Glucose Control Solutions: For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

EasyMax V Glucose Control Solutions: For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and study details for the EasyMax V SMBG System:

The provided text is an FDA 510(k) clearance letter and its associated "Indications for Use" statement. It formally states that the device has been cleared for market based on substantial equivalence to a predicate device. However, this document does not contain a detailed study report or specific acceptance criteria and performance data for the EasyMax V SMBG System itself.

The FDA clearance letter signifies that the device has met regulatory requirements, which would inherently involve studies demonstrating performance. However, the details of those studies, including specific acceptance criteria, reported performance, sample sizes, ground truth establishment methods, and expert qualifications, are not present in this document. Such information is typically found in the full 510(k) submission, which is not provided here.

Therefore, I cannot directly populate the requested table and answer many of the questions based solely on the provided text. I can only infer general information about the device's intended use and regulatory status.

Inferences based on the provided text:

Device Type: Self-Monitoring Blood Glucose (SMBG) System.
Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples (fingertips or forearm). Aid to monitor the effectiveness of diabetes control.
Users: Persons with diabetes (at home / OTC) or healthcare professionals (clinical settings).
Exclusions: Not for diagnosis or screening of diabetes, not for visually impaired users or neonates.
Regulatory Class: Class II.

Attempt to answer based on the lack of information in the provided text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided document. For SMBG systems, regulatory bodies typically look for agreement with a lab reference method (e.g., ISO 15197 standards for accuracy, precision under various conditions).
- Reported Device Performance: Not specified in the provided document. Performance metrics would typically include accuracy (e.g., % within ±15 mg/dL or ±15% of reference), precision (CV%), and various interference studies.
Sample size used for the test set and the data provenance: Not specified in the provided document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.
Adjudication method for the test set: Not specified in the provided document.
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: Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool that would involve "human readers" in that context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Self Monitoring Blood Glucose Test System," implying direct measurement by the system without a complex "algorithm only" component separate from the integrated device function. However, the specific details of its standalone performance (e.g., how its readings compared to a gold standard) are not in this document.
The type of ground truth used: Not specified in the provided document. For blood glucose monitors, the ground truth is typically a laboratory reference method (e.g., YSI glucose analyzer).
The sample size for the training set: Not specified in the provided document.
How the ground truth for the training set was established: Not specified in the provided document. (If a "training set" in the machine learning sense was even used, which is unlikely for a device of this type).

Conclusion:

The provided FDA 510(k) clearance letter and Indications for Use document confirm the regulatory clearance of the EasyMax V SMBG System but do not contain the detailed study information, acceptance criteria, or performance data that would answer most of your questions. Such information resides in the full 510(k) submission document, which is not available in the given text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three curved lines representing its body and wings. The logo is in black and white.

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

EPS Bio Technology Corporation c/o Mr. Y.C. Lei General Manager 2F, No. 49-2, Lane 2, Sec. 2, Guang Fu Road Hsinchu City, China (Taiwan) 30071

FEB 2 L 2010

Re: K092894

Trade/Device Name: EasyMax V SMBG System Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: January 21, 2010 Received: January 25, 2010

Dear Mr. Y.C. Lei:

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); medical device 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/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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Indications for Use

510(k) Number (if known): K092894

Device Name: EasyMax V SMBG system

Indications for Use:

EasyMax V SMBG Test System

EasyMax V Meter

EasyMax V Blood Glucose Test Strips

EasyMax V Glucose Control Solutions

For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use V (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)

Livesion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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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.