The EasyPlus mini R13N SMBG 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.

The EasyPlus mini R13N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Meter. 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.

The EasyPlus mini R13N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are 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.

EasyPlus mini R13N Glucose Control Solutions For the use with EasyPlus mini R13N meter and EasyPlus mini R13N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification from the FDA for a blood glucose monitoring system, the "EasyPlus mini R13N Self-Monitoring Blood Glucose System." It primarily addresses regulatory aspects, substantial equivalence, and indications for use.

Crucially, this document does not contain the detailed study results, acceptance criteria, or an analysis of device performance that would be required to answer your specific questions. It confirms the device's clearance based on substantial equivalence to existing devices but does not provide the underlying performance data from the validation studies.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a blood glucose monitoring system, not an AI-based imaging or diagnostic device involving human readers in that capacity. Therefore, an MRMC study as described would not be applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: While the device itself is a standalone measurement system, the details of its performance study as "algorithm only" are not provided.
The type of ground truth used: Not explicitly stated, though for a blood glucose monitor, ground truth would typically be established by a reference laboratory method.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

In summary, the provided FDA 510(k) letter is a regulatory clearance document. It does not include the technical details of the performance study that would show how the device meets specific acceptance criteria. To answer your questions, you would need to access the actual performance study report that was submitted to the FDA as part of the 510(k) application.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular pattern around the eagle.

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

AUG 1 8 2009

EPS Bio Technology Corp. c/o Y.C. Lei General Manager 2F No. 49-2, Lane 2, Sec. 2, Guang Fu Road Hsinchu City, 300 Taiwan, R.O.C.

Re: K091481

Trade Name: EasyPlus mini R13N Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA Dated: July 31, 2009 Received: August 4, 2009

Dear Mr. 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

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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 (OS) regulation (21 CFR Part 820).

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,

Sanith acting

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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Indications for Use Form

510(k) Number (if known): K091481 Device Name: EasyPlus mini R13N SMBG system Indications for Use:

EasyPlus mini R13N SMBG Test System

EasyPlus mini R13N Meter

EasyPlus mini R13N Blood Glucose Test Strips

EasyPlus mini R13N Glucose Control Solutions

For the use with EasyPlus mini R13N meter and EasyPlus mini R13N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091481

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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.