The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

The Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

Device Description

The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) blood glucose meters, b) blood glucose plus blood pressure monitors, and c) blood pressure monitors. When use with one of these devices, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Health Care System Software (K110948), based on the provided text:

Important Note: The provided 510(k) summary (K110948) focuses on demonstrating substantial equivalence rather than detailed performance studies with specific statistical metrics typical for AI-powered diagnostic devices. The device is a data management software, not a diagnostic AI. Therefore, many standard AI/ML acceptance criteria (e.g., sensitivity, specificity, AUROC) and the sophisticated study designs to prove them are not applicable or detailed in this document. The "performance studies" mentioned are primarily about software and hardware validation to ensure data transfer integrity and functionality.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	Have the same intended use and intended users as the predicate device.	The device "has the same intended use and intended users" as the predicate.
Data Presentation	Have the same data presentation as the predicate device.	The device "has the same data presentation" as the predicate.
Programming Language	Utilize the same programming language as the predicate device.	The device "has same programming language" as the predicate.
Data Integrity	Data transferred from the device cannot be changed or modified in any way.	"data transferred from the device cannot be changed or modified in any way."
Added Features Functionality	The added features (temperature data tabular display, graph display, printer setting) function as intended.	Not explicitly detailed with specific metrics, but "Results demonstrate that the system meets its intended use." Implies these features work.
Hardware Validation	Successful data transfer through the cable.	"validation of hardware (data transfer through the cable)" was performed and met intended use.
Software Validation	Software functions as intended for data management, review, analysis, and evaluation.	"software validation" was performed and met intended use.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Testing of Health Care System Software included validation of hardware (data transfer through the cable) and software validation." No specific number of data points, transfers, or users are mentioned for the test set.
- Data Provenance: Not specified. It's unclear if the testing involved real-world patient data or simulated data, where it originated (e.g., country), or if it was retrospective or prospective. Given the nature of a software accessory for data management, it likely involved simulated or controlled data transfer scenarios rather than clinical patient data analysis for diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified. This device is a data management software accessory, not an AI diagnostic tool that requires expert-established ground truth for medical conditions. The "ground truth" here would relate to the correctness of data transfer and display, which is typically validated through engineering and software testing.
- Qualifications of Experts: Not applicable/Not specified.
Adjudication method for the test set:
- Adjudication Method: Not applicable/Not specified. As it's software validation for data management rather than diagnostic interpretation, multi-reader adjudication methods are not relevant.
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: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. The device is a data management software, not an AI designed to assist human readers in making diagnostic decisions. Its purpose is to facilitate review and analysis of historical test results, not to interpret them or improve diagnostic accuracy directly.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, in a sense, the "Performance Studies" section describes validation of the software and hardware working independently to transfer and manage data. The device's primary function is its standalone capability to capture and organize data from connected meters. It does not perform diagnostic tasks that would typically involve "human-in-the-loop" interaction in the context of AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For this type of device, the "ground truth" would be established by the expected behavior of the software and hardware according to its specifications. This means:
  - Correct Data Transfer: Verification that data points (e.g., blood glucose readings, blood pressure) are transferred accurately and completely from the meter to the computer.
  - Correct Data Display: Verification that the transferred data is displayed correctly (e.g., tabular format, graph format for temperature) as per the software design.
  - Data Integrity: Confirmation that transferred data remains unmodified.
  - This is typically validated through software testing and quality assurance protocols comparing actual output against expected output based on source data. It does not involve medical ground truths like pathology reports or expert consensus on a diagnosis.
The sample size for the training set:
- Sample Size: Not applicable/Not specified. This device is a traditional software application for data management, not a machine learning or AI model that requires a "training set" in the conventional sense. The software is developed based on programming logic and specifications, not trained on data.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for a training set.

Summary

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K110948

8. 510 (k) Summary

MAY 1 3 2011

Submitter Information Company name . Contact person Teling Hsu Address Phone

FAX E-mail Date Prepared

Name of Device Trade Names Product code Classification Names and Regulations

TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Rd. Wuqu Township, Taipei County 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw March 30th, 2011

Health Care System Software NBW; DXN; FLL

a) Calculator/data processing module for clinical use, Class I, 21 CFR 862.2100 b) Glucose Test System, Class II, 21 CFR 862.1345 c) Noninvasive Blood Pressure Measurement System, Class II, 21 CFR 870.1130, d) General Hospital, Class II, 21 CFR 880.2910

Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number

Clever Chek Health Care System Software Data management software TaiDoc Technology Corporation K070941

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4. Device Description

5. Intended Use

6. Comparison to Predicate Device

The Health Care System Software is substantially equivalent to the Clever Chek Health Care System Software (K070941). Both management software programs can be described as follows:

have the same intended use and intended users
have the same data presentation
have same programming language
data transferred from the device cannot be changed or modified in any way.

The modifications include:

-Added temperature data tabular display setting
-Added temperature graph display setting
-Added temperature data printer setting

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7. Performance Studies

Testing of Health Care System Software included validation of hardware (data transfer through the cable) and software validation. Results demonstrate that the system meets its intended use.

8. Conclusion

Health Care System Software is substantially equivalent to the predicate device.

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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 eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 3 2011

Mr. Teling Hsu Regulatory Affairs Specialist TaiDoc Technology Corporation 6F, No, 127, Wugong 2nd Road Wugu Township Taipei County Taiwan 24888

Re: K110948

Trade/Device Name: Health Care System Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, DXN, FLL Dated: May, 4, 2011 Received: May 6, 2011

Dear Mr. Hsu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K110948

Device Name: Health Care System Software

Indications for Use:

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

Rhit C. Aly 5/12/16
Division Sign-Off

Division Sign-Off Office of In Vitro Diagnostic Device

Evaluation and Safety
510(k) K110948

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.