The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meters for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Device Description

The On Call® Plus Diabetes Monitoring Software is for downloading glucose data from the On Call Plus meter to a PC through an USB to RS232 TTL level cable or RS232 to RS232 TTL level cable, with tracking and trending capabilities of glucose measurements.

The Diabetes Data Management Software is intended to be used in a clinical setting with multiple patients by a healthcare professional, or directly by the patient.

The user has the choice to install either a personal "Home" or "Professional" version. In the "Home" version, glucose results are assembled for a single user. In the "Professional" version, the software user can configure a database with multiple providers and patients. The number of providers, patients and data points is limited only by the computer's capabilities.

AI/ML Overview

The provided text outlines the capabilities of the "On Call® Plus Diabetes Monitoring Software" and compares it to a predicate device, focusing on its functional characteristics rather than specific quantitative performance metrics against acceptance criteria in the typical sense of a diagnostic or therapeutic medical device.

Therefore, the table of acceptance criteria and reported device performance, and several other requested items, cannot be fully populated as they would for a device with measurable accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" here relate to the software's ability to perform its intended functions and demonstrate substantial equivalence to a predicate device for regulatory approval.

Here's an attempt to answer your questions based on the provided text, acknowledging the limitations due to the nature of the device (diabetes monitoring software, not a diagnostic test):

1. Table of Acceptance Criteria and the Reported Device Performance

For this software, the "acceptance criteria" appear to be related to its functional conformity to its intended use and its substantial equivalence to the predicate device. The document does not specify quantitative performance metrics (e.g., accuracy, precision) as would be found for a glucose meter itself, but rather functional capabilities of the software.

Acceptance Criteria (Implied from Summary)	Reported Device Performance (as stated in the document)
Software Functionality:
- Ability to download glucose data	- Software successfully downloads glucose data from On Call Plus meter to a PC.
- Tracking and trending capabilities	- Provides tracking and trending capabilities of glucose measurements through tables and graphs (data list report, line, bar, pie charts, average day line chart, average day/week bar charts).
- Support for multiple users/patients	- "Professional" version allows configuration of a database with multiple providers and patients, limited only by computer capabilities.
- Data representation (units)	- Supports millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL).
- Password protection	- Supports password protection for databases.
- Data management (delete)	- Can delete patients, providers, databases, and data stored in meters.
Usability/User Experience (Clinical Test):
- Ease of operation by intended users	- "Study results indicate that non-professional, inexperienced lay persons were able to operate the software and obtain glucose trending reports." - "Participating lay persons were questioned and responded as satisfied with the ease of operation by following the User's Manual and the overall performance of the On Call® Plus Diabetes Monitoring Software."
Regulatory/Safety Compliance:
- Compliance with software guidance	- Evaluated by performing software validation tests; compliance with "Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff."
- Compliance with voluntary standards	- Compliance to EN 62366:2008 for usability engineering and EN 62304:2006 for software life cycle processes.
- Substantial Equivalence	- "The laboratory testing and clinical study results demonstrate that the On Call® Plus Diabetes Monitoring Software is safe, effective and easy-to-use. It demonstrates that the On Call® Plus Diabetes Monitoring Software meets all the validation and clinical requirements and is substantially equivalent to the Bayer Glucofacts Deluxe Diabetes Management Software."

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

Test Set Sample Size: The document states that "Clinical studies were conducted with lay persons," but does not specify the exact number of lay persons who participated in this usability test.
Data Provenance: Not explicitly stated, but the submission is to the FDA from a company (ACON Laboratories, Inc.) based in San Diego, California, USA. The "clinical studies" for usability were likely conducted within the U.S. and are prospective in nature, as they involve users interacting with the device for evaluation.

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

This information is not applicable or not provided in the context of this software. The "clinical study" described is a usability study where lay persons evaluate the software's ease of operation. There isn't a "ground truth" to be established by experts in the typical clinical sense (e.g., diagnosis of a condition). The "truth" being evaluated is whether lay users can successfully operate the software.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since the primary evaluation was a usability study with lay persons, there's no mention of an adjudication process by experts to resolve disagreements on a 'ground truth' diagnosis or outcome. The evaluation seems to be based on the users' ability to perform tasks and their satisfaction.

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 is not applicable. The device is monitoring software for diabetes glucose data, not an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists, pathologists) in making diagnoses. Therefore, an MRMC study comparing human performance with and without AI assistance is not relevant to this device.

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

This is not applicable in the traditional sense of a diagnostic algorithm. The "On Call® Plus Diabetes Monitoring Software" is an accessory for a glucose meter. Its function is to transfer, organize, and display data collected by the meter, not to autonomously interpret or diagnose without human interaction. The "software validation test" and "clinical study" confirm its functional performance and usability.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

As this is a diabetes monitoring software solely for data management and visualization, there is no "ground truth" in the diagnostic sense (like pathology or expert consensus on a disease). The "truth" validated by the software is:

Its ability to accurately transfer glucose readings.
Its ability to correctly organize and display this data in various reports and charts according to its specifications.
Its ease of use by its intended users.

The non-clinical tests focused on software validation (ensuring it performs as designed) and compliance with relevant software standards. The clinical test focused on usability by lay persons.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the typical machine learning sense for this device. The software appears to be rule-based for data management and visualization, rather than an AI/ML model that requires a "training set" of data to learn from. The software's development would involve standard software engineering practices and testing, not AI model training.

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

This information is not provided and is likely not applicable, as explained in point 8.

Summary

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ડ. 510(k) Summary

The summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

Submitters Identification:

ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121

Tel: 858-875-8019 Fax: 858-875-8099

Date prepared: May 7th, 2010

Contact Person:

Richard Lenart Regulatory Affairs Manager

Proprietary Name of the Device:

On Call® Plus Diabetes Monitoring Software

Common name:

Diabetes Software

Classification Name:

Class I §862.2100 Calculator/data processing module for clinical use. Class II §862.1345 Glucose Test System (To be manufactured and marketed for consumer home and professional use)

Predicate Device:

Glucofacts® Deluxe Diabetes Management Systems Bayer Healthcare 430 South Beiger Street, Mishawaka, IN 46544 510(k) K091820

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Device name: On Call® Plus Diabetes Monitoring Software

Proprietary Name	Classification	ProductCode	Description	Common Name
On Call® PlusDiabetesMonitoringSoftware	§862.1345§862.2100	NBW,JQP	System, Test,Blood Glucose,Over The Counter	DiabetesSoftware

Description:

The Diabetes Data Management Software is intended to be used in a clinical setting with multiple patients by a healthcare professional, or directly by the patient.

Intended Use:

Technological Characteristics:

Feature	Specification
System Requirements	Pentium or equivalent processor, USB or RS-232 9-pin serial port128 MB memory, 70 MB hard drive space, minimum 800 x 600display, CD-ROM drive
Operating Systems	Microsoft Windows 2000, XP Home/Professional, Vista, windows 7
Reports, Charts and Graphs	Data list report, line, bar and pie charts, average day line chart,average day/week bar charts.
Glucose Units of Measure	millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL)
Users	Multiple users and patients limited only by the capabilities of thecomputer being used
Passwords	Create databases that are password protected

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Delete Memory	comparent proposes and proposations and proposes and charges of confessional con- Can delete patients, providers, databases and data stored in meters
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Comparison to Predicate Device:
The On Call® Plus Diabetes monitoring Software is substantially equivalent to
Glucofacts® Deluxe Diabetes Management Softwa

Features	On Call® Plus Diabetes MonitoringSoftware	Glucofacts® Deluxe DiabetesManagement Software(K091820)
Similarities
COM Ports scan	Automatic scan for connected ports	Same
Multiple patients	Can list data for multiple patients	Same
Data list/ Summaryreport	List of all readings inside selectedtime frame	Same
Reports and charts	Data List, Log Book report, StandardDay report, Trend report, Pie charts	Same
Target levels	High, low, hyper and hypo glucosetarget levels can be changed	Same
Time periods	Daily time periods can be changed	Same
Units of measure	Can choose either mmol/L or mg/dL	Same
Data Base	Can Set up multiple patient data bases	Same

Differences
Change Metersettings	Does not allow change to metersettings through the DiabetesMonitoring Software	Allows target range, alarm soundsand optional level changes tosupported meters through theManagement Software
Operating System	Microsoft Windows 2000, XPHome/Professional, Vista, windows 7	Microsoft Windows XP, Vista orMac OS 10.5.7 or later (Mac is onlyan option with the Contour USBmeter)
Associate a meter toa person	No association	Software can be set to recognizemeters and associate them tospecific patients
Standard weekreport	No Standard Week report	A graph that displays all readingsby day overlapping all the days ona one week graph
Average Week	A bar graph that averages allreadings for each day by day of theweek, Sunday through Saturday andbefore and after meals.	No average week report
Average Day	A bar graph that averages all readingsfor each day by time slot and beforeand after meals.	No average day report
Password	Allows providers accounts to bepassword protected	Does not have password protectionon the software
Providers	Allows for multiple providers eachwith their own data base of patients	Does not have providers but doesallow for multiple databases

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Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: '

The performance characteristics of the On Call® Plus Diabetes Monitoring Software were evaluated by performing the software validation test. Guidance documents included "Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff." Compliance to applicable voluntary standards includes EN 62366:2008, "Medical devices, Application of usability engineering to medical devices" and EN 62304:2006 "Medical device software, Software life cycle processes."

Discussion of Clinical Tests Performed:

Clinical studies were conducted with lay persons using the On Call® Plus Diabetes Monitoring Software to demonstrate that the intended user can easily operate the software features including Installing the software, transferring meter data to the computer, changing settings, setting up providers and patients, using passwords, viewing and printing reports and uninstalling the software.

Study results indicate that non-professional, inexperienced lay persons were able to operate the software and obtain glucose trending reports. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the User's Manual and the overall performance of the On Call® Plus Diabetes Monitoring Software.

Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call® Plus Diabetes Monitoring Software is safe, effective and easy-to-use. It demonstrates that the On Call® Plus Diabetes Monitoring Software meets all the validation and clinical requirements and is substantially equivalent to the Baver Glucofacts Deluxe Diabetes Management Software sold on the U.S. market (K091820).

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Image /page/4/Picture/0 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 wing-like shapes, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circle's perimeter.

Acon Laboratories, Inc. c/o Richard Lenart 10125 Mesa Rim Rd., San Diego, CA 92121

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

JAN 07 2011

Re: K101371

Trade/Device Name: On Call Plus Diabetes Monitoring Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW. JOP Dated: December 3, 2010 Received: December, 6, 2010

Dear: Mr. Lenart:

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 (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 Biometrio'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 vours.

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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4. INDICATIONS FOR USE

510(k) number (if known): K101371

JAN - 7 2011

Device Name: On Call® Plus Diabetes Monitoring Software

Indications for Use:

The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Prescription Use (Part 21 CFR 801 Subpart D) C) .

AND/OR

Over-The-Counter Use_ X (21 CFR 807 Subpart

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety Page I of _ l _ _ l

510(k) K10137

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.