The Prodigy® Diabetes Management Software is indicated for use as a data management tool for the acceptance, transfer, display, storage, processing (e.g., averaging). Reporting, and printing of patient blood glucose monitoring data.
The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.

Device Description

The Prodigy® Diabetes Management Software is a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level. The software allows for an accident member of their blood Glucose Monitor via a USB cable. The Prodigy® Diabetes Management Software is designed to operate on the patient's PC with Microsoft SQL Server 2005 or later operating system. Prodigy® Diabetes Care LLC website will provide a link to download the Microsoft SQL Server 2005 Server 2005.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Prodigy® Diabetes Management Software, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided document, primarily a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative or qualitative "acceptance criteria" and then directly reporting performance against them in the traditional sense of a clinical trial. Instead, the "acceptance criteria" are implied by the features and functionalities deemed necessary to be equivalent to the predicate device. The "reported device performance" is largely qualitative, indicating that these functionalities are present and work.

Parameter (Implied Acceptance Criteria)	Prodigy Diabetes Management Software Performance (Reported as Present/Functional)
Download blood glucose meter readings via USB interface cable	Yes
Electronic Log Book	Yes
Create User Profile	Yes
Create reports	(Implied by existing report/trending functionality)
Create trending graphs	Yes
Option for printing reports	Yes
Set Target - target blood glucose range	Yes
Average reading for each meal over the past several	Yes
Patient can create personal and meter profiles	Yes (Stated in Substantial Equivalence summary)
Patient can import data from the Prodigy Blood Glucose Meter	Yes (Stated in Substantial Equivalence summary)
Patient can set blood glucose target ranges and personal schedule	Yes (Stated in Substantial Equivalence summary)
Patient has a Log book to view recorded data	Yes (Stated in Substantial Equivalence summary)
Patient can retrieve reports and trending graphs	Yes (Stated in Substantial Equivalence summary)
Patient can print Trend graphs and reports	Yes (Stated in Substantial Equivalence summary)
Ease of use	Verified (by clinical usability study)
Label comprehension	Verified (by clinical usability study)

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

The document mentions a "clinical usability study" or "Human Factor Study" but does not specify the sample size used for the test set.

The data provenance is not specified (e.g., country of origin). It can be inferred that the study was prospective, as it was conducted "to verify ease of use and label comprehension" for the device being submitted.

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

The document does not specify the number of experts or their qualifications, nor does it explicitly mention "ground truth" in the context of expert review for the usability study. The usability study would typically involve end-users, not necessarily experts for ground truth establishment.

4. Adjudication Method for the Test Set

The document does not provide any information regarding an adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance data section only mentions a "clinical usability study" or "Human Factor Study" to verify ease of use and label comprehension. This type of study is not an MRMC comparative effectiveness study, and there is no mention of comparing human readers with and without AI assistance, nor any effect size.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is described as "software management system" and "data management tool" for blood glucose monitoring data. Its primary function is displaying, storing, processing, reporting, and printing data from a blood glucose meter. It is not an AI algorithm performing diagnostic tasks in a standalone manner where performance metrics like sensitivity/specificity for a diagnosis would be relevant. The "performance data" refers to a usability study, not a standalone algorithmic performance test. Therefore, a standalone algorithmic performance study in the typical sense for an AI diagnostic device was not conducted or is not applicable to this type of device.

7. The Type of Ground Truth Used

For the "clinical usability study," the "ground truth" would implicitly be the successful and intuitive completion of tasks by the study participants and their feedback on ease of use and comprehension, as measured against predefined usability criteria. It's not a "ground truth" derived from expert consensus, pathology, or outcomes data, as those are typically associated with diagnostic or image analysis devices.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is a data management software, not a machine learning or AI model that requires a "training set" in the conventional sense.

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

Since there is no mention of a training set for an AI/ML model, there is no information on how ground truth for a training set was established.

Summary

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K103115

OCT 1 2 2011

510(k) Summary 807.92(c)

SPONSOR

Company Name:

Prodigy Diabetes LLC

807.92(a)(1)

Company Address:

9300 Harris Corners Parkway Suite 450 Charlotte, NC 28269

Telephone: Fax: Contact Person:

704-285-6400 Fax: 704-285-6475 Rick Admani

Summary Preparation Date: October 14, 2010

DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Panel:

807.92(a)(2) Prodigy® Diabetes Management Software Blood Glucose Meter and Data Management System, Test, Blood Glucose, Over the Counter 862.1345 NBW:JOP II Clinical Chemistry

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device Company Product Becton Dickinson BD™ Diabetes Software

DEVICE DESCRIPTION

807.92(a)(4)

510(k) #

K023219

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DEVICE INTENDED USE

807.92(a)(5)

The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.

Parameters	Prodigy DiabetesManagement Software	Becton Dickinson DiabetesSoftware
510(k) Number:		K023219
Indications for Use	The Prodigy® DiabetesManagement Software isindicated for use as a datamanagement tool for theacceptance, transfer,display, storage, processing(e.g., averaging). Reporting,and printing of patientblood glucose monitoringdata.The Prodigy® DiabetesManagement Software isindicated for use with theProdigy Blood GlucoseMonitoring Systems only.	The BD™ DiabetesSoftware is intended for useas a data management toolfor acceptance, transfer,display, storage, processing(e.g. averaging), reporting,and printing for patientblood glucose monitoringdata.The device is intended foruse with the BD BloodGlucose MonitoringSystems only.
Download blood glucosemeter readings via USBinterface cable	Yes	Yes
Electronic Log Book	Yes	Yes
Create User Profile	Yes	Yes
Create reports
Create trending graphs	Yes	Yes
Option for printingreports	Yes	Yes
Features of the SoftwareSystem
Set Target - target bloodglucose range	Yes	Yes
Average reading for eachmeal over the past several	Yes	Yes

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

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SUBSTATIAL EQUIVALENCE

The software feature comparisons above of the BD™ Diabetes Software and the Prodigy® Diabetes Management Software demonstrate that the Prodigy® software system is substantially equivalent to the predicate device based on the following similarities:

Patient can create personal and meter profiles .
Patient can import data from the Prodigy Blood Glucose Meter, .
Patient can set blood glucose target ranges and personal schedule, .
Patient has a Log book to view recorded data, .
Patient can retrieve reports and trending graphs, and .
. Patient can print Trend graphs and reports

PERFORMANCE DATA

A clinical usability study was performed to verify ease of use and label comprehension.

CONCLUSION

807.92(b)(3)

Based on the product comparison and the Human Factor Study Prodigy® Diabetes Care LLC concludes that the Prodigy® Diabetes Management Software does not raise any new issues concerning safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/13 description: The image shows a logo with a circular border containing text, though the text is too blurry to read. Inside the circle is a stylized bird-like figure with three curved lines representing its wings or feathers. The logo appears to be a symbol for an organization or service, possibly related to health or nature.

Public Health Service

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

Prodigy Diabetes Care, LLC. c/o Smith Associates E.J. Smith, Consultant 1468 Harwell Avenue, Crofton. MD 21114

OCT 1 2 2011

Re: K103115

Trade/Device Name: Prodigy Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name:Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: September 28, 2011 Received: September 28, 2011

Dear Mr. Smith:

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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Page 2 -

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 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,

signature

Courtney H. Lias, 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

103115

510(k) Number (if known):

Device Name: Prodigy® Diabetes Management Software

Indications for Use:

The Prodigy® Diabetes Management Software is intended for use as a data management tool for acceptance, transfer, display, storage, processing (e.g. averaging), reporting and printing of patient blood glucose monitoring data.

The device is intended for use with the Prodigy® Blood Glucose Monitoring Systems only.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 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)

Que

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k). 103115

Page 1 of

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.