By evaluating current and cumulative blood glucose levels, the EndoTool Glucose Management Sysstem (EGMS) - a glycemic management software support program is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician- determined target range.

The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more.

The EGMS logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.

Device Description

The EGMS includes: security features, software upgrades, data backup capabilities, and technical support. Each user has an individual User ldentification (ID) and Password in order to access portions of the application. Software upgrades are accessible through the EndoTool Portal website and the technical support is made easier by the use of Microsoft .Net technologies. EndoTool is designed to safeguard the confidentiality, integrity, and availability of electronic protected health information of patients according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rules. EndoTool is packaged in a user friendly, stand-alone program using Microsoft .Net technologies. The application requires Windows XP or Windows 7. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets them beyond a general statement that "Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended." Therefore, I cannot fully complete the requested table or answer all questions.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Specific performance metrics (e.g., accuracy, safety thresholds) are not provided in the document.	"Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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

A MRMC comparative effectiveness study is not explicitly mentioned. The document states "Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended," but does not detail the study design to determine if it was an MRMC study or if it measured improvement with AI assistance.

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

The document implies human-in-the-loop performance as it states, "The EGMS logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program." This suggests it is not a standalone algorithm without human intervention, but the specifics of a standalone performance study are not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified.

8. The sample size for the training set

Not specified.

9. How the ground truth for the training set was established

Not specified.

Summary of available information:

The provided 510(k) summary for the EndoTool Glucose Management System (K132547) presents a high-level overview. It mentions "Clinical user validation studies" that "demonstrated that the EGMS performs safely and effectively, as intended." However, it does not provide any specific details regarding:

Quantitative acceptance criteria (e.g., specific accuracy, precision, or safety metrics).
The methodology or results of these studies.
Sample sizes for training or testing sets.
The provenance or characteristics of the data used.
How ground truth was established.
Details about expert involvement or adjudication.
Whether MRMC or standalone performance studies were conducted.

The document primarily focuses on regulatory compliance (IEC 62304, ISO 14971) and substantial equivalence to predicate devices, rather than detailed performance study results.

Summary

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K132547 510(k) SUMMARY

Monarch Medical Technologies EndoTool Glucose Management System

Date Prepared: April 4, 2014

Submitter Information

Monarch Medical Technologies 2815 Coliseum Centre Drive, Suite 250 Charlotte, NC 28217-1361 Telephone: 704-335-1300 Fax: 704-335-1300 Website: www.monarchmedtech.com

Contact Information

Wilson P. Constantine 2815 Coliseum Centre Drive, Suite 250 Charlotte, NC 28217-1361 Phone: 704-323-4055 Facsimile: 704-323-4055 Wilson.Constantine@monarchmedtech.com

Proprietary Name: EndoTool Glucose Management System

Common or Usual Name: Drug Dose Calculator

Classification Name: Predictive pulmonary-function value calculator

Device Classification: Class II

Regulation Number: 21 CFR 868.1890

Product Code: NDC

Predicate Devices:

K113853 - Glytec LLC, G+ System K053137 - MD Scientific Inc., EndoTool Drug Dose Calculator

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Indications for Use:

The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more.

The EGMS logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.

Technological Characteristics:

Performance Data

The EGMS conforms to IEC 62304 Medical Device Software - Software LifeCycle Processes, 2006-05 and ISO 14971 Medical Devices - Risk Management -Application of Risk Management to Medical Devices, 2007-03-01. Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended.

Substantial Equivalence

The EGMS is as safe and effective as the EndoTool Drug Dose Calculator and the Glytec G+ System. The EGMS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the EGMS and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the EGMS is as safe and effective as the predicate devices, therefore EGMS is substantially equivalent.

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

April 17, 2014

Monarch Medical Technologies Mr. Wilson P. Constantine President, CEO 2815 Coliseum Centre Drive, Suite 250 Charlotte, NC 28217

Re: K132547

Trade/Device Name: EndoTool Glucose Management System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: April 9, 2014 Received: April 9, 2014

Dear Mr. Constantine:

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. Iisting 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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.

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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known) K132547

Device Name

EndoTool Glucose Management System, version 8.0 [EGMSv8.0]

Indications for Use (Describe)

The EndoToo! Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more.

The EGMS logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR THE LE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2014.04.17 14:19:00 -04'00'

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Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).