The Glucommander System is a glycemic management tool intended to evaluate current as well as cumulative patient blood glucose values coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable physician-determined target range.

The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.

The G+ System logic is not a substitute for, but rather an adjunct to clinical reasoning. The measurements and calculations generated are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended quidance provided by this software program.

The indications for use are identical to the predicate device.

Device Description

The Glucommander System is a software algorithm device intended to evaluate the current as well as cumulative patient blood glucose values and, based on the aggregate of those measurements, whether one or many, recommend a dosage of insulin, glucose, or saline in order to direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of insulin for both pediatric (ages 2-17 years) and adult patients.

AI/ML Overview

This document is a 510(k) summary for the Glytec Glucommander device. It details the device's description, indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device "Glytec Glucommander" functions as a software algorithm that recommends insulin, glucose, or saline dosages based on patient blood glucose values and other patient information. The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve the type of study that would typically establish quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, or dose accuracy compared to a ground truth) and then empirically prove the device meets those criteria through a structured test set evaluation, as is common for AI/ML-based diagnostic devices.

Instead, the submission for Glytec Glucommander focuses on demonstrating that new functionalities (Continuous Tube Feeding Module, Ambulatory Care Module, Subcutaneous Module) "do not raise different questions of safety or effectiveness" compared to the predicate device. The performance data section explicitly states: "The 510k submission included software, cybersecurity, and human factors documentation to demonstrate the performance of the device is substantially equivalent to the predicate."

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the way typically seen for standalone performance claims (e.g., accuracy against a medical ground truth). The acceptance criteria, in this context, relate more to regulatory and engineering standards (e.g., software validation, cybersecurity, human factors) and the demonstration of substantial equivalence rather than a medical performance metric.

Given the information provided, here's an analysis of what can be inferred or explicitly stated regarding the acceptance criteria and the "study" that proves the device meets them:

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

As explained above, the document does not present quantitative performance acceptance criteria (e.g., a specific percentage of cases where the device must be accurate in its recommendations) compared to a medical ground truth. Instead, the "acceptance criteria" are implied by the regulatory standard of "substantial equivalence" and the types of documentation provided.

Acceptance Criterion (Implied)	Reported Device Performance/Evidence
New functionality does not raise different safety/effectiveness questions. (Regulatory/Clinical)	"These features do not raise different questions of safety or effectiveness." Supported by non-clinical performance data comparing to the predicate.
Device is substantially equivalent to predicate device (K113853). (Regulatory)	"Information presented supports substantial equivalence of the Glucommander System to the predicate device." "The proposed enhancements have the same indications for use, are similar in design, have the same fundamental scientific technology, and are tested the same way as the predicate device."
Software functionality and integrity. (Engineering/Software)	"The 510k submission included software... documentation to demonstrate the performance of the device is substantially equivalent to the predicate." Implies compliance with software development lifecycle standards and verification/validation.
Cybersecurity. (Engineering/Security)	"...cybersecurity... documentation to demonstrate the performance of the device is substantially equivalent to the predicate." Implies measures to protect data and system integrity.
Human factors. (Usability/Safety)	"...human factors documentation to demonstrate the performance of the device is substantially equivalent to the predicate." Implies usability testing and design to minimize user error.
Compliance with general controls. (Regulatory)	Stated in the FDA letter: "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... good manufacturing practice... etc."

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

The document explicitly states that "Non-clinical performance data was used to demonstrate that the device is substantially equivalent to the predicate device." This suggests that the "testing" involved software, cybersecurity, and human factors validation rather than a clinical study with a patient data test set. Therefore, there is no stated sample size for a patient-based test set, nor information on data provenance (country, retrospective/prospective). This submission relies on engineering and software validation and comparison to a predicate, not clinical performance data from a patient cohort.

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)

Given that "Non-clinical performance data" was used and no clinical test set for algorithmic performance against a medical ground truth is described, there is no information provided regarding experts establishing ground truth for a clinical test set.

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

Not applicable, as no clinical test set with human adjudication is described.

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

No such study is mentioned or implied. The device is a "drug dose calculator" that recommends dosages, and is an "adjunct to clinical reasoning," not typically a diagnostic AI. The submission focuses on substantial equivalence through non-clinical data.

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

The "performance data" provided are non-clinical (software, cybersecurity, human factors). The device provides "recommendations," implying human-in-the-loop operation, but no standalone performance data for the algorithm's medical accuracy (e.g., how often its recommendations are correct/optimal compared to a gold standard) is detailed for a specific test set. The claim relies on the new modules being "similar in design" and "tested the same way as the predicate device," which itself would have had to meet performance criteria.

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

Not applicable, as no clinical test set requiring a medical ground truth (e.g., for diagnostic accuracy or treatment efficacy) is described in this 510(k) summary. The ground truth, implicitly, would be the established performance and safety of the predicate device, against which the new functionalities are compared through non-clinical means.

8. The sample size for the training set

The document does not describe the development or training of an AI/ML model in a manner that would typically involve a "training set" of patient data. The Glucommander is described as a "software algorithm device," which could imply rule-based logic or a different type of computational model not necessarily relying on a large data training set in the way modern deep learning AI does. Therefore, there is no information on a training set sample size.

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

Not applicable, as no training set is described. If the algorithm is rule-based, its "ground truth" would be established by clinical guidelines and expert medical knowledge encoded into the software rather than data-driven training.

Summary

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Glytec®

5. TRADITIONAL 510(K) SUMMARY

K152300

SUMMARY PREPARED ON:	July 31, 2017
SUBMITTED BY:	Glytec, LLC10 Patewood Drive, Suite 100Greenville, SC 29615Phone: (864) 263-4180
CONTACT PERSON:	Julie GlendrangeGlytec, LLC10 Patewood Drive, Suite 100Greenville, SC 29615Phone: (864) 263-4180
DEVICE NAME:COMMON NAME:CLASSIFICATION:PRODUCT CODE:	Glytec GlucommanderCalculator, Drug DoseClass II, 21 CFR 868.1890 Predictive PulmonaryFunction Value CalculatorNDC
SUBSTANTIALLYEQUIVALENT DEVICE:	Glytec LLC Glucommander System (K113853,May 8, 2012)
DEVICE DESCRIPTION:	The Glucommander System is a softwarealgorithm device intended to evaluate the currentas well as cumulative patient blood glucosevalues and, based on the aggregate of thosemeasurements, whether one or many,recommend a dosage of insulin, glucose, orsaline in order to direct the blood glucose leveltowards a predetermined target range. Once thattarget blood glucose range has been reached,the system's function is to recommend a titrationof insulin, glucose, and saline for the purpose ofmaintaining the patient's blood glucose level inthat target range. The system is programmed toprovide intravenous dosing of glucose, saline,and insulin, as well as subcutaneous dosing ofinsulin for both pediatric (ages 2-17 years) andadult patients.

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INDICATIONS FOR USE:

The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.

The indications for use are identical to the predicate device.

Glucommander is a software device. The software includes security features, software upgrades, data backup capabilities and technical support. All users have their own user names and passwords to protect access to the program. All upgrades are performed from Glytec support. Glucommander ensures that it has the latest security features and that it maintains the confidentiality, integrity and availability of all information according to the HIPAA privacy

This 510(k) submission evaluated new functionality as well as modifications to existing

TECHNOLOGICAL CHARACTERISTICS:

Page 2 K152300

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features including: the Continuous Tube Feeding Module, which is designed to cover patient's receiving enteral nutrition; the Ambulatory Care Module, which is designed to provide recommendations for patients outside the hospital environment; and the Subcutaneous Module, which is designed for non-critical patients in the hospital.

These features do not raise different questions of safety or effectiveness. Non-clinical performance data was used to demonstrate that the device is substantially equivalent to the predicate device.

PERFORMANCE DATA: The 510k submission included software, cybersecurity, and human factors documentation to demonstrate the performance of the device is substantially equivalent to the predicate.
SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the Glucommander System to the predicate device. The proposed enhancements have the same indications for use, are similar in design, have the same fundamental scientific technology, and are tested the same way as the predicate device. As detailed in the submission, the subject device is as safe and as effective as the predicate device.

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

August 4, 2017

Glytec, LLC Julie Glendrange Sr. Director, Product Services and Regulatory Compliance 10 Patewood Drive, Suite 100 Greenville, SC 29615

Re: K152300

Trade/Device Name: Glytec Glucommander Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: February 23, 2017 Received: February 24, 2017

Dear Julie Glendrange:

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.

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 of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

for

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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).