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The GlucoStabilizer Insulin Dosing Calculator 3.0 is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the either up or down towards a predetermined target range.

Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of insulin and dextrose for both adult and pediatric (ages 2 to

The GlucoStabilizer Insulin Dosing Calculator 3.0 is a Web-based software solution that automates calculations used by healthcare professionals to determine the appropriate intravenous insulin drip rate necessary to manage blood glucose levels across a variety of patient populations. GlucoStabilizer also provides alerts for subsequent blood glucose testing and monitoring. The GlucoStabilizer software release described in this 510(k) submission contains a modification that allows its use for pediatric patients. The pediatric protocol considers patient weight in insulin calculations for patients under the age of 18 years and provides a 3-digit multiplier for more granular calculation results. In addition, this release of GlucoStabilizer provides an optional 'multi-view'screen that allows healthcare personnel to more easily manage multiple, on-going patient treatment programs. Other features and technological characteristics of GlucoStabilizer are unchanged.

The provided document describes the GlucoStabilizer® Insulin Dosing Calculator, a software solution, and its substantial equivalence to predicate devices, particularly in the context of expanding its use to pediatric patients. However, the document does NOT contain explicit acceptance criteria (performance metrics with pass/fail thresholds) or a detailed study description with specific data on device performance against such criteria. The FDA letter is a 510(k) clearance based on substantial equivalence, not an approval based on meeting pre-defined performance metrics from a de novo clinical trial.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The 510(k) clearance is based on substantial equivalence to predicate devices (MDN-CGS™ Insulin Dosing Calculator (K071713) and Glytec LLC, Glucommander™ System (K113853)), rather than a direct demonstration against specific numerical acceptance criteria for this new version.

The document states: "The GlucoStabilizer Insulin Dosing Calculator 3.0 has the same technological characteristics and principles of operation as the MDN-CGSTM Insulin Dosing Calculator and Glytec LLC, Glucommander™ System. GlucoStabilizer 3.0 has the same intended use and similar indications as the Glucommander System. The minor technological differences between the GlucoStabilizer 3.0 and its predicates do not present any new issues of safety or effectiveness."

This implies that the device "meets" its criteria by being sufficiently similar to devices already recognized as safe and effective. No specific performance metrics (e.g., accuracy of insulin dose calculation to within X%, percentage of patients reaching target glucose within Y hours) or their corresponding results are reported for the GlucoStabilizer 3.0 itself in this document.

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

This information is not provided in the document. The 510(k) summary focuses on the comparison to predicate devices and the new features (pediatric use, multi-view screen). It does not detail a specific test set or data provenance used to evaluate the GlucoStabilizer 3.0's expanded functionality.

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

This information is not provided in the document. As no specific test set evaluation is detailed, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The clearance is based on substantial equivalence to existing devices.

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

The document does not describe a standalone study. The device is explicitly an "assist to clinical reasoning" and requires "qualified and trained medical personnel" for its use. Therefore, any evaluation would likely involve human-in-the-loop given its nature. However, no specific performance study is detailed, standalone or otherwise.

7. The Type of Ground Truth Used

Given the lack of a detailed performance study, the type of ground truth used for this specific 510(k) submission is not specified. For a device like an insulin dosing calculator, ground truth in a clinical study would typically involve a comparison of the device's recommendations against clinically optimal dosing determined by a panel of endocrinologists or an established gold-standard protocol, and ultimately, patient outcomes (blood glucose control, adverse events). However, such a study is not described here.

8. The Sample Size for the Training Set

This information is not provided in the document.

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

This information is not provided in the document, as no training set is described.

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