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The MDN-CGS™ Insulin Dosing Calculator is intended to evaluate the current patient blood glucose values. Based on the measurements, the software will calculate either a dose of glucose or insulin to drive the blood glucose level up or down toward a predetermined target range. Once that target blood glucose range has been reached, the software program calculates dosing of insulin or glucose 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 glucose or insulin. The device is intended for use with patients with no known insulin allergies and for patients over the age of 18.

The MDN-CGS™ Insulin Dosing Calculator programmed logic is a tool and not a substitute for, but rather an assist to, clinical reasoning. The measurements and calculations generated by the MDN-CGS™ Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel directed by physician order. No medical decisions are to be made solely on the guidance provided by this software program, but are to include consideration of clinical history, symptoms, other diagnostic measurements, and the professional's clinical judgment.

The MDN-CGS ™ Insulin Dosing Calculator 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. The MDN-CGSTM Insulin Dosing Calculator also provides alerts for subsequent blood glucose testing and monitoring.

The provided document, a 510(k) summary for the Clarian Glucose Stabilizer Insulin Dosing Calculator (MDN-CGS™ Insulin Dosing Calculator), does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study particulars. Medical Device Network (MDN) is stated as the submitter.

Here's an analysis of what can be extracted and what is missing:

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

The document does not provide a table of acceptance criteria or reported device performance metrics. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting the results of a performance study against predefined criteria.

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

This information is not included in the provided text. The document does not describe any specific test set or data used for validation.

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)

This information is not available. As there is no described test set or ground truth establishment process, details about experts are absent.

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

This information is not available. No adjudication method is mentioned.

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

There is no indication of an MRMC comparative effectiveness study being performed or whether human readers improve with AI assistance. The device is a "Drug Dose Calculator" and not an imaging AI system that would typically involve human readers. The document states it is "a tool and not a substitute for, but rather an assist to, clinical reasoning."

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

The document describes the MDN-CGS™ Insulin Dosing Calculator as a "standalone software device". However, it explicitly states its calculations are "intended to be used by qualified and trained medical personnel directed by physician order" and "No medical decisions are to be made solely on the guidance provided by this software program, but are to include consideration of clinical history, symptoms, other diagnostic measurements, and the professional's clinical judgment." This implies it does not operate fully in a standalone capacity for patient care decisions, but rather as an aid. The study details to confirm standalone performance (e.g., accuracy of calculations in a simulated environment) are not provided.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. The document describes the device's logic, but not how it was developed or trained.

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

This information is not provided.

Summary of available information:

The provided document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices (EndoTool™ Drug Dose Calculator and Glucommander Plus™) for regulatory clearance. It describes the device's intended use and functionality, stating it is a web-based software that automates calculations for intravenous insulin/glucose dosing and provides alerts. It emphasizes that the device is an "assist to, clinical reasoning" and not a substitute, requiring use by qualified medical personnel. The key argument for substantial equivalence rests on similar intended use, indications, technological characteristics, and principles of operation, with the main difference being the MDN-CGS™ is a standalone software device, unlike its accessories-to-pump predicates. However, it does not contain the detailed performance validation study information typically found when describing acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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