(46 days)
The G+ System is 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, regulate the infusion of I.V. fluids, through and I.V. infusion pump, and drive 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 provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The G+ System logic is not a substitute for, but rather an assist 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 guidance provided by this software program.
The Glytec, LLC G+ System is a software 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, regulate the infusion of I.V. fluids, through an I.V. infusion pump, and 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 provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The device is available in a Standard Edition or server based Enterprise Edition.
This 510(k) summary does not contain the detailed information required to fill out all the sections of your request regarding acceptance criteria and a study proving those criteria are met. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a new, comprehensive performance study that establishes and validates new acceptance criteria.
Here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance:
This document does not provide explicit acceptance criteria or detailed performance metrics. The core of this 510(k) is a declaration of substantial equivalence to a predicate device (CollaborativeMed, LLC, Glucommander Plus #K061110). Studies demonstrating new performance would have been required for a device that wasn't substantially equivalent to a predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No information is provided regarding a test set sample size or data provenance for a performance study. Since this is a Special 510(k) and focuses on substantial equivalence, it's likely they are relying on the predicate device's established performance without conducting new, extensive performance trials.
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):
No information is provided regarding experts or ground truth establishment for a test set. This would be relevant if a new performance study were conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No information is provided on an adjudication method, as there's no mention of a performance study with a test set.
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 information is provided about an MRMC study or the effect size of human improvement with AI assistance. This document describes a software device for dose calculation, not an AI for image interpretation or diagnosis where MRMC studies are common.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device description explicitly states: "The G+ System logic is not a substitute for, but rather an assist to clinical reasoning... No medical decision should be based solely on the recommended guidance provided by this software program." This indicates it's designed for use with human-in-the-loop. Therefore, a standalone performance study in the sense of a fully autonomous algorithm acting without human oversight would contradict its intended use. However, no specific standalone performance study results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No information is provided regarding the type of ground truth used, as there's no mention of a new performance study requiring ground truth establishment.
8. The sample size for the training set:
No information is provided regarding a training set sample size. This document focuses on a "Special 510(k)" for modifications to an existing predicate device, implying that the core algorithms and their validation likely happened with the original device and are not being re-evaluated with a new training set.
9. How the ground truth for the training set was established:
No information is provided on how ground truth was established for a training set.
In summary:
This document is a Special 510(k), which is typically used for modifications to an existing device where the changes do not significantly affect the safety or effectiveness. The primary claim for regulatory clearance is substantial equivalence to the predicate device (CollaborativeMed, LLC, Glucommander Plus #K061110) based on an analysis of "overall performance characteristics." This type of submission generally does not require a new, comprehensive clinical or performance study with new acceptance criteria and detailed data as would be found in a Traditional 510(k) for a novel device or a device with significant changes in technology or indications. The assumption is that the predicate device already demonstrated adequate performance.
§ 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).