(236 days)
EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient's glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing.
EndoTool IV 3.1 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 system.
EndoTool IV 3.1 is a software system for glucose management which uses the current and cumulative qlucose values provided by the user to calculate and recommend intravenous insulin or carbohydrate doses, to adjust and maintain the patient's glucose level within a provider-ordered target range. In addition, the application can recommend a subcutaneous Basal transition insulin dose when IV insulin therapy is no longer required.
The provided text is a 510(k) summary from the FDA, detailing the premarket notification for the "EndoTool IV 3.1" device. While it outlines the device's purpose, comparison to a predicate device, and general statements about software verification and validation, it does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.
The document states:
- "Software verification and validation testing was conducted per IEC 62304."
- "Clinical testing was not required to demonstrate the safety and effectiveness of the EndoTool IV 3.1. Instead, substantial equivalence is based upon benchtop performance testing."
This indicates that the validation was primarily software-focused and benchtop (likely simulated data or internal testing against predefined rules) rather than clinical. It does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, its provenance, or whether it was retrospective/prospective.
- Information on experts used for ground truth, their qualifications, or adjudication methods.
- Details of a Multi-Reader Multi-Case (MRMC) study or its effect size.
- Results from a standalone algorithm performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
Therefore, based solely on the provided document, I cannot fulfill your request as the essential information about specific performance data, test methodologies, and ground truth establishment is not present. The document focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and conformance to a general software standard (IEC 62304).
§ 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).