FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: ECG, Invasive Blood Pressure, Temperature, Non Invasive Blood Pressure, CO2, etCO2, CO2ins, SpO2, and pulse rate. There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. The system is intended for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

AI/ML Overview

The provided document is a 510(k) summary for the SCHILLER AG Argus LCM Monitoring System, comparing it to predicate devices. It states that the device is "as safe and effective as" the predicate devices and passed relevant electrical safety and software quality tests. However, it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met in the format of the output.

Specifically:

Acceptance Criteria and Reported Device Performance Table: The document lists standards passed for various components (e.g., IEC 60601-1 for System, IEC 60601-2-2 for ECG). However, it does not provide specific acceptance criteria values (e.g., accuracy +/- X%) or numerical reported device performance against those criteria. Instead, it generally states "All tests are passed" or refers to compliance with standards.
Sample size and data provenance for test set: Not available. The document states "B2 Clinical Tests: n.a." (not applicable), indicating no clinical tests were performed for this submission. The non-clinical tests mentioned are electrical safety and software quality.
Number of experts and qualifications for ground truth: Not applicable, as no clinical study with ground truth established by experts is described.
Adjudication method for test set: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone (algorithm-only) performance: Not applicable, as the device is a monitoring system and the performance evaluation focuses on hardware components and electrical safety, not an algorithm's standalone diagnostic performance.
Type of ground truth used: Not applicable, as no clinical study is described. The "ground truth" for the non-clinical tests would be the specifications and requirements of the standards themselves.
Sample size for training set: Not applicable, as no machine learning algorithm development is described in detail that would require a 'training set'. The software quality section refers to software requirements, development, verification, validation, and testing, but not in the context of a machine learning model.
How ground truth for training set was established: Not applicable.

Therefore, since the document pertains to a medical device submission primarily focused on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, the requested clinical study-centric details are not present.

Summary

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.