(150 days)
The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is important to patient care, nursing vigilance and overall hospital operations. The EXTENSION Clinical Alert Notification solution alerts and informs the clinician about critical patient alarms by drawing an identified individual's attention to a defined patient in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. The EXTENSION Clinical Alert Notification solution is not intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with the EXTENSION Clinical on solution.
The EXTENSION Clinical Alert Notification solution is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type acute care environments and is not for home use.
The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers. The EXTENSION Clinicalion solution alerts and informs the clinician about patient alarms. The EXTENSION Inc. device is not intended to replace any part of the patient monitoring system or patient monitoring procedures already existing for the medical devices interfaced with the EXTENSION Clinical Alert Notification solution.
The EXTENSION Clinical Alert Notification solution is made up of standard telecommunications and information technology. EXTENSION develops the application software that runs on a virtual machine and is accessed by client devices (PC computers running web browsers, wireless voice over IP phone handsets).
The EXTENSION Clinical Alert Notification solutions and transmits data similarly to the predicate devices. The EXTENSION Clinical Alert Notification solution and predicate devices use similar data transmission and communications technologies.
The provided document describes the EXTENSION Clinical Alert Notification solution, a closed-loop communication system for healthcare. However, it does not contain a study that proves the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy, or a comparative effectiveness study with human readers).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ascom Cardiomax, K103634) based on technological characteristics, intended use, and compliance with voluntary standards and quality assurance measures.
Therefore, many of the requested sections regarding the study and acceptance criteria cannot be filled from the provided text.
Here's an breakdown of what can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is NOT provided in the document. The document states "The EXTENSION Clinical Alert Notification solution complies with the voluntary standards as detailed in Section 9 of this submission," but Section 9 (which would detail these standards and potentially acceptance criteria) is not included in the provided text. There are no performance metrics (e.g., accuracy, sensitivity, specificity, timeliness of alerts) explicitly stated as acceptance criteria, nor are there reported device performance numbers against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is NOT provided. The document mentions "Component level testing," "System level testing," "Performance testing," "Safety testing," and "Usability and validation testing," but it does not specify any test set sample sizes, nor the provenance (country of origin, retrospective/prospective) of any data used in these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is NOT provided. Since no specific "test set" and "ground truth" establishment process is described for performance metrics, there is no mention of experts, their number, or qualifications.
4. Adjudication Method for the Test Set
This information is NOT provided. As no specific "test set" and "ground truth" establishment process is described, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
NO, a MRMC comparative effectiveness study was NOT done (or at least, not reported in this document). The document focuses on the device's function as a "secondary means of annunciating and displaying patient alarm text" and its substantial equivalence to a predicate. It does not mention any study comparing human reader performance with and without AI assistance, nor any effect size.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) study was done
This is NOT explicitly stated in terms of a formal study with performance metrics. The device's function is inherently "human-in-the-loop" as it delivers alerts to mobile healthcare workers. While "Performance testing" is mentioned, the specifics of what this testing entailed and whether it represents a standalone algorithm performance measurement with quantifiable metrics are not provided.
7. The Type of Ground Truth Used
This information is NOT provided. As no specific performance study with a test set is detailed, the type of ground truth used (e.g., expert consensus, pathology, outcomes data) is not mentioned.
8. The Sample Size for the Training Set
This information is NOT provided. The document describes the device as application software running on a virtual machine and accessed by client devices. It does not mention any machine learning or AI components that would typically involve a "training set." Therefore, no training set sample size is applicable or provided.
9. How the Ground Truth for the Training Set was Established
This information is NOT provided. As no training set is discussed, the method for establishing its ground truth is not applicable or provided.
Summary of what the document does provide regarding device evaluation:
The document outlines an assessment based on:
- Substantial Equivalence: Comparing the device's intended use and technology (e.g., data types supported, remote access, wired/wireless connections, hardware components) to a predicate device (Ascom Cardiomax, K103634).
- Compliance with Voluntary Standards: Stating that the device "complies with the voluntary standards as detailed in Section 9 of this submission" (though Section 9 itself is absent).
- Quality Assurance Measures: Listing internal development processes like Risk analysis, Design reviews, Component level testing, System level testing, Performance testing, Safety testing, and Usability and validation testing. These are generalized statements about internal processes rather than detailed study results.
In essence, the provided text serves as a regulatory submission arguing for substantial equivalence rather than a detailed report of a performance study with quantitative acceptance criteria and results.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).