(171 days)
RescueNet Link is intended for use in the collection and display of data that is entered by a user (caregiver), or captured from specified medical devices or from a vehicle navigation system. RescueNet Link is indicated for use by health care providers whenever there is a need for collection and display of patient, care reporting and transport data.
The proposed RescueNet Link is a software-only product. The ZOLL RescueNet Link system is an Emergency Medical Services (EMS) data system that electronically captures and displays patient monitoring, charting and ambulance location and navigation system data within the ambulance and communicates it for display to other locations throughout the pre-hospital and inhospital system of care. The system is comprised of two computer hardware/software based components, MobileLink and FieldLink. Both components use general purpose, commercially available computers, networking and communications hardware combined with software supplied by ZOLL. The MobileLink component resides within each EMS ambulance where it collects, integrates and displays patient monitoring, care reporting and ambulance location and navigation data on a large, easy to read touch screen display. Patient, care and transport data collected by MobileLink are transmitted to a central FieldLink server via cellular/internet connections. This server provides a distribution point from which internet accessible web pages displaying the information collected within each ambulance can be viewed. The FieldLink server also provides each receiving hospital with web pages showing information about the MobileLink-equipped ambulances currently on route to the medical facility and monitoring and charting information about the patients they are transporting. RescueNet Link is non-alarming software.
The provided text is a 510(k) summary for the ZOLL RescueNet Link device, which is a software-only product for collecting and displaying patient, care reporting, and transport data in emergency medical services (EMS) settings.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific, quantified performance results. Instead, it makes a general statement about performance testing:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs as well as predicates | "Extensive performance testing ensures that RescueNet Link performs as well as, and meets all of its functional requirements and performance specifications." |
| Meets functional requirements | "Extensive performance testing ensures that RescueNet Link performs as well as, and meets all of its functional requirements and performance specifications." |
| Meets performance specifications | "Extensive performance testing ensures that RescueNet Link performs as well as, and meets all of its functional requirements and performance specifications." |
| Substantially equivalent in performance, safety, and effectiveness to predicate device. | "Performance testing of RescueNet Link demonstrates that its features and functions are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for performance testing (e.g., number of cases, records, or patients). It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information about the number of experts used to establish ground truth or their qualifications. Given that this is a data collection and display system, and not an AI-driven diagnostic tool, the concept of "ground truth" derived from expert consensus may not directly apply in the same way. The performance testing likely focused on the accuracy and reliability of data capture, transmission, and display compared to expected system behavior.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none). This information is typically relevant for studies where subjective interpretation or complex diagnostic decisions are involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic AI tools where human reader performance is being evaluated with and without AI assistance. The ZOLL RescueNet Link is described as a data collection and display system, not a diagnostic AI.
6. Standalone (Algorithm Only) Performance Study
The document describes "Performance Testing" which indicates a standalone evaluation of the algorithm's functionality and specifications. However, it does not explicitly label it as a "standalone (i.e. algorithm only without human-in-the-loop performance) study." The device is a "software-only product" and the testing would assess its software features and functions.
7. Type of Ground Truth Used
The document implies that the ground truth for performance testing would be based on the expected functional requirements and performance specifications of the device, likely assessed against reference data or simulated scenarios to ensure accurate data collection, transmission, and display. It does not mention pathology, outcomes data, or expert consensus in the context of establishing ground truth for this device's performance.
8. Sample Size for the Training Set
As this device is a software system for data collection and display and not a machine learning or AI model in the sense of predictive analytics or image analysis, there is no mention of a "training set" in the document.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the method for establishing its ground truth is also not applicable or described.
§ 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).