(177 days)
The IMRACT Pager System is intended to be used for the annunciation of events within a zone coverage area that is secondary to the primary care that is provided. Primary care via the central station, patient bedside monitor, or telemetry system remains unchanged. This device is intended to be used within the hospital/facility environment.
The IMPACT pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's aftention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of the IMPACT pager.
The provided 510(k) summary for the Marquette IMPACT Pager System focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone performance for a medical device that makes diagnostic or treatment decisions.
The IMPACT Pager System is described as a device for "annunciation of events to provide zone information that is secondary to the primary care provided." It is explicitly stated that "Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of the IMPACT pager." This indicates that the device does not perform primary diagnostic or therapeutic functions, but rather relays information.
Therefore, the typical metrics like sensitivity, specificity, accuracy, or MRMC study results, which are common for AI/ML-driven diagnostic or prognostic devices, are not applicable or reported for this type of device. The "performance" here refers more to reliable functionality and information transmission.
Here's the breakdown of the information that is available based on the provided text, and where some requested information is not applicable (N/A) or not provided:
Acceptance Criteria and Study for Marquette IMPACT Pager System (K971868)
The submission indicates that the device is a "pager system" for "annunciation of events" and is "secondary to the primary care provided." The performance testing focused on functional correctness and safety, rather than diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Safety and Electrical/Mechanical | Compliance with U.L. listing/classification for non-patient environment components (CardioPager Server, Micro Serial Server, Pager Transmitter). | U.L. Listing or Classification reviewed and found appropriate. |
| Compliance with specified electrical and mechanical performance and safety tests by Marquette's reliability group. | Additional electrical and mechanical performance and safety tests were performed as specified and included in the submission. | |
| Functional Performance (Information Accuracy) | Correct replication of arrhythmia type, heart rate, and waveform information from the primary monitoring system at the pager. | Information at the pager was "checked for correctness" during functional performance testing. The "CardioPager replicates arrhythmia type, heart rate, and waveform information obtained from the monitoring system via Ethernet." |
| Administrator Application | Proper functioning of the administrator application running on the server. | The test plan "fully exercised the administrator application running on the server." |
| Alarm Monitoring Services | Proper operation of the Unity™ alarm monitoring services of the CardioPager server. | The test plan "fully exercised...the operation of the Unity™ alarm monitoring services of the CardioPager server." |
| Intended Use | Device meets the requirements of its intended use. | "Validation test results indicated that the IMPACT Pager System met the requirements of its intended use." (Intended use is defined as secondary annunciation of events within a zone coverage area, within a hospital/facility environment.) |
| Substantial Equivalence | As safe and effective, and performs substantially equivalent to the ADU/ Pager-LAN System (K962827). | "Marquette Medical Systems has demonstrated that use of the IMPACT Pager System is as safe and effective, and performs substantially equivalent to use of the ADU/ Pager-LAN System." FDA concurred with substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly specified. The text mentions "functional performance testing" and "validation test results" indicating a test set was used, but the number of test cases, durations, or specific scenarios are not provided in the summary.
- Data Provenance: Not specified, but likely internal testing performed by Marquette Medical Systems. As it's a pager system, the "data" would be the simulated or live alarm/event information being transmitted.
- Retrospective/Prospective: Neither term is used. The testing described appears to be prospective functional and safety testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable or not specified. Given the nature of the device (a pager for event annunciation), "ground truth" would be the correct transmission of information. The "correctness" was likely verified against the source (primary monitoring system) by technical personnel, not by medical experts establishing a diagnostic ground truth.
- Qualifications of Experts: N/A for diagnostic "ground truth." Marquette's "Technical Coordinator" reviewed UL listings, and "reliability group" performed safety tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not explicitly described. Since the "truth" is the direct replication of information from a primary system, adjudication by multiple human readers for diagnostic accuracy is not relevant to this device's function.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done. This type of study is for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the function of a pager system.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: While the "CardioPager replicates arrhythmia type, heart rate, and waveform information..." and "this information was compared for correctness during the functional performance testing," this isn't a "standalone" performance in the AI/ML sense (e.g., reporting sensitivity/specificity of an algorithm making a diagnosis). It's a functional test of the system's ability to accurately transmit information. No specific metrics like sensitivity or specificity for its own "interpretations" (as it doesn't interpret, it replicates) are provided. The "algorithm" here is essentially the software logic for data transmission and display.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the functional performance testing was the output of the primary patient monitoring system (e.g., "arrhythmia type, heart rate, and waveform information obtained from the monitoring system"). The pager's output was compared against this primary source for correctness.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable / Not specified. This device does not appear to be an AI/ML device that requires a training set in the conventional sense. Its function is information relay, not learning from data to perform a diagnostic or predictive task.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. There is no mention of a training set or an AI/ML component that requires training data in the provided summary.
§ 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).