(27 days)
The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals.
The AlarmView™ Wireless Data Network System is limited to use by qualified medical professionals who have been trained on the use of the device. It is for use in hospital type environments and is not for home use.
The AlarmView™ Wireless Data Network System is to supplement and not replace any part of the current device monitoring procedure.
The AlarmView™ Wireless Data Network System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that provides secondary annunciation of primary medical device alarms via wireless communication devices carried by healthcare professionals.
The provided text for the AlarmView™ Wireless Data Network System's 510(k) summary (JUL 24 2001) does not contain detailed acceptance criteria or a specific study demonstrating device performance against such criteria in the way a diagnostic AI device submission would. This 510(k) is for a "Wireless Data Network System" that provides secondary annunciation of medical device alarms, not an AI/ML-driven diagnostic tool.
The submission focuses on establishing substantial equivalence to an existing predicate device (AlarmView™ Wireless Data Network System, K010912), rather than proving diagnostic performance against quantitative metrics like sensitivity or specificity.
Therefore, many of the requested fields cannot be answered based on the provided document.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document as quantitative performance metrics for a diagnostic device. The submission focuses on substantial equivalence to a predicate, implying it meets the same implicit safety and effectiveness standards. | "Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. The document doesn't describe a "test set" in the context of diagnostic performance evaluation with patient data. The "validation testing" likely refers to engineering verification and validation of system functionality and performance characteristics rather than clinical data evaluation.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not provided. Ground truth establishment is not relevant for this type of device submission.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is not an AI-driven diagnostic device; it's a wireless alarm notification system.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an algorithm, but a hardware/software system designed to relay information to humans. Its function is inherently "human-in-the-loop."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable/Not provided.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not provided. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable/Not provided.
Summary of Study (Based on provided text):
The submission describes a "validation testing" and "risk analysis" as the basis for demonstrating safety and effectiveness. The "study" (or rather, the basis for approval) is centered around showing substantial equivalence to an already legally marketed predicate device (K010912). The key finding is: "Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device."
This indicates that the validation focused on ensuring the modified device performs its intended functions (receiving and annunciating alarms wirelessly) safely and effectively, similar to the predicate, and does not introduce new questions of safety or effectiveness. It's a regulatory "comparison" rather than a clinical trial or AI performance study.
§ 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).