(50 days)
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarns and patient data analysis will be available to the care provider from the monitor.
The 8100 monitor interprets and displays real time physiological data of the patient including waveforms and numerical data. The 8100 can be custom configured to monitor ECG, Noninvasive BP (NIBP), Invasive BP (IBP), S.O2, Temperature, Respiration, CO2, N.O. O2 and Halogenated Anesthetic Agents. Arrhythmia Detection and ST Analysis software from Brentwood Medical has been incorporated into the 8100 system and uses the extant ECG hardware inputs and microprocessor to enable these capabilities. All user interface elements are provided by the existing 8100 monitor. For each patient vital parameter, the 8100 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review.
The provided document is a 510(k) summary for the Criticare Systems Inc. 8100 Vital Signs Monitor with Arrhythmia Detection and ST Analysis. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, the document does NOT contain specific acceptance criteria, detailed study design, or reported device performance metrics in the format requested. It mentions that AAMI EC-57 testing was performed by Brentwood Medical for a previous submittal (K013717) and that the device was tested with "a representative group of prerecorded ECG waveforms with abnormal beats" to document the performance of the integrated Brentwood algorithms. There is no table of acceptance criteria or reported device performance against such criteria in this document.
Therefore, many of the requested details cannot be extracted from the provided text.
Based on the information available:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the document. The document states "AAMI EC-57 testing was performed by Brentwood Medical in their previous submittal (K013717)", which is a standard for ambulatory electrocardiographs. While this implies performance against AAMI EC-57 standards, the specific acceptance criteria or how the 8100 monitor performed against them are not detailed here.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: "a representative group of prerecorded ECG waveforms with abnormal beats." No specific number is given.
- Data Provenance: Not specified.
- Retrospective or Prospective: "prerecorded ECG waveforms" suggests retrospective data.
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):
- Not specified. The document does not describe how the ground truth for the "abnormal beats" in the prerecorded ECG waveforms was established or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No, an MRMC study is not mentioned. This device is a vital signs monitor with arrhythmia and ST analysis, not an "AI" device as typically conceived for MRMC studies involving human readers' diagnostic performance. The document describes the integration of software algorithms into existing hardware.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The testing described: "To document the performance of the Brentwood algorithms when integrated into the 8100 and verify the timeliness of ECG morphology-related alarms, the 8100 was tested with a representative group of prerecorded ECG waveforms with abnormal beats." This refers to evaluating the algorithms' performance on predefined ECG data, which is a form of standalone testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied ground truth: "abnormal beats" in prerecorded ECG waveforms. The basis for declaring these beats "abnormal" (e.g., expert interpretation, pre-labeled dataset) is not explicitly stated but is typically derived from expert-annotated databases for arrhythmia analysis.
8. The sample size for the training set:
- Not specified. The document mentions the integration of Brentwood Medical's software, which implies these algorithms were pre-developed. The training set size for those algorithms is not discussed.
9. How the ground truth for the training set was established:
- Not specified. This information would pertain to the development of Brentwood Medical's algorithms, which is not detailed in this 510(k) summary.
§ 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.