(26 days)
The Acuity system is intended to be used by skilled clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. The Acuity system consists of the Acuity® Central Monitoring Station. Acuity software, FlexNet™ communications network and Welch Allyn vital signs monitors. The vital signs monitors can operate standalone (according to their individual Intended Use Statement) or be networked to the Acuity central monitoring station through the Acuity FlexNet communication network.
In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis.
- . Full Disclosure stores patient data for up to 96 hours.
- Arrhythmia monitoring module provides real-time monitoring and alarms for specific . changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
- ST analysis module provides real-time monitoring and alarms for ST segment deviations, . from a reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each detected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
The most likely locations for patients monitored by an Acuity system are step-down units, telemetry departments, general med/surg floors and emergency departments. The Acuity system is available for sale only upon the order of a physician or licensed health care professional.
The Acuity system comprises four components: the Acuity Central Monitoring Station, Acuity software, the FlexNet™ communications network, and Welch Allyn vital signs monitors. The Acuity Central Monitoring Station is the heart of the system, using hardware provided by Sun Microsystems, Inc. The Acaity Central Monitation Station, Shippetwork devices on the FlexNet Betweek uring hardwired Ethernet connections (IEEE 802.3-compliant) or wireless Ethernet connections (IEEE 802.11compliant).
The Acuity software operating system is Solaris™, the Unix®-based operating system from Sun Microsystems. Welch Allyn Protocol's application software provides the routines and services required to accomplish the tasks associated with central patient monitoring. These tasks include the user interface, communication with patient monitors, management of alarms and settings, and recording and review of patient data.
The Archythmia Analysis and ST Analysis options are being replaced with Mortara Instrument's arrhythmia algorithm software module. Mortara Instrument's arrhythmia software will now provide the data analysis for both the Arrhythmia Analysis and the ST Analysis options.
The Acuity application software receives the output from the Mortara software module and records the results in the same manner as the previous version of Acuity software. There are only a few minor changes to the user interface as described in the Acuity Directions For Use.
The Acuity hardware and software operating system are not changed.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a formal table with pass/fail thresholds. However, it implicitly sets performance expectations by comparing the new software module to the previous one and by presenting specific performance metrics from a standalone test.
Implicit Acceptance Criteria and Reported Performance:
| Metric / Implied Criteria | Reported Device Performance |
|---|---|
| Overall Performance (vs. prior module) | Improved performance (Mortara software module outperformed the current arrhythmia module in the Acuity system). |
| Integration Impact on Existing Acuity Software | Minimum impact on existing Acuity software (displays, alarms, trending control, communications). |
| ORS Complex Detection Rate | 100% of the ORS complexes were detected. |
| Arrhythmia Event Identification (Labeling) Accuracy | Arrhythmia events were correctly identified (labeled). |
| Arrhythmia Event False Positives | Less than 3% event false positives. |
| Ventricular Beat Mislabelling Rate | Less than 1% of the ventricular beats were mislabeled. (Specific example: 3 mislabeled ventricular beats in 1600 beats in one test case leading to one less false positive event identification). |
| Agreement between Standalone and Networked Systems | Data from a standalone system was compared to a fully configured (networked) system and indicated consistent performance for ORS detection and arrhythmia event identification, with slight deviation in mislabeled ventricular beats in one specific instance (affecting false positives for events). |
Study Details
The document describes performance testing conducted to evaluate the new Mortara arrhythmia software module within the Acuity system.
2. Sample Size and Data Provenance:
- Test Set Sample Size: "one test case, which included 1600 beats". This refers to the specific instance where 3 ventricular beats were mislabeled. The document also mentions "playback files" being used, suggesting a standardized set of ECG recordings.
- Data Provenance: Not specified, but the use of "playback files" implies pre-recorded data, likely retrospective. There is no mention of country of origin.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document does not describe how the ground truth for the test playback files was established or who established it.
4. Adjudication Method:
- Adjudication Method: Not specified.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. The study focuses on the performance of the algorithm itself and mentions the improvement of the Mortara software module over the prior Acuity software module. It does not describe human readers using the AI-assisted system and comparing their performance to human readers without AI assistance.
6. Standalone (Algorithm Only) Performance:
- Was it done?: Yes. The text explicitly states: "A standalone (non-networked) Acuity system with a single patient monitor connected was also tested with the same playback files." This represents a standalone evaluation of the algorithm's performance.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not explicitly stated, but based on the context of "playback files" and evaluating arrhythmia detection and labeling, the ground truth would most likely be expert consensus on ECG interpretations or potentially derived from established, adjudicated databases of ECG recordings. The document doesn't provide enough detail to definitively confirm this, but it is implied by the nature of arrhythmia analysis.
8. Sample Size for the Training Set:
- Sample Size: Not specified. The document focuses on the testing of the Mortara module within the Acuity system, not on the development or training of the Mortara algorithm itself.
9. How Ground Truth for the Training Set Was Established:
- How Established: Not specified. As with the training set size, this information pertains to the development of the Mortara algorithm, which is not detailed in this submission.
§ 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.