(129 days)
The Acuity® Central Monitoring Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.
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 eilance 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 . B r unalyons from a reference beat, for patients with suspected heart disease and avomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
The Acuity® Central Monitoring Station is Welch Allyn's Central Monitoring solution. It consists of the I no routy® Central Monitoring Station, the Acuity software and a collection of other commercially available networking hardware products. The system connects to a network of patient monitors to record and analyze the data being acquired by those devices. This solution offers a proven record and untily to the auto and features needed to support a distributed network of connected devices while providing arrhythmia detection and alarms for adult and pediatric patients.
The Acuity system supports patient information management, patient alert and alarm management, rite noaty oyotem administration and product installation and service. It leverages various networking and connectivity options to obtain and distribute information where and when needed.
Acuity is available in multiple product configurations. Acuity systems can be ordered off-the-shelf or custom configured to meet a customer's unique needs based on hospital policy, healthcare Shell of custom conlingured to meet a oaster. In all cases, the user must carefully review the features facility size, patient cerisus and noor rayour and the Acuity® Central Monitoring Station to ensure that clinical needs are met.
The Acuity® Central Monitoring Station is not directly connected to patients. It is designed to be used The Aculty® Octitur Monitoring Station of patient monitors supporting both continuously and as a central monkoning oyeten for a sites supported include, but are not limited to, the following interfilterity acquired duta: The mentlers supported to interface with Acuity.
Acuity systems monitor patient data supplied by a bedside monitor and do further processing of that Aculty Systems monitor pation acts eappliering Station. Acuity systems with the arrhythmia option data by Sollware at the Acally® Oontral mornethmia analysis algorithms, where the bedside calculate heart rate algorithm based on data from a single ECG lead. The overall performance monitor uses a ficult rato algontining and data management techniques consistent with industry practice and applicable standards.
It is important to note that some Acuity software options and/or devices will support adult and it is important to not other neonatal patients. Specifically, the ST Analysis and Arrhythmia Analysis software options are intended only for adult and pediatric patients.
Acuity® Central Monitoring Stations and distributed monitoring devices are prescription devices to be Aculty® Ochrail Mohitoring blancher by institutional standard procedures and good clinical practice guidelines for monitoring of specific patients. Staff trained in the operation of Acuity clinical praction monitoring devices connected to it is essential for optimal use. System users should and the patient monitoring doniose connese, physician, healthcare provider or medical specialist.
The Acuity® Central Monitoring Station is an arrhythmia detector and alarm system. The summary provided outlines its acceptance criteria and performance data.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Predicate Device K022453) | Reported Device Performance (Acuity® Central Monitoring Station) |
|---|---|---|
| QRS Detection Sensitivity | AHA 99.88, MIT 99.93 | AHA 99.86, MIT 99.95 |
| QRS Positive Predictivity | N/A (not explicitly listed for predicate) | 99.89 |
| Ventricular Sensitivity | N/A (not explicitly listed for predicate) | 93.26 |
| Ventricular Positive Predictivity | N/A (not explicitly listed for predicate) | 98.21 |
Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new, specific acceptance criteria beyond what the predicates met. The "Acceptance Criteria" column refers to the predicate device's performance, which the subject device aims to meet or exceed to prove substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for a "test set" in the traditional sense of a clinical trial. The performance data presented (QRS Sensitivity, Predictivity, Ventricular Sensitivity, Predictivity) are common metrics for arrhythmia detection algorithms, typically evaluated against standardized databases.
- Sample Size: Not explicitly stated as a single "test set" size. The performance metrics are likely derived from evaluation against recognized datasets like the AHA (American Heart Association) and MIT (Massachusetts Institute of Technology) arrhythmia databases, which contain a large number of ECG recordings.
- Data Provenance: The data refers to "AHA" and "MIT," which are well-known, publicly available, and extensively used retrospective ECG databases for arrhythmia algorithm testing. These databases consist of recordings from various patients and are widely accepted for benchmarking. The country of origin for these databases is primarily the United States (MIT) and, for AHA, data can be internationally sourced but compiled under AHA standards. The data is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the test sets (AHA and MIT databases). For these widely used databases, the ground truth annotations were established by a panel of expert cardiologists or electrophysiologists based on visual inspection and agreed-upon guidelines, long before the Welch Allyn study. The exact number and specific qualifications of those original annotators are not provided in this document but are part of the original database documentation.
4. Adjudication Method for the Test Set
The document does not describe a new adjudication method for a specific test set created by Welch Allyn. For the AHA and MIT databases, the ground truth labels are pre-established through expert consensus during the creation of these databases. The exact adjudication method (e.g., 2+1, 3+1) used for the original annotation of these large public databases is not detailed in this 510(k) summary but would have involved multiple experts reviewing and agreeing upon classifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The study focuses on the standalone performance of the device's arrhythmia detection algorithms compared to predicate devices and established benchmarks.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, a standalone (algorithm only) performance evaluation was done. The provided "QRS Detection Sensitivity," "QRS Positive Predictivity," "Ventricular Sensitivity," and "Ventricular Positive Predictivity" are metrics that assess the algorithm's performance directly against the ground truth of the ECG databases (AHA and MIT) without human intervention in the loop.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance metrics (QRS and Ventricular detection) is based on expert consensus annotations from the AHA and MIT ECG databases. These databases contain expertly reviewed and annotated ECG waveforms over extended periods, identifying QRS complexes and various arrhythmia events.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for the training set used to develop the Acuity® Central Monitoring Station's arrhythmia algorithms. 510(k) summaries typically focus on the performance against independent test sets for substantial equivalence, not the details of algorithm development (training data, methodology, etc.).
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. As with the test set, it is highly probable that the training data would also have been expertly annotated, likely using similar methodologies (expert consensus) as the publicly available test databases or proprietary datasets.
§ 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.