(27 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 operational 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 selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
The Acuity® Central Monitoring System (Acuity System) is Welch Allyn's central monitoring solution. It consists of a central monitoring station, Acuity System software and a collection of other commercially available networking products.
The Acuity System is intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors. This solution leverages networking and connectivity to obtain and distribute patient information where and when needed. The overall performance of the networked system is based upon trending and data management techniques consistent with industry practice and applicable standards.
The Acuity System is available in multiple product configurations. Acuity Systems can be customized to meet a customer's unique needs based on hospital policy, health care facility size and patient census and floor layout. In all cases, the user must carefully review the features and functionality of the Acuity System to ensure that selected configurations meet specific clinical needs. The Acuity System supports patient information management, patient vital-sign alarm and equipment alert management, patient data and waveform monitoring and review, system administration and ongoing service. Acuity System software modules and devices support adult, pediatric and neonatal patients, except where indicated below. Acuity System software can include the following optional modules:
- · The Full Disclosure module stores patient data for up to 96 hours.
- · The Arrhythmia Analysis 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 Analysis module is not intended for use with neonatal patients.
- · The ST Analysis module provides real-time monitoring and alarms for STsegment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST-segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
- · The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Web Server (Acuity System patient printout files available on Web browsers), AcuityLink® (Acuity System patient information delivered to mobile devices) with Clinician Notifier Barcode Interface, HL7 Interface options, and Third Party Data Stream Interface.
Acuity System software further processes data acquired from patient monitors. Acuity Systems with the Arrhythmia Analysis module calculates heart rate using multiple ECG leads and arrhythmia analysis algorithms
The Acuity System is not directly connected to patients. It is designed to be used as a central monitoring system for a set of patient monitors that support both continuously and intermittently acquired data. Supported monitors include, but are not limited to, the following Welch Allyn devices: Propaq® Encore, Propaq CS, Propaq LT, Micropage, and the Welch Allyn 1500 Patient Monitor, as configured to interface with the Acuity System.
The Acuity System and distributed monitoring devices are prescription devices to be used by authorized health care professionals using standard institutional procedures and standards of care for patient monitoring. Staff training in the operation of the Acuity System and the patient monitoring devices connected to it is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' vital-signs data. Individuals using the Acuity System should be familiar with its operation as described in the manual, and they should understand all warnings and cautions in the manual.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Welch Allyn Acuity® Central Monitoring Station:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in the way typically seen for algorithmic-based devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant medical device standards.
However, based on the information provided, we can infer the overarching "acceptance criteria" and the reported "performance" based on the regulatory submission process:
| Feature | Acceptance Criteria (Inferred from regulatory submission) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Overall Safety & Effectiveness | Device is as safe, as effective, and performs as well as the currently marketed predicate device (K052160). | "Welch Allyn's Acuity Central Monitoring Station is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed device cited in this submission." |
| Compliance with Standards | Device passed tests and verified compliance with relevant medical device standards for electrical safety, EMC, risk management, software lifecycle, and cardiac rhythm/ST-segment algorithms (e.g., IEC 60601-1, IEC 60950-1, IEC 60601-1-2, ISO 14971, IEC 62304, ANSI/AAMI EC57, IEC 60601-1-4). | "The Acuity® Central Monitoring Station was tested to evaluate its safety and effectiveness based on the following standards: [lists standards...]" The conclusion of substantial equivalence implies successful adherence to these standards. |
| Functional Equivalence | The device exhibits the same technological characteristics and indications for use as the predicate device, with minor modifications for user enhancements. | "The subject device has the same technological characteristics and indications for use as the predicate device; minor modifications and additions to software and hardware were made to the Acuity® Central Monitoring Station for user enhancements." The system supports patient information management, vital-sign alarm/alert management, data/waveform monitoring and review, system administration, and optional modules like full disclosure, arrhythmia analysis, and ST analysis. |
| Intended Use | The device functions for the central monitoring of neonatal, pediatric, and adult patients in healthcare facilities, including real-time monitoring and alarms for cardiac rhythms and ST-segments (excluding neonates for arrhythmia and ST analysis). | The Indications for Use statement confirms this. The system "provides real-time monitoring and alarms for specific changes in cardiac rhythms" and "real-time monitoring and alarms for ST-segment deviations." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The 510(k) summary states, "Verification and validation were conducted to ensure expected performance of the Acuity® Central Monitoring Station," and that the device was "tested to evaluate its safety and effectiveness based on the following standards." However, it does not detail the specific datasets or their sizes used for these tests, particularly for the arrhythmia and ST-segment algorithms.
- Data Provenance: Not specified. The document does not indicate the country of origin of any data used for testing, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. Given that no clinical studies were utilized for obtaining safety or effectiveness data, and the primary assessment relied on non-clinical tests and substantial equivalence, there's no mention of expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. As no clinical studies or specific test sets requiring expert ground truth adjudication are detailed, this information is not present.
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 MRMC comparative effectiveness study was mentioned or performed. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." This device is a central monitoring station with analytical modules, not a diagnostic AI intended to assist human readers in image interpretation or similar tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a form of standalone testing was performed for the algorithms, though not in a typical "AI" context. The document states: "Acuity Systems with the Arrhythmia Analysis module calculates heart rate using multiple ECG leads and arrhythmia analysis algorithms." It also mentions "ST Analysis module provides real-time monitoring and alarms for ST-segment deviations."
- Furthermore, one of the standards the device was tested against is ANSI/AAMI EC57: 1998 "Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms." This standard specifically details methods for evaluating the performance of these algorithms, which inherently involves testing their "standalone" capability to detect and measure cardiac rhythm events and ST-segment deviations. The conclusion of substantial equivalence implies these algorithms met the performance requirements outlined in EC57.
- However, the document does not provide the specific performance results (e.g., sensitivity, specificity for arrhythmia detection; accuracy for ST measurement) that would typically be reported from such standalone testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for the arrhythmia and ST-segment algorithms. Given the reliance on ANSI/AAMI EC57, it's highly likely that ground truth for the performance testing of the arrhythmia and ST-segment algorithms would have been established through a combination of:
- Manual review by expert cardiologists/technicians: This is a common method for annotating ECG datasets used in such testing.
- Annotated public or proprietary ECG databases: Many standardized databases (e.g., MIT-BIH Arrhythmia Database) have expert-validated annotations that serve as ground truth for algorithm testing.
- The document does not provide specifics.
8. The Sample Size for the Training Set
- The document does not mention a training set or any details about how the arrhythmia and ST-segment algorithms were developed beyond stating they are "algorithms." This is typical for submissions of devices using established algorithms that may have been developed over many years, potentially pre-dating the common detailed reporting of "training sets" for deep learning AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As no training set is mentioned, the method for establishing its ground truth is also not provided.
§ 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.