(85 days)
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No
The document describes a software algorithm for ECG analysis but does not mention AI, ML, or related terms. The performance studies and testing methods described are typical for traditional signal processing algorithms.
No.
The device is a software engine that analyzes ECG signals and provides parameters, events, and alarms for monitoring cardiac conditions, rather than directly treating a disease or condition.
Yes
This device is designed to continuously monitor cardiac arrhythmia and ST segments, analyze patient ECGs, and produce parameters, events, and alarms, all of which are for gaining information for treatment or ruling out causes of symptoms. These functions are characteristic of a diagnostic device.
Yes
The device is explicitly described as a "software device" and an "algorithm software device" that functions as an "analysis engine" within host computing devices. It analyzes ECG signals and produces parameters, events, and alarms. The description emphasizes its machine independence and portability, further supporting its classification as software.
Based on the provided information, the STAR ST and Arrhythmia algorithm software device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside the body (in vitro).
- STAR's function: The STAR device analyzes ECG signals obtained from electrodes attached to the skin. This is a measurement of electrical activity within the body, not a test performed on a sample taken from the body.
- Input: The input is an ECG signal, not a biological sample.
- Purpose: The purpose is to monitor cardiac arrhythmia and ST segment changes based on real-time electrical signals from the heart, not to analyze a biological sample for diagnostic markers.
Therefore, while STAR is a medical device used for diagnostic purposes (providing information for treatment or ruling out causes of symptoms), it does not fit the definition of an In Vitro Diagnostic. It is a device that analyzes physiological signals obtained directly from the patient's body.
N/A
Intended Use / Indications for Use
The indications for use of the STAR ST and Arrhythmia algorithm software device are:
- · Condition: the clinician decides to continuously monitor cardiac arrhythmia and / or ST segment.
- · Part of body or type of tissue interacted with: ECG signal obtained from electrodes attached to the skin of adult, pediatric, and neonatal patients
- · Frequency of use: As prescribed by clinician.
- · Physiological purpose: To gain information for treatment or to rule out causes of symptoms.
- Prescription versus over-the-counter: STAR is a . prescription device
Product codes
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Device Description
STAR is a software device that is intended to be used as the ST and Arrhythmia analysis engine in host computing devices. It can be ported to host computing devices that meet STAR specifications. The STAR device provides ST Analysis, Cardiotach Analysis, and Arrhythmia Analysis capability to compatible computing host devices. The STAR (ST and Arrhythmia) algorithm is a software engine that analyzes patient ECG's and produces parameters, events and alarms. It is designed so that it is machine (host) independent and can, therefore be used in more than one device. STAR currently operates in the Windows NT, UNIX and a proprietary HP real-time operating system. STAR has a fully specified ECG signal interface, control interface, and output signal interface as well as operating environment specifications.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonatal, pediatric, or adult patients.
Intended User / Care Setting
Clinicians, professional health care facility.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Publicly available data bases used to validate STAR performance included the MIT, AHA, Creighton University, and European Society of Cardiology (ESC) ST-T databases.
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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CHAPTER 34:SUMMARY OF SAFETY AND EFFECTIVENESS
1.0 USE
1.1 What it is
STAR is a software device that is intended to be used as the ST and Arrhythmia analysis engine in host computing devices. It can be ported to host computing devices that meet STAR specifications.
1.2 What it does
The STAR device provides ST Analysis, Cardiotach Analysis, and Arrhythmia Analysis capability to compatible computing host devices.
1.3 Where Can it be Used
STAR can only be used in prescription host devices that meet the STAR interface and environment specifications.
1.4 Who Uses it on Whom
STAR is intended to be used by clinicians to monitor cardiac function in neonatal, pediatric, or adult patients.
1.5 Who Prescribes it
In the USA, Federal law restricts STAR to sale by or on the order of a physician.
1.6 Where is it Used
It is intended to be used in a professional health care facility.
It is not intended for home use.
2.0 Indications for Use
The indications for use of the STAR ST and Arrhythmia algorithm software device are:
- · Condition: the clinician decides to continuously monitor cardiac arrhythmia and / or ST segment.
- · Part of body or type of tissue interacted with: ECG signal obtained from electrodes attached to the skin of adult, pediatric, and neonatal patients
- · Frequency of use: As prescribed by clinician.
- · Physiological purpose: To gain information for treatment or to rule out causes of symptoms.
- Prescription versus over-the-counter: STAR is a . prescription device
3.0 How it Works
The STAR (ST and Arrhythmia) algorithm is a software engine that analyzes patient ECG's and produces parameters, events and alarms. It is designed so that it is machine (host) independent and can, therefore be used in more than one device. STAR currently operates in the Windows NT, UNIX and a proprietary HP real-time operating system. STAR has a fully specified ECG signal interface, control interface, and output signal interface as well as operating environment specifications as shown in the following STAR Block Diagram.
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STAR BLOCK DIAGRAM FIGURE I:
Image /page/1/Figure/2 description: The image shows a diagram of a host device with a STAR component. The STAR component includes Cardiotach, Arrhythmia, and ST Algorithms. The host device has an input interface, a control interface, and an output interface. The diagram also indicates that the operating environment meets the STAR specification.
In addition to the STAR algorithm, the complete ST and Arrhythmia monitoring application encompasses several aspects: user interaction and control, data management, and alarm presentation and annuciation. That functionality is provided by the host product in which the STAR algorithm is embedded.
4.0 Summary of Major Features
- (1) Arrhythmia analysis and ST segment analysis are "combined" into one software device.
- (2) The common source code of the STAR algorithm can be configured to achieve the appropriate level of functionality and to conform to the operating environment of the device.
- (3) STAR software is written to be independent of the host device with complete specifications of the following:
- · ECG signal input interface,
- · control input interface,
- · output interface,
- · and operating resource requirement.
- (4) STAR algorithm performance is fully validated independent of the final host device.
- (5) QRS detection and arrhythmia analysis on multiple leads of ECG.
5.0 How it Compares to other Devices
STAR is similar to the predicates when operating in the single lead configuration and has improved performance when operating in the multi-lead configuration when compared to single lead devices.
6.0 How was it Verified and Validated
STAR Verification and Validation was a multiphased activity. During early development, tests were created to test logical components, the integration of the logical components and the overall arrhythmia and ST algorithm performance in the STAR off-line development environment. As it became possible to port the STAR algorithm into host environments, additional unit and integration testing was performed within host environments.
The algorithm was first shown to satisfy performance expectations such as accuracy, portability, configurability and efficiency. Then a Final Qualification, Verification, and Validation of STAR was performed by the Algorithm R&D Development Team by repeating White Box, Gray Box, and Black Box tests on STAR. Publicly available data bases used to validate STAR performance included the MIT, AHA, Creighton University, and European Society of Cardiology (ESC) ST-T databases.
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7.0 How we Know it is Safe and Effective When Used as Labeled
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The defined and controlled development processes followed and the documented test results obtained from extensive testing coupled with user documentation of STAR and host devices produces a very high confidence level that the device is safe and effective when used as intended.
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Summary of Safety and Effectiveness 34-4
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