(177 days)
The MARS Unity Workstation is intended to acquire, analyze, edit, review, report and store ambulatory and monitoring network ECG and multiparameter data. The MARS Unity Workstation is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric.
The Heart Rate Variability (HRV) Option is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability heart rate data.
Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The HRV measurements produced by Heart Rate Variability (HRV) Option are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement.
The HRV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.
The Multi-Parameter Analysis and Review System (MARS) unity workstation is an off-the-shelf computer hardware platform that supports a number of software applications including Holter analysis and editing system software and full disclosure clinical review software.
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The Holter analysis software performs acquisition, analysis, editing, review, reporting and storage of ambulatory ECG and multiparameter data acquired from solid-state electronic ECG recorders, tape recorders and the monitoring real-time network.
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The clinical review software (CRS) is a full disclosure system that acquires ECG and mixed parameter waveform data from Marquette's Unity monitoring network for display and reporting.
Heart Rate Variability (HRV) Option is a software option for Marquette Holter analysis systems which measures the variation from one cardiac cycle to the next, utilizing specific morphology. Heart rate variability can be analyzed using either the Time Domain mode, which quantifies variations using simple statistics, or the Spectral mode, which characterizes interval variations as a power spectrum.
The provided text describes the 510(k) summary for the MARS Unity Workstation with Heart Rate Variability (HRV) Option. However, it does not contain the acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Let's break down what information is available and what is missing, based on your requested points:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices rather than defining new performance acceptance criteria for quantitative metrics.
- Reported Device Performance: Not explicitly stated in a quantitative manner. The document concludes that "MARS Unity Workstation with Heart Rate Variability (HRV) Option is as safe, as effective, and performs as well as the predicate devices," based on a "Test Summary" that lists quality assurance measures like risk analysis, requirements reviews, code inspections, and various types of testing, but no specific performance results (e.g., accuracy, sensitivity, specificity) are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
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, as no formal "test set" and "ground truth establishment" study akin to typical AI/diagnostic device validation is described. The focus is on software development and testing rather than clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/mentioned, as no formal "test set" and "ground truth establishment" study is described.
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
- Not performed/mentioned. The device is an "option" for Holter analysis systems focusing on providing HRV measurements. It is explicitly stated that "Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis." This indicates it's a measurement tool, not an AI-assisted diagnostic aid that human readers would "improve with."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a "software option for Marquette Holter analysis systems which measures the variation from one cardiac cycle to the next." It is a standalone algorithm in the sense that it automatically calculates HRV measurements. However, the performance of this algorithm (e.g., accuracy of measurement compared to a gold standard) is not quantitatively reported in this document. The "Test Summary" mentions software testing, but not specific performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly specified. Since the device measures variation and does not diagnose, the ground truth would likely be a reference standard for heart rate variability measurements, but this is not detailed.
8. The sample size for the training set
- Not applicable/specified. This appears to be a rule-based or statistical processing algorithm, not a machine learning model that requires a distinct "training set."
9. How the ground truth for the training set was established
- Not applicable, as there's no mention of a training set for a machine learning model.
Summary of what is present:
The document describes the MARS Unity Workstation with Heart Rate Variability (HRV) Option as a software update/addition to an existing Holter analysis system. Its purpose is to quantify heart rate variability (RR intervals) using Time Domain and Spectral modes.
The "Test Summary" section outlines the quality assurance measures applied during development, serving as the "study" for compliance and performance:
- Risk analysis
- Requirements specification reviews
- Code inspections
- Software and Hardware Testing
- Safety testing
- Environmental testing
- Final validation
The conclusion states that "The results of these measures demonstrate MARS Unity Workstation with Heart Rate Variability (HRV) Option is as safe, as effective, and performs as well as the predicate devices, CENTRA IL Analysis System and Spacelabs Heart Rate Variability Software." This indicates that the predicate devices serve as the de facto "acceptance criteria" for overall safety and effectiveness, meaning the new device needed to perform comparably. However, no specific comparative performance data (e.g., exact agreement rates, correlation coefficients, or specific discrepancies) is provided in this summary.
This 510(k) summary represents a typical submission of its era, focusing on substantial equivalence through comparison to legally marketed predicate devices and robust software development processes, rather than a detailed clinical performance study with quantitative acceptance criteria and results for a novel AI/diagnostic algorithm.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).