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510(k) Data Aggregation
(88 days)
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and holter analysis capabilities.
Data acquired may be use for the following indications:
- Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances
- Evaluation of symptoms that may be due to myocardial ischemia
- Detection of ECG events that alter prognosis in certain forms of heart disease
- Detection and analysis of pacemaker function and failure
- Determination of cardiac response to lifestyle
- Evaluation of therapeutic interventions
- Investigations in epidemiology and clinical trials
The MARS Holter Analysis Workstation system is a software-system that runs on PC based hardware. The MARS Holter Analysis Workstation supports a number of software applications including analysis, user editing and final report processing.
The MARS Holter Analysis Workstation analyzes ambulatory ECG data, to detect and label beats, and then presents it in a variety of screens to the user for review and data editing purposes. The MARS Holter Analysis Workstation system stores and prints final reports and allows reports to be sent to the MUSE Cardiology Information Management System for long- term archive. The MARS Holter Analysis Workstation supports acquisition from ambulatory ECG Recorders. A variety of different final report formats can be stored and printed. The final report is used by trained medical personal to diagnosis a patient's cardiac abnormalities.
Here's an analysis of the provided text regarding the MARS Holter Analysis Workstation's acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state specific numerical acceptance criteria for the MARS Holter Analysis Workstation. Instead, it relies on a statement of substantial equivalence to predicate devices and adherence to voluntary standards and quality assurance measures.
Therefore, the table will reflect this qualitative approach.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Overall Safety and Effectiveness: Device should be as safe and effective as predicate devices. | "The results of these measurements demonstrated that the MARS Holter Analysis Workstation is as safe, as effective, and performs as well as the predicate devices." (Predicate devices: K991786 GEMS-IT MARS Unity Workstation, K010949 Agilent Technologies 2010 Plus Holter for Windows). |
| Compliance with Voluntary Standards: Device should comply with relevant voluntary standards. | "The MARS complies with the voluntary standards as detailed in Section 9 of this submission." (Specific standards not detailed in this extract). |
| Quality Assurance Measures: Development should adhere to established quality assurance processes. | "The following quality assurance measures were applied to the development of the device:Requirements specification reviewRisk analysisSoftware and hardware testingPerformance testingSafety testingEnvironmental testingClinical use evaluationFinal validation" |
| Functional Equivalence: Device should employ the same technology and functionality as predicate devices. | "The proposed MARS Holter Analysis Workstation employs the same functional scientific technology as the predicate devices MARS Unity (K991786) and 2010 Plus Holter for Windows (K010949)." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for a distinct "test set." The document mentions "clinical use evaluation" as a quality assurance measure, but no details of such a study are provided. The "results of these measurements" (referring to the quality assurance measures) form the basis for the conclusion that the device performs as well as predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The provided text does not specify the number or qualifications of experts used to establish ground truth for any test set. While the intended use states that "Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data" and "This information is not intended to serve as a substitute for the physician overread of the recorded ECG data," it doesn't detail how this physician overread was used in a testing context.
4. Adjudication Method for the Test Set:
The provided text does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it mention any effect size related to human reader improvement with or without AI assistance. The focus is on the device's standalone performance compared to predicate devices, with the understanding that a trained operator and physician will be supervising and interpreting the results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was effectively done. The document states that the MARS Holter Analysis Workstation "analyzes ambulatory ECG data, to detect and label beats, and then presents it in a variety of screens to the user." The "results of these measurements demonstrated that the MARS Holter Analysis Workstation is as safe, as effective, and performs as well as the predicate devices." This implies that the algorithm's performance in analyzing ECG data was evaluated independently as part of the "performance testing" and "final validation" phases mentioned in the quality assurance measures. The focus is on the system's ability to perform the analysis, even though the output is for physician review.
7. The Type of Ground Truth Used:
The provided text does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of Holter analysis and the reliance on predicate devices, it's highly probable that ground truth would involve:
- Established interpretations by qualified cardiologists/electrophysiologists from previously analyzed Holter recordings.
- Comparison against outputs of the predicate devices which themselves would have been validated against expert interpretation or established clinical standards.
8. The Sample Size for the Training Set:
The provided text does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set was Established:
The provided text does not explicitly state how the ground truth for the training set was established.
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