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510(k) Data Aggregation
(121 days)
MARS HOLTER ANALYSIS WORKSTATION
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG and multi-parameter 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 used 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 Hotter Analysis Workstation analyzes 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 and multi-parameter data from the CIC Pro Clinical Information Center. A variety of different final report formats can be stored and printed. The final report is used by trained medical personal to diagnose a patient's cardiac abnormalities.
This submission concerns the GE MARS Holter Analysis Workstation, an ECG analysis software system. The device did not require clinical studies, as it was determined to be substantially equivalent to a predicate device (MARS Holter Analysis Workstation K#093141). Therefore, there is no information about specific acceptance criteria or related studies as you would typically find for a new device requiring clinical validation.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
No specific performance acceptance criteria or reported device performance values were listed in the provided document. The submission states that the device is "as safe, as effective, and performance is substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance
Not applicable, as no clinical studies with a test set were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical studies with a test set were conducted.
4. Adjudication method for the test set
Not applicable, as no clinical studies with a test set were conducted.
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 applicable. The device is a software system intended to assist physicians in interpretation, not to replace it, and no MRMC study was mentioned. The submission explicitly states: "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."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document does not explicitly describe a standalone algorithm performance study. However, the mention of "Performance testing (Verification)" and adherence to standards like AAMI EC-57:1998 (R2008) "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms" suggests that the algorithm's performance was evaluated internally, likely in a standalone manner against established benchmarks or annotated datasets. Specific results are not provided in this summary.
7. The type of ground truth used
For any internal performance testing (referring to adherence to AAMI EC-57), the ground truth would typically be established by expert consensus or meticulously annotated datasets designed for such algorithmic testing. However, the document does not specify the exact type of ground truth used for such internal verifications.
8. The sample size for the training set
Not applicable. The document does not provide details about a training set, as it emphasizes substantial equivalence to a predicate device and does not describe the development or validation of a new AI model in detail.
9. How the ground truth for the training set was established
Not applicable, as no training set details are provided.
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(85 days)
MARS HOLTER ANALYSIS WORKSTATION
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG and multi-parameter 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 used 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 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 and multi-parameter data from the CIC Pro Clinical Information Center. A variety of different final report formats can be stored and printed. The final report is used by trained medical personal to diagnose a patient's cardiac abnormalities.
The provided documentation indicates that the MARS Holter Analysis Workstation did not require clinical studies to support substantial equivalence. Therefore, there is no detailed information on acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert qualifications, or other clinical study specifics as requested.
The submission states:
"The subject of this premarket submission, MARS Holter Analysis Workstation, did not require clinical studies to support substantial equivalence."
Instead of clinical studies, the submission relies on non-clinical tests and compliance with voluntary standards and quality assurance measures during development. These measures include:
- Requirement Definition
- Risk Analysis
- Technical Review
- Formal Design Review
- Code Inspection
- Integration testing (Module and System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
Since no clinical study was conducted as part of this submission, the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment from a clinical trial perspective cannot be provided. The device was deemed substantially equivalent to predicate devices based on its fundamental scientific technology and non-clinical testing.
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(88 days)
MARS HOLTER ANALYSIS WORKSTATION
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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