(121 days)
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.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).