(9 days)
The Holter Plus ™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.
The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
The Holter Plus™ Ambulatory ECG Analysis System is an ambulatory ECG analysis system comprised of a standard computer display, a standard Personal Computer (PC) based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar RZ153+ data recorder - 510(k) K993618). The Holter Plus™ Ambulatory ECG Analysis System System can provide the retrospective display, storage and recording (or printing) of ambulatory ECG waveform and annotated data that is provided by the Braemar RZ153+ recorder.
The Holter Plus™ Ambulatory ECG Analysis System allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing. This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies, and allow the results to be printed if desired. The Holter Plus TM does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data such as heart rate trends and RR variability in graphical form. The physician will be able to review, edit, and print the data collected. The Holter Plus™ will provide information such as when patient-activated events occurred.
The Holter Plus™ Ambulatory ECG Analysis System provides storage of patient data for archiving and printing various reports. This includes waveform and patient parameter data for the ambulatory ECG data and assessment. The waveform and parameter data that has been stored in a patient file can be retrieved and reviewed on the display or printed out on a laser printer.
The Holter Plus™ Ambulatory ECG Analysis System received 510(k) clearance based on its substantial equivalence to several predicate devices. The submission indicates that performance testing was conducted to demonstrate this equivalence. However, the provided document does not contain a detailed table of acceptance criteria or specific reported device performance metrics in numerical form.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed above has been performed, and these results show similar performance with these devices."
However, it does not provide a quantitative table of acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for specific arrhythmia detection) or the specific numerical performance results achieved by the Holter Plus™ system. The claim is based on a general "similar performance" to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. There is no mention of the number of cases or patients used in any test set, nor is there any indication of the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. There is no mention of experts involved in establishing ground truth for any test set or their qualifications.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not mentioned in the document. The submission focuses on device equivalence, not on the improvement of human readers with AI assistance. The device's role is described as analysis and display for a clinician's review and editing, but not as an AI-assisted diagnostic tool in the sense of improving human reader performance directly.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
The description implies standalone performance in terms of its analysis capabilities: "This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies..." However, the document does not provide specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for these classifications. The output is referred to as "analysis for the clinician's review and editing," emphasizing human oversight for diagnosis.
7. Type of Ground Truth Used:
This information is not explicitly stated in the document. Given the nature of Holter monitoring and the "review, edit, and print" functionality for clinicians, it's highly probable that expert review and adjudication (human expert consensus) of the ECG waveforms would form the basis of a "ground truth" if one were established for performance testing. However, this is an inference, not a direct statement.
8. Sample Size for the Training Set:
This information is not provided in the document. The document describes the system's capabilities but does not detail its development process in terms of machine learning training, thus no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document for the reasons stated in point 8.
§ 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).