(91 days)
The M12 Matrix Holter System is intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods up to 48-hours. The Matrix Holter System is intended for use under the supervision of a Physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.
This procedure is commonly called a Holter procedure which captures ECG rhythm abnormalities which may be infrequent or provoked by activities outside of the physician office.
The M12 Matrix Holter System is comprised of the Matrix Holter Recorder (M12R) and the Matrix Holter System Application (M12A).
The Matrix Holter Recorder component of the system will be worn by the patient and is used to record ambulatory electrocardiograph data from the patient. The Matrix Holter System Application is used to analyze the data recorded by the Matrix Holter Recorder.
The subject Devices will provide the following diagnostic functions:
- Acquiring, viewing, storing and printing ambulatory ECG waveforms from . patients using the Matrix Holter Recorder and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
- Using optional Holter algorithms to generate measurements, data presentations . and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
- Using optional interpretive algorithms to generate measurements, data . presentations, graphical presentations, and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
The M12 Matrix Holter System is a Holter system consisting of the Matrix Holter recorder (M12R) and the PC-based Matrix Holter System Application (M12A). The complete system is referred to as the M12 Matrix Holter System.
The Matrix recorder is a Holter Recorder (ambulatory electrocardiograph) designed to be used with the PC-based Matrix Holter System Application. The Matrix recorder acquires ECG data, converts the data to digital format and stores the digital data. The data is not analyzed by the Matrix recorder. The Matrix recorder uses a 7 or 10 lead electrode hookup and placement to obtain data for use by the Matrix Holter System Application. The Matrix Holter System Application is a PC-based application which is used to analyze, view, print, and edit the data collected by the Matrix recorder. The ambulatory electrocardiograph data recorded by the Matrix recorder is transferred to the Holter System Application, where it is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.
The Matrix Holter recorder acquires up to 12 leads of ECG data continuously for a period of up to 48 hours. The data is stored in digital format and is intended to be retrieved from the recorder by the Matrix Holter System Application for data review and analysis.
The Matrix Holter recorder contains a keypad to provide means to configure the recorder, check hookup lead quality, and start the recording. The patient can use the keypad to enter patient activated event marks into the recording.
The Matrix recorder has a display which provides operational status information to the hook-up technician and to the patient. This information includes hook-up lead quality and system status.
The Matrix recorder uses two AA batteries for power supply. Data is stored on a removable memory card. The data is transferred from the Matrix recorder to the Matrix Holter System Application by removing the memory card from the recorder and inserting the card into the memory card interface of the PC running the application. An optional wireless communication interface can also be used to transfer data from the recorder to the Matrix Holter System Application.
The Matrix Holter System Application is a PC-based application. This application runs on a conventional PC system with a processing/data storage module, a graphical color display, a user interface keyboard, a printer, memory card interface and communication interfaces.
The provided document does not contain a study explicitly detailing acceptance criteria and device performance in the format requested. The document is a 510(k) premarket notification summary for the Matrix Holter System, which generally focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria.
However, based on the information provided, I can infer some aspects that would typically be part of such a study for a cardiovascular device like a Holter system.
Here's an attempt to answer your request based on the available information, noting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state quantitative acceptance criteria or a reported device performance table. For a Holter system, acceptance criteria would typically revolve around the accuracy of arrhythmia detection and morphological classification compared to a gold standard. Since the submission is for substantial equivalence, the implicit "acceptance criteria" is that the device performs comparably to the predicate devices.
Inferred/Typical Performance Metrics for Holter Systems:
| Performance Metric (Inferred) | Acceptance Criteria (Missing/Implied) | Reported Device Performance (Missing/Implied) |
|---|---|---|
| Arrhythmia Detection Accuracy (e.g., Sensitivity, Specificity for beats, rhythms like AFib, PVCs, pauses) | Performance comparable to predicate devices (K004017, K945985) | Not explicitly reported in the document. |
| ECG Waveform Quality | Capable of acquiring and storing diagnostic quality ECG waveforms | Stated to acquire up to 12 leads of ECG data continuously for up to 48 hours. |
| Data Transfer Reliability | Reliable transfer of recorded data | Data stored on a removable memory card or via optional wireless communication. |
| Ease of Use/Functionality | Basic functionalities of a Holter system (recording, viewing, printing, analysis) | Described features include acquiring, viewing, storing, printing, and optional algorithm analysis. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or the provenance of any data used for performance claims. 510(k) submissions often rely on substantial equivalence and verification testing (e.g., bench testing, limited clinical data) rather than large-scale clinical trials with defined test sets.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information on the number of experts, their qualifications, or their involvement in establishing ground truth for any test data. For Holter systems, ground truth for arrhythmia detection is typically established by expert cardiologists reviewing full-disclosure ECG recordings.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. MRMC studies are typically used to assess the impact of AI on human reader performance, which doesn't appear to be the primary focus of this 2005 510(k) submission for a traditional Holter system with "optional algorithms."
6. Standalone (Algorithm Only) Performance Study
The document does not explicitly detail a standalone performance study for its "optional algorithms." It states these algorithms "generate measurements, data presentations, and graphical presentations on an advisory basis for patients," to be reviewed and interpreted by a clinician. This implies human-in-the-loop operation, rather than a standalone algorithm making definitive diagnoses. Although performance studies for algorithms are usually included in 510(k) for devices with "analysis algorithms," specific details are absent here.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing. For Holter analysis algorithms, ground truth is typically derived from expert consensus review of the ECG waveforms.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is consistent with a 2005 submission for a device where advanced machine learning or deep learning (which require large training sets) might not have been the primary technology for the "optional algorithms." These algorithms could be rule-based or employ classical signal processing techniques.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth for any training set was established.
Summary of Missing Information:
The provided 510(k) summary focuses on the device description, intended use, and substantial equivalence to predicate devices. It lacks specific details regarding performance studies, acceptance criteria, sample sizes, expert involvement, or ground truth methodologies that would typically be found in a detailed study report for an AI/ML-driven device or even a conventional device with specified performance claims beyond substantial equivalence. This is common for 510(k) submissions, where comparison to existing devices often suffices.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).