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The Matrix Data Management System software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiological signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various disease and or treatment regimens. The Matrix Data Management System software also provides non-diagnostic functions such as patient management, data security, search tools for patient. and/or test records and support for exporting data to Electronic Medical Record systems.

The Matrix Data Management System and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below.

-- Ambulatory Blood Pressure Monitor Indication For Use-

The Oscar 2, system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

Optionally, Oscar 2 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff.

It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits (excludes pediatic subjects).

-- Matrix Holter System Indication For Use-

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 (Ml2A).

The Matrix Holter Recorder component of the system will be worn by the patient and is used to record anbulatory 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 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, 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 results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.

--- Matrix Mini ECG Monitor Indication for Use-

The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tibrillation in general medical and surgical floors. general hospital and professional healthcare facilities. The system is indicated for use in pediatric and adult patients.

The Matrix Data Management System is intended for use by clinicians for managing sensor data of pediatric and adult patients in health care facilities.

The Matrix Data Management System (DMS) provides functionality to manage data acquired from various physiologic data acquisition sensors. The DMS supports a mechanism to initialize sensors, acquire data from the sensors and provide summaries of the results obtained from the sensors.

The current sensors supported by the Matrix Data Management System include Ambulatory blood pressure monitoring with optional sensors for Ambulatory ECG and Patient Monitoring.

The Ambulatory blood pressure monitoring sensor used within DMS is approved as Oscar 2 (K151520).

The Ambulatory ECG Monitoring sensor used within the DMS is approved as Matrix Holter System, Model M12 (K051730).

The Patient Monitoring sensor used within the DMS is approved as Matrix Mini ECG Monitor (K152701)

This document is a 510(k) premarket notification for the Matrix Data Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Welch Allyn CardioPerfect Workstation) through technological characteristics and non-clinical testing, rather than presenting clinical study data for device performance against specific acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria for device performance and a study proving the device meets those criteria cannot be extracted from this document, as the submission explicitly states:

• "No clinical studies were utilized for the purpose of obtaining safety and/or efficacy data for this device or the predicate device." (Page 7)
• "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." (Page 7)

The approval is based on non-clinical tests (electrical safety, software lifecycle, risk management) and the similarity to an already approved predicate device.

However, I can provide the information that is available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for device performance based on clinical outcomes or accuracy, as no clinical studies were conducted for this purpose. The device's performance is gauged through non-clinical verification and validation against established standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable/not stated, as no clinical studies were performed measuring human or patient data. The "test set" here refers to non-clinical verification and validation.
• Data provenance: Not applicable, as no clinical patient data was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided as no clinical studies requiring expert ground truth establishment were conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not provided as no clinical studies requiring adjudication 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

• No MRMC comparative effectiveness study was done, as explicitly stated, "No clinical studies were utilized for the purpose of obtaining safety and/or efficacy data for this device." The device is a data management system, not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This concept is not directly applicable. The device is a data management system for physiological signals. Its "performance" is related to its ability to acquire, store, process, and display data from other approved sensors (like Oscar 2 for ABPM, Matrix Holter System, and Matrix Mini ECG Monitor). The approval is based on its substantial equivalence to a predicate device and adherence to non-clinical standards for software and electrical safety. There's no "algorithm-only" performance in the diagnostic sense that would be independently evaluated for accuracy against ground truth in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" would be established specifications and compliance requirements of the standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management, IEC 62304 for software lifecycle processes). There is no clinical ground truth (expert consensus, pathology, outcomes data) used as no clinical studies were performed for efficacy.

8. The sample size for the training set

• Not applicable, as no machine learning/AI model requiring a training set is discussed or evaluated in this submission in the context of diagnostic performance.

9. How the ground truth for the training set was established

• Not applicable, as no machine learning/AI model requiring a training set is discussed or evaluated.

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The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and alternate professional healthcare environments. The system is indicated for use in pediatric and adult patients.

The Matrix Mini ECG Monitor system provides a cardiac monitor which monitors ECG derived heart rate, ECG electrode impedance respiration rate, and specific ECG arrhythmias (including asystole, ventricular tachycardia, and ventricular fibrillation). The Matrix Mini ECG Monitor system consists of a display module, a data acquisition module and an ECG patient cable.

The display module and the data acquisition module are connected together with a USB interface. The data acquisition module is connected to the patient with the ECG patient cable, which is attached to standard ECG electrodes applied to the patient's skin surface.

The display module consists of a tablet computer which provides the graphical display, user interface, data processing, data reporting/review, data communication, alarm, and data storage functions. The data acquisition module provides the patient electrical isolation, interface to ECG skin surface electrodes attached to patient, conversion of analog ECG electrode data to digital data, data processing, and data communication functions. An accessory ECG patient cable is provided to connect the data acquisitions module to standard skin surface ECG electrodes. The accessory ECG patient cables are available in 3 or 5 ECG lead configurations.

The Matrix Mini ECG Monitor provides an ECG heart rate monitor that includes software capable of limited ECG analysis and ECG electrode impedance respiration rate measurement. The Matrix Mini ECG monitor includes the basic functions of the 3 or 5 lead ECG monitoring system hardware standard to a Cardiac Monitor including a Cardiotachometer and rate alarm (product code DRT). The primary predicate device is a cardiac monitor and has a product code of DRT and also provides functions for ECG electrode impedance respiration rate measurement (product code BZQ).

The Matrix Mini ECG Monitor device software can report asystole, ventricular tachycardia and ventricular fibrillation, which may be thought of as arrhythmias, we selected a supplemental predicate device (K120774) with the product code DSI. Both the software device component and hardware components are presented below compared to the currently marketed predicate devices.

The Matrix Mini ECG Monitor uses software to process and display the ECG electrode derived cardiac information to the user. The analog ECG electrode data is acquired and converted to digital data using conventional, well proven, and widely used, electronic digital data acquisition technology. The technology has operational and performance characteristics that comply with IEC 60601-2-27:2011, "Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment". The asystole, ventricular tachycardia and ventricular fibrillation algorithms use conventional software ECG analysis techniques and have been evaluated using ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms"

The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and professional healthcare environments, in pediatric and adult patients.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set or the data provenance. It refers to the use of ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms" for evaluating the arrhythmia algorithms. This standard typically involves testing against standardized arrhythmia databases, but the specific details of the test set used (e.g., its size, origin, and whether it was retrospective or prospective) are not provided in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not specify the number of experts or their qualifications for establishing the ground truth of any test sets. The mention of ANSI/AAMI EC57:2012 suggests that ground truth would likely be established based on accepted labeled arrhythmia databases, but no details are given regarding expert involvement in this specific context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for the test set.

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

No MRMC comparative effectiveness study was done. The submission states, "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." This indicates that no studies involving human readers, with or without AI assistance, were performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, standalone performance testing was conducted. The document states that the asystole, ventricular tachycardia, and ventricular fibrillation algorithms use conventional software ECG analysis techniques and "have been evaluated using ANSI/AAMI EC57:2012 'Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms'". This standard is for evaluating the performance of the algorithms themselves, without human readers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the reference to ANSI/AAMI EC57:2012, the ground truth for the arrhythmia detection algorithms would likely be derived from a standardized arrhythmia database, which typically uses expert-annotated ECG recordings, forming a type of expert consensus ground truth. However, the document does not explicitly state the type of ground truth used for this specific evaluation.

8. The sample size for the training set

The document does not specify the sample size for the training set of the algorithms.

9. How the ground truth for the training set was established

The document does not specify how the ground truth for the training set was established.

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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:

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.

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