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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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