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The M5 Recorder is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.

The M5 Recorder is intended for use by adults and all pediatric subgroups (weighing more than 10 Kg).

The M5 Recorder is a small, lightweight ambulatory electrocardiograph (ECG) recorder that records ECG continuously. The M5 records 1 or 3 channels of ECG up to 21 days. The battery duration of the M5 is dependent on the configured settings of sample rate and channel selection. The device is composed of the ECG recorder that can be utilized with a patch electrode or with a patient cable lead set using off the shelf electrodes intended for long-term monitoring. The device snaps onto the patch electrode or patient cable lead set and automatically begins recording. The recording will continue until either the M5 completes the programmed monitoring session, is removed from the Patch Electrode or patient cable, or the battery is depleted.

At the end of the recording, the device can be plugged into a PC via the M5 USB cable. The ECG recording can be transferred to a PC where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The M5 recorder acquires ECG data and does not perform any data processing or arrhythmia analysis of the ECG data. Only the M5 Recorder is part of this 510K application.

During the recording period the patient wears the M5 Recorder with the patch electrode on the upper chest near the sternum. If using the M5 Recorder with the patient cable, the patient will wear off the shelf electrodes (2 - 5) positioned on the torso. The M5 Recorder can be worn continuously up to 14 days with the same patch electrode and up to 4 days with the patient cable and same set of off the shelf electrodes.

The M5 Recorder consists of a microprocessor, measuring circuit, memory, data storage, light emitting diode (LED), and contacts to the electrode. In addition to that, the M5 Recorder contains firmware to control the collection of the ECG data and allows transfer to the processing software. The M5 Recorder has an internal Bluetooth radio that may be utilized with a host ambulatory ECG analysis system (such as the Global Instrumentation M12A application) to allow the qualified health care provider a view of the patient's ECG immediately following hook-up. The LED on the M5 Recorder will flash. This provides visual confirmation to the professional that the recorder is actively collecting data.

The M5 recorder also has a button on the recorder. The primary function of the button is to provide an event feature where the patient presses the button on the recorder when they feel a symptom. The LED will flash to provide feedback to the patient that the event marking has occurred. The button also allows for a battery status check.

The associated spare parts that are part of the M5 Recorder system are the M5 Patch Electrode, M5 Patient Cable, M5 USB Cable, and GI Wall Charger.

The M5 Recorder is an ambulatory ECG recorder. It records 1 or 3 channels of ECG for up to 21 days for the purpose of detecting transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, chest pain, and/or anxiety in adult and pediatric patients (weighing >10 kg).

Here’s a summary of the M5 Recorder's acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative clinical acceptance criteria for the M5 Recorder's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection), as the device itself does not perform arrhythmia analysis. Instead, the performance data focuses on technical compliance with established standards and usability. The acceptance criteria essentially revolves around demonstrating substantial equivalence to predicate devices and meeting relevant safety and performance standards.

2. Sample size used for the test set and the data provenance

The document states that no clinical studies were performed. The "test set" for the M5 Recorder primarily relates to usability testing and bench testing for compliance with standards.

• Usability Testing Test Set:
  • Sample Size: 64 volunteer subjects.
  • Data Provenance: Not explicitly stated regarding country of origin, but implied to be associated with Global Instrumentation LLC (Manlius, NY, USA), so likely U.S. based. The studies were prospective as they were conducted specifically for the M5 Recorder (May 7, 2019, through March 10, 2020).
• Bench Testing: No specific "sample size" of patients/data is applicable here, as these are technical performance tests on the device hardware and software.

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

• Usability Testing: The document mentions "Clinical users participated in the U5 Usability Test. The clinical user group comprised a cross section of experience in using ambulatory ECG recorders and clinical positions representative of the intended M5 Recorder user base." It does not specify a precise number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). However, the implication is that qualified healthcare professionals who would typically use such devices were involved. The ground truth here is successful interaction with the device and its components, as assessed by these clinical users and observation by Global Instrumentation LLC personnel.
• Bench Testing: For compliance with technical standards, the "ground truth" is adherence to the specifications of those standards. This is established through engineering and quality assurance processes, not by external experts adjudicating clinical outcomes.

4. Adjudication method for the test set

• Usability Testing: The text indicates that the usability testing was "implemented and overseen by Global Instrumentation LLC personnel." It states, "The testing was successful in validating the clinical and patient usability of the M5 System based on the usability goals and pass/fail criteria established in each study." This implies an internal adjudication process based on predefined criteria, rather than an expert consensus method like 2+1 or 3+1 that is common in clinical diagnostic accuracy studies.
• Bench Testing: Adjudication is internal, based on meeting the requirements of each standard.

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, an MRMC comparative effectiveness study was not done. The M5 Recorder is a data acquisition device (records ECG data) and does not perform any data processing or arrhythmia analysis. Therefore, there is no AI component in the device itself that would assist human readers, and such a study would not be applicable.

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

No, a standalone algorithm performance study was not done. The M5 Recorder is explicitly stated to "acquire ECG data and does not perform any data processing or arrhythmia analysis of the ECG data." It is a hardware recorder, not an analytical algorithm.

7. The type of ground truth used

• For biocompatibility and mechanical testing, the ground truth is adherence to the specified international and national standards (e.g., ISO 10993, IEC 60601-1).
• For software validation, the ground truth is successful execution against specified requirements, as guided by FDA's guidance for software in medical devices and IEC 62304.
• For usability testing, the ground truth was the ability to meet "usability goals and pass/fail criteria established in each study," validated by participant interaction and observation by personnel.

8. The sample size for the training set

Not applicable. The M5 Recorder is a data acquisition device and does not contain artificial intelligence or machine learning algorithms that would require a "training set."

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

Not applicable. As stated above, there is no training set for this device.

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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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