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The MAC 5 Resting ECG Analysis System is a non-invasive prescription device.
• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
• The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.
The device can capture 3, 6, or 12 lead electrocardiograms, provide interpretive analysis, and print reports.
The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.
The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.

The provided text is a 510(k) summary for the GE MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System. It focuses on demonstrating substantial equivalence to a predicate device (MAC 7 Resting ECG Analysis System) and a reference device (ELI 380 - 12 Lead Resting ECG). The documentation does not contain specific acceptance criteria and performance data for the device's diagnostic capabilities, nor does it detail a study proving the device meets particular acceptance criteria related to its interpretive analysis.

The document primarily focuses on explaining that the device is substantially equivalent to existing devices based on technical specifications, intended use, indications for use, and a comparison of features. It explicitly states, "The subject of this premarket submission, MAC 5 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I describe a study that proves the device meets those criteria, as such information related to diagnostic performance is not present.

However, I can extract information related to the device's characteristics and the comparison to predicate/reference devices:

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

The document does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy for disease detection) for the interpretive ECG analysis, nor does it report the device's performance against such criteria. The "performance" discussed is in terms of feature functionality and technical specifications being "substantially equivalent" to predicate devices.

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

This information is not provided in the document. The submission states that clinical studies were not required to support substantial equivalence.

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)

This information is not provided. Since no clinical studies were deemed necessary, there is no mention of a test set with expert-established ground truth.

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

This information is not provided.

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 mentioned. The submission states that clinical studies were not required. The device provides "interpretation of the data for consideration by a physician" and "is not intended as a sole means of diagnosis," indicating it's an assistive tool, but no study validating its impact on human reader performance is presented here.

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

No standalone performance study of the interpretive algorithm (12SLTM analysis algorithm v24) is detailed in this document. The focus is on the substantial equivalence of the overall system.

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

This information is not provided.

8. The sample size for the training set

The document does not provide information about the training set for the 12SLTM analysis algorithm. It only mentions that the proposed device uses "12SLTM analysis algorithm (v24)" (which is an updated version of the algorithm used in the predicate device, v23.1). It states "No changes to the interpretive statements of the 12SLTM analysis algorithm (v24) under K141963 and compared to the predicate device. The changes introduced with the 12SLTM (v24) do not impact the ECG analysis (measurement or accuracy) of the algorithm." This suggests the algorithm itself has been previously validated, but details are not in this document.

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

This information is not provided in this document.

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The XScribe/Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician.

The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment.

The device is not intended to be used as a vital signs physiological monitor.

The XScribe / Q-Stress device is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules. The device is able to generate risk scoring via recognized protocols. The device is capable of obtaining a resting ECG with automatic interpretation. The device can interface with equipment for pulmonary evaluation. The device has several built in exercise protocols for connection and control of exercise equipment such as treadmills and ergometers. The device supports measurement of non-invasive blood pressure. The device can output analog ECG signals or digital QRS trigger signals for synchronizing an external device. The device supports a touch screen interface as well as a keyboard / mouse interface and a wired remote control unit. The device will store a complete record of diagnostic quality test data from which the user can generate and review stress test reports. The device can function as standalone workstation or can connect via network to a database server allowing for remote review capabilities. The device can communicate with electronic record keeping systems to obtain work lists and patient data, and to provide test result reports.

This document is a 510(k) premarket notification for the Mortara Instrument, Inc. XScribe and Q-Stress Stress Exercise Testing Systems. It asserts substantial equivalence to a predicate device, XScribe II (K022618).

The crucial point for the request is that this submission explicitly states that clinical data was NOT required or used to support substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, test set details (sample size, provenance, ground truth experts, adjudication), MRMC studies, standalone performance, or training set details because no such studies were performed or are presented in this document for the purpose of demonstrating substantial equivalence.

The document primarily relies on non-clinical data, software verification and validation, and compliance with applicable electrical and medical device standards to establish substantial equivalence.

Here's how I can address the prompts based on the provided text:

Acceptance Criteria and Study for DEVICE PERFORMANCE (Based on Available Information):

Since no clinical study data is provided in this 510(k) submission to demonstrate the device meeting performance acceptance criteria in a clinical setting against a ground truth, the "acceptance criteria" here refer to the engineering and regulatory compliance criteria used for a 510(k) submission based on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable / Not Provided for Clinical Performance. The submission explicitly states: "The subject of this premarket notification did not require clinical data to support substantial equivalence."
• For the non-clinical software and hardware testing, the specific sample sizes or data provenance (e.g., number of test cases, simulated data characteristics) are not detailed in this summary. These would typically be found in the full testing reports which are not part of this public summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable / Not Provided. As no clinical performance study was conducted or presented to establish ground truth for clinical outcomes, no such experts were involved for this purpose in this submission.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided. No clinical performance study requiring adjudication was presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states that clinical data was not required or utilized for this submission. Therefore, no MRMC study was conducted.

6. If a Standalone (algorithm only without human-in-the-loop) performance was done:

• Not Applicable / Not Provided as a distinct clinical study. The device "acquires, processes, records, archives, and outputs electrocardiographic data" and performs "ST analysis and ventricular ectopic beat detection." While these are algorithmic functions, their standalone performance in a clinical diagnostic context (e.g., sensitivity/specificity for detecting certain conditions) is not quantified or presented in this 510(k) submission through a dedicated study with clinical ground truth. The V&V activities would assess the technical correctness of these algorithms.

7. The Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" would be the engineering specifications, regulatory standards, and expected behavior of the software and hardware components. This is not clinical ground truth (e.g., pathology reports, expert consensus on patient diagnosis).
• For clinical performance, no ground truth was established or used, as no clinical study was performed.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. This device is largely based on known physiological principles and signal processing, and it is asserting substantial equivalence to an existing predicate. The nature of this 510(k) (not a novel AI/ML device relying on extensive data training for a diagnostic claim) means that a "training set" in the context of machine learning model development is not relevant or disclosed here. Its processing capabilities are likely rule-based or parametrically driven from established algorithms.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Not Provided. See point 8.

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