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The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediation populations. Dasio systems don't display, and record clock. Sie and all gr 3, 6, 12, or 15 lead ECG's, 12 lead can be upgraded to provide merpretive analysis, vootor loops, and resolution signal averaging of Sollware analysis options of the electrocardiogram. Transmission and QRS and I wave portions of and from a central ECG cardiovascular information system is optional.
The MAC 5000 is intended to be used under the direct supervision of a The MAC 5000 is michaou to be be as a loss and a hospital or medical professional's facility.

The MAC 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The system consists of two basic components: the processing unit and the patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.
The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC 5000 system acquires ECG data using a modular patient data acquisition device called the CAM14 (K991735). By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5000 delivers 12 or 15 lead ECG's on fullsize reports with alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, integrated thermal writer and removable data storage.
Additionally, the MAC 5000 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.

The provided document (K042177) is a 510(k) summary for the GE MAC 5000 ECG Analysis System. It states that the device is substantially equivalent to predicate devices but does not contain specific acceptance criteria, performance data, or details of a study proving the device meets acceptance criteria.

The 510(k) summary mentions "Test Summary" and lists various types of testing performed (Risk Analysis, Technical Reviews, Design Reviews, Code Inspections, Unit level Testing, Integration Testing, Final Acceptance Testing, Performance Testing, Safety Testing). However, it explicitly states: "The results of these measurements demonstrated that the MAC 5000 is as safe, as effective, and performs as well as the predicate devices." This is a general statement of equivalency, not a presentation of specific acceptance criteria or quantitative performance data.

Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them, along with the specified details, because this information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for the new device.

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The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment. The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5000 system acquires ECG data using a modular patient data acquisition device called the CAM14 (K991735). By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5000 delivers 12 or 15 lead ECG's on full-size reports with alphanumeric keyboard for patient demographic and other data entry, a full-size VGA graphics and waveform display, integrated thermal writer and removable data storage. Additionally, the MAC 5000 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.

The provided document K033492 is a 510(k) summary for the MAC 5000 ECG Analysis System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The submission states that the "results of these measurements demonstrate that the MAC 5000 is as safe, effective, and performs as well as the predicate device," but it does not provide the specific measurements or the acceptance criteria used for that determination.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not Available. The document does not provide a table of acceptance criteria or specific reported device performance metrics in numerical form. It states that the device "performs as well as the predicate device" but does not quantify this performance.

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

Not Available. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Final system validation" but does not disclose the sample size of any test sets (e.g., number of ECGs or patients) or the provenance of the data used for these tests.

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)

Not Available. The document does not describe how ground truth was established for any testing, nor does it mention the involvement or qualifications of experts for this purpose.

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

Not Available. The document does not mention any adjudication method for a 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

Not Available. The document does not describe an MRMC study or any study involving human readers with or without AI assistance. The device is an ECG analysis system, which typically provides automated interpretations, and the focus of the submission is on its equivalence to a prior automated system.

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

Likely Yes, but details are not provided. The submission focuses on the "ECG Analysis System" and specifically mentions that "All algorithms have been previously cleared and include: ECG Analysis Program 12SL (K002209) Phi Res Algorithm (K972199)". This implies that the algorithms function in a standalone capacity to provide interpretations. However, the document does not present separate standalone performance metrics or a study specifically detailing this. The "Test Summary" mentions "Software and hardware testing" and "Final system validation," which would implicitly include standalone algorithm performance, but no results are given.

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

Not Available. The document does not specify the type of ground truth used for any testing or validation.

8. The sample size for the training set

Not Available. The document does not provide any information about the training set size for the ECG analysis algorithms. It mentions that previously cleared algorithms (12SL and Phi Res) are utilized, but details about their training are not in this submission.

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

Not Available. Similar to the above, the document references previously cleared algorithms but does not disclose how their training set ground truth was established.

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The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems electrocatulographic information from lead. and potitution playsis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of upgraded to provide somnary of the electrocardiogram. Transmission and reception of ECG QRO and from a central ECG cardiovascular information system is optional.

The MAC 5000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.

The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The provided document for K014108 for the GE Medical Systems MAC 5000 ECG Analysis System is a 510(k) summary and FDA clearance letter, not a detailed study report. Therefore, it does not contain the specific information required to complete all sections of your request.

Here's what can be extracted and what is not available:

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

This information is not provided in the document. The 510(k) summary states that "Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness" and "The MAC 5000 complies with the voluntary standards as detailed in Section 9 of this submission," but it does not present specific acceptance criteria or performance metrics.

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.

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 in the document.

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

This information is not provided in the document.

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

An MRMC study is not mentioned and likely not applicable in this context as the device is for automated ECG analysis, not AI-assisted human reading. The document focuses on the device's own analytical capabilities.

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

Yes, the device is described as an "ECG Analysis System" that "acquire[s], analyze[s], display[s], and record[s] ECG signals." This implies standalone algorithm performance as its primary function. However, specific standalone performance metrics are not provided.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of available information:

The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting detailed clinical performance study data with acceptance criteria or ground truth establishment. While it mentions internal quality assurance measures (Requirements specification reviews, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final system validation), these are development process descriptions, not performance study results.

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