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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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CardioSoft/CASE Cardiac Testing System is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CardioSoft/CASE Cardiac Testing System is designed to acquire process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of CardioSoft/CASE Cardiac Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
CardioSoft/CASE Cardiac Testing System provides the control of external device (typically a treadmill or Ergometer) and communicates with centralized electronic/digital storage system via network. CardioSoft/CASE Cardiac Testing System provides a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available.
CardioSoft/CASE Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data.
CardioSoft/CASE Cardiac Testing System is intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.
CardioSoft/CASE Cardiac Testing System offers no diagnostic opinion to the user. Instead it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.
CardioSoft/CASE Cardiac Testing System is not intended to be used as a transport device or for home use. CardioSoft/CASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.

The CardioSoft/CASE Cardiac Testing System is designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft will be offered as a software only package including a front end for data acquisition.
The CASE is a turnkey product utilizing the CardioSoft software. The CASE device is designed for the US markets. A version designed for the European market, the CardioSys, will not be offered for sale in the US.

The CardioSoft/CASE Cardiac Testing System is described as substantially equivalent to predicate devices based on safety and performance, but specific acceptance criteria and detailed device performance metrics are not explicitly provided in the furnished text.

Here's an breakdown of the information that can be extracted, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

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

This information is not available in the provided text.

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

This information is not available in the provided text.

4. Adjudication method for the test set:

This information is not available in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

This information is not available in the provided text.

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

The device is an "ECG Analysis Computer" and provides "interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion." It also has "arrhythmia detection provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms." This suggests a standalone component (the algorithm/software) is present, but a formal standalone study proving its performance in isolation is not detailed or explicitly stated. The overall statement is that the system is as safe and effective as the predicate.

7. The type of ground truth used:

This information is not available in the provided text. The submission refers to a "Test Summary" but does not elaborate on the ground truth used for performance evaluation.

8. The sample size for the training set:

This information is not available in the provided text.

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

This information is not available in the provided text. The document outlines "quality assurance measures" such as "Requirements specification review," "Code inspections," "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation," but these do not detail how ground truth was established for any training data.

Summary of the Study Discussed (as per the available text):

The document references a "Test Summary" that states, "The CardioSoft/CASE Cardiac Testing System complies with the voluntary standards as detailed in Section 9 of this submission." It further states, "The following quality assurance measures were applied to the development of the system: Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation."

The conclusion from these "measurements" (which are not detailed) is that "The results of these measurements demonstrated that the CardioSoft/CASE Cardiac Testing System is as safe, as effective, and performs as well as the predicate device."

Key Take away: This 510(k) summary focuses on demonstrating substantial equivalence through a general assertion of safety and effectiveness compared to predicate devices, supported by a list of quality assurance measures. It does not provide the granular detail typically found in a clinical study report regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or ground truth methodologies. This type of submission relies more on demonstrating that the new device uses similar technology, has similar intended use, and has undergone standard development and testing procedures to ensure it is "as safe, as effective, and performs as well" as previously cleared devices.

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