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The MAC™ 2000 ECG analysis system is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional's facility, clinics, physician`s office or outreach centers.

NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years.

The MACTM 2000 ECG analysis system provides the following modes of operation:

• Resting ECG mode .
• . Arrhythmia mode
• Exercise mode for exercise stress testing (optional) .
• RR analysis mode for RR interval analysis (optional) .

The basic system prints 6 or 12 leads of ECG and is upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Arrhythmia detection is provided for the convenience of automatic documentation.

Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The MACTM 2000 ECG analysis system can print and display multiple leads of ECG data. The device is capable of acquiring 2 additional ECG leads beyond what is needed for classical 12 lead ECG acquisition.

The MACTM 2000 ECG analysis system provides ECG measurement in both resting and stress mode. The device also supports arrhythmia as a mode of operation.

The Hook up advisor feature in MAC™ 2000 ECG analysis system advises the users of poor lead quality based on noise measurement.

The MACT14 2000 ECG Analysis System delivers multiple leads of ECG on full-size reports and includes an alphanumeric keyboard for patient demographics and other data entry, an integrated 7' color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non real time reports.

The device has an optional feature of transmission and reception of ECG data, downloading of orders and patient demographics to and from a central ECG cardiovascular information system and supports exporting of ECG records in PDF. It also has an optional internal memory and removable storage to store resting ECG records.

The patient information can be entered with the help of optional bar code reader.

Clinical Trials Data Guard and audit trail options are also available to support electronic record requirements.

MAC™ 2000 ECG Analysis system can be used as a portable unit also.

Here's a breakdown of the acceptance criteria and study information for the MACTM 2000 ECG Analysis System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria for the MACTM 2000 ECG Analysis System. Instead, it emphasizes substantial equivalence to predicate devices and compliance with voluntary standards.

However, based on the statements, the implicit acceptance criteria are related to:

• Performance: Meeting all design requirements and performance claims.
• Functionality: Acquiring, analyzing, displaying, and recording ECG data in various modes (resting, arrhythmia, exercise, RR analysis).
• Usability: Providing features like alphanumeric keyboard, integrated display, thermal writer, hook-up advisor, and options for data transmission/reception.
• Safety: Compliance with relevant safety standards.
• Reliability: Demonstrating reliable operation.
• Substantial Equivalence: Being as safe and effective as the predicate devices.

Since no specific quantitative metrics are provided for the acceptance criteria, a table directly comparing them to reported device performance cannot be created with numerical values. The text only states that the device "meets all design requirements and performance claims."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a patient sample size for any clinical testing. It mentions "Testing on unit level, system level, as well as usability and safety parameters."
• Data Provenance: The document does not mention the country of origin of any data or whether it was retrospective or prospective. The study detailed appears to be a simulated use setting for verification testing rather than a clinical trial on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document does not mention the use of experts to establish ground truth for a test set related to interpretation or diagnosis. The testing described focuses on engineering verification, not clinical validation based on expert review.

4. Adjudication Method for the Test Set

• Since there's no mention of expert review or clinical ground truth establishment, no adjudication method (like 2+1 or 3+1) is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, MAC™ 2000 ECG analysis system, did not require clinical studies to support substantial equivalence." This means there was no study comparing human readers with and without AI assistance to measure an effect size.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The document refers to the "MACTM 2000 ECG Analysis System" as a device that "aquires, analyzes, displays, and records information." The analysis component is embedded in the device. The "Summary of Non-Clinical Tests" and "Summary of Simulated Use Setting" focus on "Design verification... several protocols that include electrical, mechanical, safety testing, reliability, and system design verification." This suggests testing of the integrated system and its analytical capabilities in a controlled engineering environment. However, it does not detail a standalone algorithm performance study in terms of diagnostic accuracy or specific metrics for its "interpretive analysis" option. The focus is on the device's overall functionality and safety, and its equivalence to predicate devices, rather than the isolated performance of its analytical algorithms against a clinical ground truth.

7. Type of Ground Truth Used

• For the described verification testing, the "ground truth" was effectively design requirements and established performance claims, as well as compliance with voluntary standards. There is no mention of clinical ground truth such as pathology, expert consensus, or outcomes data used for the "analysis system" part of the device. The verification focused on whether the device functions as designed and meets engineering specifications and regulatory standards.

8. Sample Size for the Training Set

• The document does not mention any training set size because it did not involve the development or validation of a new AI model with a training phase detailed in this submission. The device uses "the same fundamental technology as its predicate device MAC1600 ECG Analysis System" for acquiring, analyzing, recording, displaying, and printing ECG data. This suggests reliance on established algorithms, rather than newly trained ones requiring a dedicated training set as described in modern AI/ML submissions.

9. How the Ground Truth for the Training Set Was Established

• As no training set is mentioned in the context of this submission, the document does not provide information on how ground truth was established for a training set.

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