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The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both an automatic mode (tape analyzed without operator intervention) and in an interactive mode (operator can intervene and affect analysis).

The Pathfinder 700 Holter ECG analyzer is a high-speed Holter cassette analyzer capable of analyzing tapes recorded at 1.47 mm/second and 1.0 mm/second as well as solid-state recorders such as the Reynolds eRAM and the Braemar DL700. It is a successor to the Reynolds Pathfinder 3 analyzer, marketing of which has been approved by the FDA under 510 (k) number K871344. The unit features arrhythmia analysis, ST analysis, pacemaker beat deviation detection, and determination of beat types, in both an automatic and interactive mode. The system uses an icon-based, mousecontrolled, Graphical User Interface ("GUI"), visually similar to those found on the well-known Apple and Windows operating systems. Analysis is performed at 1000 times the recording speed, obtained by using parallel computations and a 188 megabyte random-access memory, in addition to a 1000 megabyte hard disk. Thus a 24 hours lible megabyte hard disk. Thus, a 24 hour Holter tape can be analyzed in approximately 1.5 minutes. A 486 motherboard is used to provide disk control and keyboard/mouse interfacing, while the analysis sections use parallel computing, based on the T400 and T425 transputers, a computer element which forms the basis of many parallel computing systems. Pathfinder system is mouse-controlled, and uses a cathoderay tube display and keyboard. The analysis is based on the Neilson principle or algorithm, which have been used on the previous Reynolds analyzers, and which have received in all approval. The backs and which have received 510(k) approval. The basic principles of the analysis are the same as those used previously by Reynolds; the new features of this system lie principally in its new electronic features, which have led to re-programming the equations and analysis principles.

The Reynolds Pathfinder 700 Holter Analyzer is a device designed to analyze ambulatory electrocardiograms (Holter tapes) for arrhythmias and ST segment deviations. The provided 510(k) summary focuses primarily on the device's technical specifications and comparison to predicate devices, rather than detailed performance metrics and a specific study design to prove acceptance criteria. Therefore, a comprehensive table of acceptance criteria and reported performance with exact numerical values is not explicitly available within this document.

However, based on the information provided, we can infer the general acceptance criteria and the type of evidence presented to support the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific numerical acceptance criteria and precise performance metrics are not explicitly stated in the 510(k) summary. The document describes the types of tests performed and the conclusion that the device meets safety and effectiveness standards comparable to predicate devices.

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

• Sample Size: The document mentions the use of "standard AHA test tapes" for clinical testing. It does not specify the number of AHA test tapes used.
• Data Provenance: The "standard AHA test tapes" are generally synthetic or well-characterized recordings used industry-wide for performance evaluation. Their specific country of origin or whether they represent retrospective or prospective patient data is not stated, but they are a standardized, known benchmark.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the "standard AHA test tapes." For standardized test tapes like AHA, the "ground truth" (i.e., known arrhythmias, ST changes) is inherent to the design and composition of the tape itself, often established through expert consensus at the time of their creation. It is unlikely that new experts were recruited specifically for this 510(k) submission to re-establish the ground truth of these pre-existing standard tapes.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned for the test set. Given that "standard AHA test tapes" were used, the ground truth is pre-defined within the tapes themselves, making re-adjudication by experts for each test typically unnecessary.

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

No MRMC comparative effectiveness study is mentioned. The study described compares the device's analysis (Pathfinder 700) to the analysis provided by predicate devices (Pathfinder 3, Marquette 8000) on standard test tapes. This is an algorithm-to-algorithm comparison, not a human reader comparison with or without AI assistance. Therefore, no effect size for human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "clinical tests" described explicitly compare the "analysis of the Pathfinder 700" to the "analysis provided by a predicate device" and another system (Marquette 8000) using "standard AHA test tapes." This is a direct evaluation of the algorithm's performance without human intervention, specifically in its "automatic mode." The summary states the system can operate in both automatic (no operator intervention) and interactive modes, and the comparison with predicate devices on test tapes would primarily evaluate its automatic, standalone capabilities.

7. Type of Ground Truth Used

The ground truth used for the clinical tests was standardized test data (AHA test tapes). For these tapes, the presence, type, and timing of arrhythmias and ST changes are pre-defined and known, serving as the benchmark against which the device's analysis is compared.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. It primarily discusses the device's hardware, software principles, and validation against predicate devices and standard tapes.

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

The document does not provide information on how the ground truth for any training set was established. Given the age of the device (1995 submission), detailed information on machine learning model training (including training data specifics and ground truth establishment) might not have been a standard requirement or reported in the same way as for modern AI/ML submissions. The analysis is based on the "Neilson principle or algorithm" which was utilized in previous Reynolds analyzers, suggesting an established, possibly rule-based or empirically developed, analytical methodology rather than a purely data-driven machine learning approach that would necessitate a large, explicitly defined training set with ground truth.

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