(130 days)
To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation.
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.
The Philips ECG algorithm Software Release PH100B is a modification to a previously cleared device. The modification is a change that provides interpretive analysis capability for additional posterior and right sided heart lead placement locations beyond the standard lead placements used with a 12 lead ECG. The modification also incorporates a subset of the diagnostic statement changes recommended in the Journal of the American College of Cardiology Volume 49, No.10, 2007, pages 1128-1135. "Recommendations for the Standardization and Interpretation of the Electrocardiogram".
The provided text does not contain detailed information about specific acceptance criteria or the study used to prove the device meets these criteria. It focuses on regulatory aspects, substantial equivalence to predicate devices, and general statements about verification and validation.
However, based on the input provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. The document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate," but it does not specify what those performance characteristics are (e.g., sensitivity, specificity for certain conditions) or what the acceptance criteria for those characteristics were.
2. Sample size used for the test set and the data provenance
The text mentions "Testing involved use of standard ECG databases," but it does not specify the sample size of the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given text.
4. Adjudication method for the test set
This information is not provided in the given text.
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
The text mentions that "Results from interpretive ECG analysis programs are used as in an advisory nature. Physicians are required to over read each ECG report and also consider the ECG waveforms, the patient's clinical history before agreeing with the ECG analysis program statement." This implies that the device is intended to be used with human-in-the-loop. However, a formal MRMC comparative effectiveness study to quantify human reader improvement with versus without AI assistance and its effect size is not explicitly described in the provided text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The text strongly emphasizes the advisory nature of the algorithm and the requirement for physician over-read. It states, "Results from interpretive ECG analysis programs are used as in an advisory nature. Physicians are required to over read each ECG report and also consider the ECG waveforms, the patient's clinical history before agreeing with the ECG analysis program statement." This suggests that the device is not intended for standalone use, and thus, a standalone performance study in the context of clinical decision-making is unlikely to have been performed or prioritized for this regulatory submission. However, the "verification, validation, and testing activities" would have evaluated the algorithm's performance on its own before integrating it into the system.
7. The type of ground truth used
The text mentions "standard ECG databases." For ECG interpretation algorithms, the ground truth for such databases is typically established by expert consensus of cardiologists or other qualified physicians, often based on a combination of ECG findings and clinical context. However, the specific method of ground truth establishment is not detailed in the provided text.
8. The sample size for the training set
The text mentions "standard ECG databases" for testing but does not specify the sample size for the training set of the algorithm.
9. How the ground truth for the training set was established
The text mentions using "standard ECG databases" for testing, but it does not describe how the ground truth for the training set was established. It's generally assumed that algorithms trained on such databases would have their ground truth established by expert consensus or a similar rigorous annotation process, but this is not explicitly stated for this device's training data.
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