(85 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 DXL 12/16-lead ECG Algorithm provides an analysis of the amplitudes, durations, electrical axis, and morphologies of the ECG waveforms and associated rhvthms.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or corresponding reported device performance values. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All defined reliability requirements and performance claims | "The Philips ECG Algorithm software meets all defined reliability requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "standard ECG databases" but does not specify the sample size for the test set or the country of origin of the data. It's also not stated whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It mentions that "physicians are required to over read each ECG report."
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions that "A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation," suggesting a single physician review rather than a multi-reader consensus process for adjudication within the context of the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The device is referred to as an "advisory" tool that clinicians review and validate (or change), implying human-in-the-loop, but no comparative study to quantify improvement is described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was implied as the device "provides an analysis of the amplitudes, durations, electrical axis, and morphologies of the ECG waveforms and associated rhvthms" and "interpretive ECG analysis programs are used as in an advisory nature." However, specific metrics of standalone performance are not provided. The study's focus, as described, seems to be on the overall validation of the algorithm's output which is then reviewed by a physician.
7. Type of Ground Truth Used
The document implies that the ground truth for the "standard ECG databases" was established by physician interpretation, as it states that "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." Thus, it can be inferred that expert consensus (physician interpretation) was the basis for ground truth, or at least the standard against which the device's output was compared.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. Given the context of ECG analysis, it would likely also involve expert physician interpretation of ECGs, possibly with consideration of patient outcomes or other clinical findings, but this is not detailed.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).