(31 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 name of this device is the Philips PageWriter Cardiograph. The modification provides the following additional capabilities: improved ease of use ( 3 step ECG), improved human factors engineering with patient interface module, 802.11 g wireless capability, compatibility with extended lead ECG interpretive algorithm.
The provided 510(k) summary for the Philips PageWriter Cardiograph (K080999) does not contain detailed information regarding specific acceptance criteria, study methodologies, or the performance results of the device's interpretive algorithm.
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
This information is not provided in the given text. The summary states that "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 detail what specific acceptance criteria were used or what the measured performance metrics were.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
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)
This information is not provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) 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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The submission highlights that the interpretive ECG is "offered to the clinician on an advisory basis only" and "A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation," implying human-in-the-loop operation, but no study comparing human performance with and without AI assistance is described. The focus appears to be on the standalone performance of the algorithm and its equivalence to a predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone evaluation of the algorithm's performance can be inferred. The text states:
- "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate."
- "The modification provides the following additional capabilities: compatibility with extended lead ECG interpretive algorithm."
While specific results are not presented, the testing of the "new algorithm" and its "interpretive algorithm" suggests a standalone evaluation to confirm its functionality and characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the given text.
8. The sample size for the training set
This information is not provided in the given text. The document refers to "testing involved use of applicable consensus standards, system level tests, integration tests, and verification of risk mitigation identified in the hazard analysis," but it does not specify details about a training set.
9. How the ground truth for the training set was established
This information is not provided in the given text.
Summary of what is known:
- Device: Philips PageWriter Cardiograph (Model 860315)
- Purpose: 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.
- Intended Use: Advisory only; interpretations are to be used in conjunction with a clinician's knowledge, physical examination, ECG tracings, and other clinical findings. A qualified physician must over-read and validate or change the computer-generated interpretation.
- Predicate Device: Philips cardiograph cleared under K020708.
- Claim of Equivalence: The new device is substantially equivalent to the predicate.
- Testing: Involved "applicable consensus standards, system level tests, integration tests, and verification of risk mitigation identified in the hazard analysis." The testing aimed to establish "performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate."
§ 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).