(58 days)
To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished 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 overread 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.
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 overread 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 PageWriter Trim Series Cardiograph is Philips Medical Systems' cardiograph offering a full complement of features, for both adult and pediatric patients. The Cardiograph offers increased speed and ease-of-use for patient data entry. The device also consists of a digital patient acquisition module, LCD display and rechargeable battery, thermal printer, optional barcode scanner or magnetic card strip reader. The Cardiograph provides crisp, easy-to-read ECGs on a standard page. Records are clearly labeled with ECG data and patient information.
This document primarily discusses the substantial equivalence of the Philips Medical Systems PageWriter Trim Series Cardiograph to a predicate device based on non-clinical testing. It does not provide detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria, particularly in the context of AI-driven performance metrics like sensitivity, specificity, or human-in-the-loop improvements.
Here's a breakdown of the information that can be extracted and where the document lacks detail regarding your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain a table of acceptance criteria or reported device performance in terms of specific diagnostic metrics (e.g., sensitivity, specificity, accuracy) for the analysis algorithms. It states that the device offers "measurements, data presentations, graphical presentations and interpretations."
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set related to the performance of the analysis algorithms. The testing mentioned is primarily for non-clinical aspects like electrical safety and software functionality.
- Data provenance is not mentioned as no clinical test set for algorithmic performance is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set for algorithmic performance is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set for algorithmic performance is described.
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:
- No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence through non-clinical testing and general device characteristics. It states the interpretations are "advisory" and "to be used in conjunction with the clinician's knowledge," implying a human-in-the-loop, but no comparative effectiveness study with AI assistance is described for the human reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the device includes "algorithms that provide measurements... and interpretations," the document does not describe a standalone performance study for these algorithms. The interpretation is always presented as advisory and requiring physician overread.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical test set for algorithmic performance requiring ground truth is described in this document.
8. The sample size for the training set:
- Not mentioned. The document describes the device, its intended use, and non-clinical testing for substantial equivalence, but it does not delve into the development or training of its algorithms.
9. How the ground truth for the training set was established:
- Not mentioned. Similar to point 8, the document does not provide details on algorithm development.
Summary of available information related to acceptance criteria and performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (PageWriter Touch Cardiograph, K020708) through non-clinical testing. The "acceptance criteria" are implied by compliance with various applicable standards and established test procedures for performance, functionality, and reliability, rather than specific clinical performance metrics for the interpretive algorithm.
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Acceptance Criteria (Implied from non-clinical testing):
- Compliance with AAMI EC11 (Performance Standard for Diagnostic Electrocardiographic Devices)
- Compliance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for safety)
- Compliance with UL 2601.1 (Safety Standard for Medical Electrical Equipment, Part 1: General Requirements)
- Compliance with IEC 60601-2-25 (Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs)
- Compliance with IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests)
- Performance, functionality, and reliability characteristics of the device and algorithm software testing follow established test procedures and quality system.
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Reported Device Performance (from "Device Description" and "Comparison of Technological Characteristics"):
- Acquires multi-channel ECG signals from adult and pediatric patients.
- Records, displays, analyzes, and stores ECG signals.
- Provides measurements, data presentations, graphical presentations, and interpretations.
- Offers "increased speed and ease-of-use for patient data entry."
- Provides "crisp, easy-to-read ECGs."
- Has the "same ECG measurements, adult and pediatric analysis programs, software filtering algorithm, ECG basic controls" as the predicate device.
- Has similar standardization, DC offset sensitivity, time base and accuracy stability, bandwidth, input dynamic range as the predicate device.
The main takeaway is that this 510(k) submission confirms the device's substantial equivalence based on safety and non-clinical performance characteristics, not on a detailed clinical study demonstrating the diagnostic performance of its interpretive algorithms against a defined ground truth or improvement in human reader performance. The interpretive algorithm is explicitly stated to be "advisory" and requires a qualified physician to "overread and validate (or change)" the computer-generated interpretation.
§ 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).