(104 days)
The intended use of the QED 1000 is to record 12-lead ECG signals from adult patients from body surface ECG electrodes. This device can acquire, display, record, and store these ECG signals for review by the user.
The QED 1000 is intended to be used in healthcare facilities by trained healthcare professionals. A qualified physician must over-read all computer-generated tracings.
The QED 1000 is designed for use by a qualified physician to evaluate the electrocardiogram of adult patients as part of clinical diagnosis.
The Quantitative Electocardiographic Detector (QED) is a 12-lead resting electrocardiograph. It is a reusable device for acquiring, displaying, and storing the 12-lead electrocardiogram.
This document does not contain the detailed information necessary to complete all sections of your request, particularly regarding specific acceptance criteria, detailed study design, and statistical outcomes. The provided text primarily consists of a 510(k) summary and an FDA clearance letter for the Quantitative Electrocardiographic Detector (QED 1000).
However, I can extract information related to the device's functional and safety testing as an indicator of how it meets requirements.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
| Performance Metric/Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional & Performance Requirements | Device underwent electromagnetic compliance and electrocardiograph standard testing in accordance with EN 60601-1-2: 2007 and ANSI/AAMI EC 11: 1999/(R) 2001. No specific quantitative performance values (e.g., sensitivity, specificity for detecting specific ECG phenomena) are provided. |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2: 2007 |
| Electrocardiograph Standards | Compliance with ANSI/AAMI EC 11: 1999/(R) 2001 |
Missing Information: The document states that the device "met its functional and performance requirements" through testing against specified standards. However, it does not provide specific quantitative acceptance criteria for clinical performance metrics (e.g., accuracy in waveform measurement, arrhythmia detection, etc.) nor does it report specific numerical performance results from these tests beyond stating compliance.
2. Sample size used for the test set and the data provenance
Missing Information: The provided text does not specify a sample size for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective) for performance evaluation. The type of testing mentioned (EMC, DVM standards) typically does not involve patient data in the same way clinical performance studies do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: The document does not mention any experts used to establish ground truth for a test set. The testing described focuses on engineering standards compliance rather than clinical interpretation.
4. Adjudication method for the test set
Missing Information: No information is provided regarding an adjudication method, as no specific test set requiring expert adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
Missing Information: The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. The QED 1000 is described as a device to "acquire, display, record, and store" ECG signals for review by a user, with a qualified physician over-reading all computer-generated tracings. This implies a human-in-the-loop scenario, but no study comparing human readers with and without AI assistance is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: The document does not describe a standalone algorithm performance study. The device is an electrocardiograph that acquires, displays, records, and stores ECG signals, implying its primary function is data capture and presentation for human review, not automated diagnostic interpretation without human oversight. The statement "A qualified physician must over-read all computer-generated tracings" reinforces that it's not a standalone diagnostic device.
7. The type of ground truth used
Missing Information: No specific ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned, as the described testing relates to technical and safety standards rather than clinical diagnostic accuracy against a reference standard.
8. The sample size for the training set
Missing Information: The document does not mention a training set sample size. This device is an electrocardiograph, and the summary focuses on its functionality and compliance with technical standards, not on internal AI/algorithm training which would typically involve a training set.
9. How the ground truth for the training set was established
Missing Information: As no training set is mentioned, there is no information on how its ground truth would have been established.
§ 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).