(90 days)
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The optional Spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.
The Welch Allyn CP 100™ electrocardiograph features a full alphanumeric key board, an LCD display, full-size user-programmable reports, and the ability to operate on either battery or AC power. ECG tests sent to a memory card are compatible with the Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The CP 100™ electrocardiograph is specifically intended for acquiring and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained healthcare providers. The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.
The Welch Allyn CP 200™ electrocardiograph can display, print, save, and send ECGs electronically. It features a full alphanumeric keyboard, a color display to preview ECGs and edit settings, storage for up to 50 ECG and 50 spirometry records, full-size user programmable reports, and the ability to operate on either battery or AC power. For centralized ECG data storage, the CP 200™ electrocardiograph can connect to a Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The CP 200 electrocardiograph is specifically intended for acquiring, viewing, storing, and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained health care providers. The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses. The electrocardiograph provides and optional interface to a pulmonary function device. Communication of ECG and spirometry data with a central data-management system is optional.
Here's an analysis of the acceptance criteria and the supporting study information for the Welch Allyn CP 100™ and CP 200™ Electrocardiographs, based on the provided text:
Acceptance Criteria and Device Performance for Welch Allyn CP 100™ and CP 200™ Electrocardiographs
The provided documentation details two main aspects of acceptance criteria and performance: the ECG interpretation algorithm and the spirometry functionality.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a specific table of acceptance criteria in the format of pass/fail thresholds for the device's diagnostic performance. Instead, it relies on demonstrating equivalence to predicate devices and adherence to established standards.
For the ECG Interpretation Algorithm (MEANS interpretive software):
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Equivalence to Predicate | The implementation of the MEANS interpretive software in the CP 100™ and CP 200™ electrocardiographs is equivalent in every respect to the implementation of this software in the CardioPerfect™ with MEANS device (cleared per K962854). |
| Algorithm Version | Both product families (Welch Allyn CP 100/200 and CardioPerfect™ with MEANS) implemented the 1996 version of the MEANS algorithms. |
| Standard Compliance | The MEANS algorithms were verified and found to be consistent with the requirements of IEC 60601-2-51:2003 (particular requirements for safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs). All requirements of recognized and applicable standards are in compliance (EC11 (AAMI/ANSI), UL 60601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25 and IEC 60601-2-51). |
| Specificity and Sensitivity | A copy of the specificity and sensitivity from the 1996 independent validation study of the MEANS algorithms (as presented for the Welch Allyn CardioPerfect™ with MEANS submission K962854) was provided. Specific numerical values are not given in this document. |
For the Spirometry Functionality (CP 200™ only):
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Component Equivalence | The CP 200™ uses the same flow transducer, signal-conditioning electronics, and tubing as the Medikro D9 Spirometer (K971336). |
| Standard Compliance (Accuracy & Precision) | The CP 200™ device meets all stated accuracy and precision requirements defined in the ATS standard, "Standardization of Spirometry: 1994 Update and 2005 version" published by the American Thoracic Society (ATS). |
2. Sample Size Used for the Test Set and Data Provenance
For the ECG Interpretation Algorithm:
The document refers to a 1996 independent validation study of the MEANS algorithms, stating that the specificity and sensitivity from that study were presented for a prior submission (K962854). However, the sample size for this test set is not specified in the provided text. The data provenance is implied to be from a validation study performed by the Department of Medical Informatics of Erasmus University Rotterdam in 1996. It's implicitly retrospective to the development of the 1996 MEANS algorithms.
For the Spirometry Functionality:
The spirometry functionality was validated by Robert O. Crapo, M.D. The test report, dated March 2, 2007, confirmed that the device meets ATS standard requirements. The specific sample size (number of patients or tests) used for this validation is not specified. The data provenance is from a study conducted at the Pulmonary Laboratory at LDS Hospital in Salt Lake City, Utah. It appears to be a prospective validation as part of the device's development/submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For the ECG Interpretation Algorithm:
The document mentions "The Department of Medical Informatics of Erasmus University Rotterdam independently validated the MEANS algorithms in 1996." It does not specify the number of experts involved or their specific qualifications (e.g., "cardiologist with X years of experience").
For the Spirometry Functionality:
The spirometry functionality was validated by one expert: Robert O. Crapo, M.D., Medical Director of the Pulmonary Laboratory at LDS Hospital in Salt Lake City, Utah. His qualifications as a Medical Director of a pulmonary laboratory indicate expertise in respiratory medicine.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1 or 3+1) for either the ECG interpretation algorithm validation or the spirometry functionality validation. For the ECG, it states "independently validated," but details of how ground truth was established by experts are not provided. For spirometry, Dr. Crapo's single validation implies a direct comparison against the ATS standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly mentioned or performed according to the provided text. The ECG algorithm's role is described as "guidance" for qualified physicians, but no study on its impact on human reader performance is detailed.
6. Standalone Performance Study
For the ECG Interpretation Algorithm:
Yes, a standalone performance study was done for the MEANS algorithm. The document states, "The Department of Medical Informatics of Erasmus University Rotterdam independently validated the MEANS algorithms in 1996." This validation assessed the algorithm's specificity and sensitivity directly, independent of a human-in-the-loop scenario.
For the Spirometry Functionality:
Yes, a standalone performance study was done for the spirometry functionality. "The spirometry functionality of the CP 200™, including the custom software, was validated by Robert O. Crapo, M.D." This validation confirmed the device's accuracy and precision against the ATS standard on its own.
7. Type of Ground Truth Used
For the ECG Interpretation Algorithm:
The type of ground truth used is implied to be expert consensus or expert interpretation from the validation study performed by the Department of Medical Informatics of Erasmus University Rotterdam. Specific details on how this consensus was achieved (e.g., against clinical diagnosis, pathology, or subsequent outcomes) are not provided.
For the Spirometry Functionality:
The ground truth for spirometry performance was established against the "Standardization of Spirometry: 1994 Update and 2005 version" published by the American Thoracic Society (ATS). This represents a recognized standard for accuracy and precision in spirometry measurements.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set of the MEANS interpretive algorithm or any other components of the devices. It only refers to the validation of existing algorithms.
9. How the Ground Truth for the Training Set Was Established
Since a training set nor its sample size is mentioned, the document does not provide information on how the ground truth for any training set was established. The focus is on the validation of pre-existing and adopted algorithms (MEANS, and the spirometry component based on Medikro D9 and ATS standards).
§ 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).