(149 days)
EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device-CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.
The EKG-PLUS II Software is a program which receives, displays, stores and prints out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device.
The provided text describes a 510(k) submission for the EKG-PLUS II Software. However, it does not include detailed information regarding discrete acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or ground truth methodologies that would typically be found in a performance study section.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "The performance of the EKG-PLUS If Software was comprehensively tested with the CardioCare-2000 and CardioTouch-3000. All functions as defined in the specifications were completely verified and validated."
This indicates that internal specifications for the software's functions served as the acceptance criteria. However, the document does not provide specific quantitative acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) or the reported performance metrics against those criteria. It only states that the functions were "completely verified and validated."
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. The device is an ECG analysis system, implying it processes data from ECG devices. While it might perform some interpretive functions (like its predicate), the text does not detail a study where human experts independently establish a ground truth to evaluate the device's diagnostic accuracy.
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
There is no mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as "EKG-PLUS II Software ECG Analysis System," an "algorithm only" product for displaying, storing, and printing ECG data, and performing analysis. It's not presented as an AI-powered assistive tool for human interpretation in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the described "EKG-PLUS II Software" is a standalone algorithm as it is an "ECG Analysis System" intended to "receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device." The "Non-clinical tests" section focuses on the performance of the software itself in conjunction with the specified ECG devices. The conclusion states it is "as effective, and performs as well as the CARDIOVIEW ECG Interpretive Software" (predicate device), implying a standalone, algorithmic comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states "All functions as defined in the specifications were completely verified and validated." This implies an engineering-centric verification and validation against internal functional and technical specifications, rather than a clinical ground truth like expert consensus on diagnostic interpretations, pathology, or outcomes data. If there were interpretive capabilities, the ground truth methodology for those specific functions is not detailed.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text. As a pre-2009 submission, it's less likely to extensively detail machine learning training sets in the way more recent AI/ML device submissions would. The "analysis" capabilities are likely based on established ECG interpretation algorithms rather than a trained machine learning model in the contemporary sense.
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