(252 days)
The CardioXP electrocardiograph is one of the tools that clinicians can use to evaluate and diagnose 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.
CardioXP is an EKG monitoring system that provides standard EKG diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG monitoring, data analysis and data management functions.
This document describes the Bionet CardioXP, an electrocardiograph. The acceptance criteria and supporting study information are derived directly from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "CardioXP complies with the EC11 standard". EC11 (now ANSI/AAMI EC11:2007/(R)2017) is a standard for diagnostic electrocardiographic devices, specifying general safety and performance requirements. The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular condition) for an interpretive algorithm, nor does it present explicit performance metrics against such criteria. Instead, compliance with the EC11 standard is presented as the primary "performance information."
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Compliance with EC11 standard | Complies with EC11 standard |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Because CardioXP complies with the EC11 standard, assessment of performance data is not necessary to determine of Substantial Equivalence for this type of device."
Therefore, there is no specific test set sample size reported for evaluating the interpretive algorithm's performance, as a comparative clinical effectiveness study was deemed unnecessary for substantial equivalence based on standard compliance. The data provenance (country of origin, retrospective/prospective) is not applicable/not reported for an absent test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific test set data was provided or analyzed for the interpretive algorithm's performance against ground truth, the number and qualifications of experts involved in establishing such ground truth are not applicable/not reported.
4. Adjudication Method for the Test Set
As there was no specific test set and no performance data presented for the interpretive algorithm, an adjudication method for the test set is not applicable/not reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this submission. The device's substantial equivalence was based on compliance with the EC11 standard rather than such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study of the algorithm's diagnostic accuracy was not presented in the provided document. The claim is based on compliance with a standard, not on a direct performance evaluation of the interpretive algorithm's diagnostic capabilities.
7. The Type of Ground Truth Used
Given that no performance data for the interpretive algorithm was presented beyond compliance with a technical standard, the type of ground truth (expert consensus, pathology, outcomes data, etc.) used for such an evaluation is not applicable/not reported. The submission indicates that the interpretive algorithm provides "computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information," implying that the algorithm's output is not the definitive ground truth.
8. The Sample Size for the Training Set
The document does not report any information regarding a training set sample size for the interpretive algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does not report how the ground truth for any training set, if one was used for the interpretive algorithm, was 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).