(268 days)
ZBPro Diagnostic is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in Holter ECG data in the adult, non-paced population.
The product supports downloading and analyzing Lead II, CM5 (Ch 1), or Modified-MLII (Ch 2+) on retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings collected using standard Ag/AgCl wet electrodes in adult, non-paced patients. ZBPro is not intended for use with multi-lead analysis, wearable patches, or pediatric/paced recordings.
ZBPro Diagnostic can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.
ZBPro Diagnostic provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis.
ZBPro Diagnostic is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices.
The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
ZBPro Diagnostic interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
ZBPro is cloud-based Software as a Medical Device which aids healthcare professionals in interpreting ambulatory ECG recordings. The software comprises a secure web interface and a backend server hosted on Amazon Web Server (AWS). Authenticated users upload compatible 24-48 hour Holter ECG recordings via a web browser through an Application Programming Interface (API). ZBPro's proprietary ECG interpretation algorithm analyzes and annotates ECGs to provide supportive information for ECG and arrhythmia analysis.
ZBPro provides beat-by-beat ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate and Heart Rate Variability measurement, and rhythm analysis.
ZBPro consists of:
- A web interface which provides tools to upload data, measure, analyze and review numerous ECGs and patient diary logs, make manual annotation and generate ECG reports.
- An automated proprietary ECG interpretation algorithm which measures and analyzes ECGs to provide adjunct information for ECG diagnosis.
The backend application is established in Amazon Web Services (AWS) and accessed through an Internet connection and a web browser to perform ECG analysis and generate reports.
The provided FDA 510(k) clearance letter and summary for ZBPro Diagnostic contains information related to the device's acceptance criteria and the study conducted to prove it meets them. However, it does not provide explicit details for all the requested points, particularly numerical metrics for acceptance criteria and specific performance results. Instead, it refers to compliance with standards and successful completion of validation.
Here's an extraction of the available information, with notes on what is not explicitly stated:
Acceptance Criteria and Reported Device Performance
The document states that "All clinical input requirements were validated against a gold standard," and "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database in accordance with ANSI/AAMI EC57 and IEC 60601-2-47 reporting conventions." This implies the acceptance criteria were defined by these standards. However, the exact numerical thresholds for sensitivity, specificity, accuracy, etc., for each specific arrhythmia or beat type, are not explicitly stated in the provided text. Similarly, the reported numerical device performance (e.g., specific percentages for sensitivity or specificity) is also not given.
The table below reflects what can be inferred or is directly mentioned regarding the device's performance against its expected functions, without specific quantitative results.
| Acceptance Criteria (Implied from Standards & Functions) | Reported Device Performance (Inferred from "met requirements" and "successful") |
|---|---|
| Detection and analysis of common cardiac arrhythmias in Holter ECG data (adult, non-paced population, Lead II, CM5, Modified-MLII) | The software successfully provides "ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis." The validation testing was "successful and met all requirements." |
| Compliance with AAMI ANSI EC57:2012 (Testing and Reporting Performance Results of Cardiac Rhythm And ST-Segment Measurement Algorithms) | Performance validation testing was conducted "in accordance with ANSI/AAMI EC57... reporting conventions" and was "successful." This implies the device met the performance expectations outlined in this standard for relevant rhythm and beat detection. (Specific performance metrics are not provided in this document) |
| Compliance with AAMI ANSI IEC60601-2-47:2012 (Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems) | Performance validation testing was conducted "in accordance with... IEC 60601-2-47 reporting conventions" and was "successful." This implies the device met the basic safety and essential performance requirements for ambulatory ECG systems. (Specific performance metrics are not provided in this document) |
| ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate, and rhythm analysis. | ZBPro's proprietary ECG interpretation algorithm "analyzes and annotates ECGs to provide supportive information for ECG and arrhythmia analysis" and provides "beat-by-beat ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate and Heart Rate Variability measurement, and rhythm analysis." All software validation testing was "completed successfully and met all requirements." |
| Robustness under degraded signal conditions (noise stress testing) | "Additional noise stress testing using the ZBPro Noise Stress Testing (ZNST) database was conducted to evaluate algorithm robustness under degraded signal conditions." Implied successful completion, as overall conclusion is substantial equivalence. (Specific results are not provided) |
| Usability for healthcare professionals (Certified Cardiovascular Technicians) | "General usability tests... were performed by certified cardiovascular technicians and met all requirements." Usability tests were conducted to "validate the effectiveness of risk control measures associated with the user interface." |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "an adjudicated database" for performance validation testing but does not specify the sample size (number of patients or recordings) used for this test set.
- Data Provenance: The document does not specify the country of origin of the data. It states the testing was done on "retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings." This confirms the data was retrospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database." This implies that experts were involved in adjudication to establish ground truth. However, the number of experts used and their specific qualifications (e.g., radiologist with X years of experience) are not explicitly stated.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The term "adjudicated database" is used, indicating that a formal process was followed to establish ground truth. However, the specific adjudication method (e.g., 2+1, 3+1) is not explicitly described in the provided text.
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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 comparative effectiveness study involving human readers with and without AI assistance is mentioned. The study described focuses on the standalone performance of the algorithm against an adjudicated ground truth and user interface usability.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation of the algorithm was conducted. The document states: "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database." This refers to the algorithm's performance independent of a human-in-the-loop scenario.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established through expert consensus/adjudication, as indicated by the phrase "adjudicated database."
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The sample size for the training set:
- The document does not provide any information regarding the sample size of the training set used for the ZBPro Diagnostic algorithm.
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How the ground truth for the training set was established:
- The document does not provide any information on how the ground truth for the training set was established. It only refers to the "adjudicated database" for performance validation testing (typically the test set).
§ 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).