(298 days)
The BSP HyperO™ Rest System is intended to be used during rest ECG tests, using the analysis of high frequency components present within the central portion of the QRS complex (HF-QRS). The device outputs a reduced amplitude zone (RAZ) value for the physician to interpret (based on reported clinical study results). The device is indicated for use in the ECG interpretation of patients with acute chest pain presenting to the Emergency Department, aged 18 years and above, as an additional adjunctive aid during initial patient presentation. The significance of the HF-QRS changes and interpretation of the HyperQTM Rest analysis must be determined by a physician, based on the reported clinical study results presented in the device labeling.
The HyperQTM Rest System measures, processes, stores, and displays information derived from an electrocardiogram (ECG) with a high sampling rate (1000Hz). The device analyzes and records the High Frequency components of the QRS complex of standard ECG (HFQRS). The device displays the HFQRS to the user and also summarizes the analysis to generate an indication whether observed changes are within normal HyperO range, or constitute significant HyperO changes (Reduced Amplitude Zones, a.k.a RAZ); or represent a non-diagnostic test (unreadable). These findings are used as an aid in the clinical evaluation of acute chest pain on initial presentation to the Emergency Department.
Here's a summary of the acceptance criteria and the study details for the HyperQ Rest System, based on the provided FDA submission document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA document focuses on demonstrating substantial equivalence to predicate devices rather than specific quantitative performance metrics as "acceptance criteria" in the way one might see for a diagnostic AI. The primary acceptance criterion appears to be the ability to identify Reduced Amplitude Zones (RAZ) in HF-QRS signals as an aid in diagnosing acute chest pain, with performance comparable to its predicate (HyperQ™ AD-100) and suitable for rest ECG analysis.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Primary Indication: Identify Reduced Amplitude Zones (RAZ) in HF-QRS signals for patients with acute chest pain (as an adjunctive aid for physician interpretation). | Effectiveness demonstrated in a clinical study: "Results demonstrated that the device can be used as an aid in the identification of Reduced Amplitude Zones (RAZ) values in patients presenting with acute chest pain to an Emergency Department, aged 18 years and above." The device delivers an "automatic interpretation indicating significant HyperQ changes or changes within normal range for all tests that were readable." This implies the device successfully outputs RAZ values that align with a gold standard, though specific metrics (e.g., sensitivity, specificity, AUC) are not provided in this summary. |
| Safety and Efficacy Equivalence to Predicate Device: HyperQ™ AD-100 system (K102579) and GE MAC 800 Resting ECG Analysis System (K090212). | Substantially Equivalent: "The indications for use and technological characteristics of the BSP HyperQ™ Rest device are substantially equivalent to the indications for use and technological characteristics of the Predicate GE MAC 800 Resting ECG Analysis System and the HyperQ AD-100 System." |
| "The new BSP HyperQTM Rest System is identical in its hardware to the HyperQ™ AD-100 System." | |
| "Software algorithm was modified, software validation testing was performed. The results... demonstrated that the device meets its specifications, which are similar to those of the predicate device. These performance tests demonstrated that the minor differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size for the test set used in the clinical study. It only mentions that "Demographic data, ECG recordings and gold-standard diagnostics were used as a source for validating the diagnostic accuracy of the system."
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of Experts and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only mentions that the "gold standard diagnosis" was obtained from a "database."
4. Adjudication Method
- Adjudication Method: Not specified. The document states the device's analysis was "compared to a gold standard diagnosis from the database," but it does not detail how that gold standard was established in terms of expert review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not explicitly described or noted in the provided documents. The study described focuses on the device's standalone performance compared to a "gold standard diagnosis."
- Effect size of human readers with AI vs. without AI assistance: Not applicable, as an MRMC study was not conducted or reported.
6. Standalone Performance
- Was standalone (algorithm-only) performance done? Yes, the described clinical study assessed the device's standalone performance. "High frequency ECG signals were analyzed to obtain an automatic interpretation... The analysis was based solely on the digital data from the ECG device and was compared to a gold standard diagnosis from the database." The device "outputs a reduced amplitude zone (RAZ) value for the physician to interpret."
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was referred to as "gold standard diagnosis from the database." The specific nature of this gold standard (e.g., expert consensus of ECGs, confirmed pathology, clinical outcomes, or a combination) is not explicitly detailed. Given the indication (acute chest pain), the gold standard likely reflects a clinical diagnosis, potentially supported by further diagnostics or outcomes, but this is an inference.
8. Sample Size for the Training Set
- Sample Size: This information is not provided. The document describes a clinical study to demonstrate effectiveness but does not delve into the development or training of the algorithm itself, nor the data used for it.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: This information is not provided. The document focuses on the validation study and its ground truth, not the ground truth used during the algorithm's development or training phase.
§ 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).