(386 days)
HERO is intended to acquire, store, analyze, and report on ECG data collected from infants. HERO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
HERO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HERO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The specialized HRV measurements produced by HERO have not been approved by the FDA for any specific clinical diagnosis.
HERO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
HERO is comprised of several off-the-shelf Personal Computers (PC's) capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring real-time network. Data is acquired, stored, analyzed, and displayed on a Bedside Monitoring Station (BMS) located near each patient. Demographic data is entered on a Central Monitoring Station (CMS). Results of the analyses are reported by both the CMS and the BMS. The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.
The provided text describes the "HERO HRV Analysis System" (K021230), but it does not contain acceptance criteria or a study proving that the device meets specific performance metrics.
The document is a 510(k) summary for a medical device cleared in 2003, which primarily focuses on establishing "substantial equivalence" to a predicate device rather than detailing performance acceptance criteria and a study to meet them.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not specify any quantitative acceptance criteria for the device's performance (e.g., accuracy, sensitivity, specificity for detecting HRV patterns). It describes the device's function (acquiring, storing, analyzing, and reporting ECG data for HRV patterns) but not how its performance against a ground truth was measured or what level of performance was deemed acceptable.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information on a test set sample size or its provenance is provided.
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)
- Missing. As there's no mention of a test set where ground truth was established, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No adjudication method is described.
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
- No. An MRMC comparative effectiveness study was not done. The device's intended use explicitly states: "HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis." This indicates it's a measurement tool, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied, but details missing. The device is described as an "HRV Analysis System" that identifies "HRV patterns that reflect transient decelerations and/or reduced baseline variability." This suggests a standalone algorithmic analysis. However, there are no performance metrics (e.g., how accurately it identifies these patterns) for a standalone performance provided in the document. The "Test Summary" only mentions software validation procedures and hardware certification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. No ground truth type is mentioned.
8. The sample size for the training set
- Missing. There is no information about a training set since the document describes a 510(k) for substantial equivalence to a predicate device, not the development and validation of a novel algorithm with training data.
9. How the ground truth for the training set was established
- Missing. Not applicable, as no training set is mentioned.
Summary of the study and its purpose:
The document describes the 510(k) premarket notification for the HERO HRV Analysis System (K021230).
- Purpose of the study (as presented in the 510(k) context): To demonstrate "substantial equivalence" of the HERO device to a legally marketed predicate device (K991786 GE Marquette MARS Unity Workstation with Heart Rate Variability (HRV) Option).
- Methodology (as described for this 510(k)): The summary states:
- "HERO software was tested under software validation procedures developed in accordance with the General Principles of Software Validation; Final Guidance for Industry and FDA Staff and the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices published by the FDA."
- "HERO hardware is UL 2601-1 (standard for Medical Electrical Equipment) tested and certified, and meets appropriate requirements for the intended environment."
- Conclusion: "HERO has a similar intended use as the predicate device. HERO raises no new questions of safety or efficacy when compared with the predicate device. Therefore, HERO is judged substantially equivalent to the MARS Unity Workstation with Heart Rate Variability (HRV) Option."
In essence, this document is a regulatory submission demonstrating equivalence, not a clinical performance study with defined acceptance criteria and performance data against a ground truth. The "testing" mentioned pertains to software validation and hardware safety/compliance, not a clinical trial to evaluate the accuracy or efficacy of the HRV analysis itself against a defined ground truth.
§ 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).