(57 days)
HRV Tools is indicated when it is desired to analyze the basic rhythms of the R-R intervals in electrocardiograms. It only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses
HRV Tools is a software product (supplied on a CD) that analyzes the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis).
Here's an analysis of the provided text regarding the HRV Tools device, focusing on acceptance criteria and study data:
Unfortunately, the provided 510(k) summary for HRV Tools (K040313) is very brief and lacks detailed information regarding specific acceptance criteria, study sizes, expert qualifications, or detailed performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with explicit acceptance criteria.
Based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices in safety and efficacy for analyzing RR intervals in ECGs (time and frequency domains). | "HRV Tools is equivalent in safety and efficacy to the legally marketed predicate devices." (Conclusion on page 2) |
| Accurate operation of algorithms for RR interval analysis. | "Tests to check the operation of the algorithms 3. Accuracy tests" (Non-clinical tests on page 2) |
| Ability to analyze basic rhythms of RR intervals in electrocardiograms (time and frequency domains). | "HRV Tools is a software product ... that analyzes the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis)." (Description and Intended Use on page 2) |
| Does not make diagnoses. | "It only provides numerical analyses of the input electrocardiogram -- the program does not make diagnoses." (Intended Use on page 2 and Indications for Use Form on page 4) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "Tests with input data from the MIT database" as a non-clinical test. The MIT-BIH Arrhythmia Database is a public repository, but the specific number of records or patients used from it for testing is not stated.
- Data Provenance: The MIT-BIH Arrhythmia Database is likely the source for a portion of the test data. The country of origin for the database is primarily the US (collected at Boston's Beth Israel Hospital and Women's and Infants' Hospital). The study is retrospective in the sense that the database contains previously recorded data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For the MIT-BIH Arrhythmia Database, annotations (which serve as ground truth) are typically performed by cardiologists or trained technicians, but the document does not elaborate on this for the device's specific testing.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The device is a "Heart Rate Variability Analysis Program" and provides numerical analyses, not diagnostic interpretations for human readers to improve upon. The submission states, "It only provides numerical analyses of the input electrocardiogram -- the program does not make diagnoses."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the testing described appears to be standalone performance. The device analyzes RR intervals and provides numerical outputs. The non-clinical tests would evaluate the algorithm's performance in processing the input data and generating these numerical analyses. The statement "Clinical tests are not necessary since HRV Tools uses the same technology as the predicate devices" further supports that the focus was on the algorithm's standalone accuracy against known data/reference standards, rather than clinical utility in a human-in-the-loop scenario.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the "Tests with input data from the MIT database," the ground truth would likely be the expert-annotated RR intervals and arrhythmia information that are part of the MIT-BIH Arrhythmia Database. The submission does not specify ground truth for other "Validation tests" or "Accuracy tests."
8. The sample size for the training set
- Sample Size for Training Set: Not specified. The document only mentions testing with the MIT database, not explicit training data. It's possible the device uses well-established algorithms that don't require novel "training" in the machine learning sense, or that the training data details were not considered necessary for a 510(k) submission focused on substantial equivalence for this type of software.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not specified, as training set details are absent.
§ 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).