(277 days)
The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. Device features include as follows: Portable, lightweight design, Easy data input and operation, Alphanumeric keyboard and one-touch operation, Built-in rechargeable battery, AC/DC power supply, Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics, Two-step exercise test with periodic recording, Heart rate variability (HRV) analysis, Internal thermal printer and external printer, Support external archiving: USB flash disk, card reader, Data transmission to PC via Ethernet . WIFI or serial port.
The provided text is a 510(k) summary for the SE-601 Series Electrocardiograph, indicating that the submission is to modify the intended use to include pediatric patients. The document outlines general testing performed but does not provide specific acceptance criteria or a detailed study proving the device meets those criteria based on clinical performance metrics for the diagnostic software.
Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:
1. Table of acceptance criteria and reported device performance:
This information is not present in the provided document. The summary mentions "Software testing," "Performance testing," "Safety testing," and "Environmental testing" were applied, and that "Verification and validation testing was done," leading to the conclusion of substantial equivalence. However, no quantitative acceptance criteria or performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for ECG interpretation) are given.
2. Sample size used for the test set and data provenance:
This information is not present in the provided document. The text does not detail any clinical test set used for evaluating the device's diagnostic software for adults or the newly added pediatric population.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not present in the provided document.
4. Adjudication method for the test set:
This information is not present in the provided document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance:
This information is not present in the provided document. The device offers "Automatic analysis and diagnostic software (SEMIP)," but there's no mention of a comparative effectiveness study involving human readers. The interpretive ECG with measurements and statements is explicitly advisory only and not intended for pediatric patients, suggesting it's not designed to replace human interpretation, especially for diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
While the device has "Automatic analysis and diagnostic software (SEMIP)," the document does not provide details of any standalone performance study (e.g., sensitivity, specificity, accuracy) for this software, either for adults or for its (not yet approved for diagnosis) use in pediatrics. It only states that the interpreted ECG is advisory and only for adult patients.
7. The type of ground truth used:
This information is not present in the provided document. Given the lack of a detailed clinical study, the type of ground truth used to evaluate the diagnostic software's performance (e.g., expert consensus, pathology, outcomes data) is not specified.
8. The sample size for the training set:
This information is not present in the provided document. The document mentions the SEMIP software but does not detail how it was developed or trained.
9. How the ground truth for the training set was established:
This information is not present in the provided document.
In summary:
The provided 510(k) summary is primarily focused on demonstrating substantial equivalence to predicate devices for the device itself (acquiring ECG signals, physical characteristics, general software functionality like display and saving) and modifying its intended use to include pediatric signal acquisition. It does not present the detailed clinical performance data, acceptance criteria, or study methodologies that would be necessary to answer your specific questions regarding the diagnostic capabilities of the device's interpretive software. The interpretive software is explicitly noted as "advisory basis only" and "only intended to be used on adult patients." This strongly suggests that its diagnostic performance was not the primary focus of this specific 510(k) submission, or at least such detailed data is not included in this summary.
§ 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).