(65 days)
SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
PC ECG is a kind of resting and exercising electrocardiograph based on PC. PC ECG including data sampling modules and software which can be installed on desktop or laptop PC. PC ECG can acquire 12 channel waveforms simultaneously, which can also print out 3/6/12 channel electrocardiograph wave simultaneously by a 210mm (A4) wide printer. Advanced digital filter technique has been used in PC ECG including baseline anti-drift filter AC noise (50/60Hz) filter EMG Filter and Low pass Filter, which can help the user to record the ECG more clearly. Measurement Moreover, the ECG and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease. PC ECG has the features as follows: 3/6/12-channel ECG wave display and printing simultaneously ECG wave frozen and review Measurement point adjustment and re-analyzing, manual measurement with high precision electronic ruler data management and processing function Report printing with PDF format, word format or JPG format Multi-language supporting Supporting auto measurement and diagnosing Automatic baseline adjustment for optimal printing
The provided text is a 510(k) summary for the Edan Instruments, Inc. PC ECG device. While it mentions “Software testing”, “Risk analysis”, “Safety testing”, and “Environment test” as quality assurance measures, it does not provide detailed acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy for disease detection).
The document is primarily a regulatory submission summarizing the device, its intended use, and its substantial equivalence to predicate devices (Cardiosoft/case cardiac testing system, K031561; and PC ECG, MODEL SE-1010, K092010).
Therefore, based only on the provided text, I cannot complete most of the requested information regarding acceptance criteria and performance studies.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Verification and validation testing was done on PC ECG" but does not define specific acceptance criteria (e.g., minimum sensitivity/specificity for particular conditions) or report detailed performance metrics against such criteria. The mention of "auto measurement and diagnosing" implies some diagnostic capability, but no performance figures are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set, its size, or provenance for evaluating diagnostic performance.
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)
- Cannot be provided. No information about a test set or ground truth establishment is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information about a test set or adjudication is present.
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
- Cannot be provided. The document does not describe any MRMC study or an "AI assistance" component in the context of improving human reader performance. The device includes an "interpretation program (SEMIP)" for diagnosis, but its impact on human readers is not studied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided definitively for diagnostic performance. The document states "Supporting auto measurement and diagnosing" and "can provide more detail information to diagnose heart disease" regarding the SEMIP. It also states "However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only." This suggests a standalone interpretive function, but no performance metrics (e.g., accuracy against a gold standard) for this standalone function are provided in the text.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No information about ground truth for performance evaluation is present.
8. The sample size for the training set
- Cannot be provided. There is no mention of a training set or its size.
9. How the ground truth for the training set was established
- Cannot be provided. There is no mention of a training set or its ground truth establishment.
Summary of Available Information from the Provided Text:
The document describes the PC ECG device as a PC-based electrocardiograph that acquires and processes 12-channel ECG waveforms. It includes an "ECG and interpretation program (SEMIP)" which can "provide more detail information to diagnose heart disease" and offers "auto measurement and diagnosing". However, the interpretive statements are "offered to clinician on an advisory basis only."
The regulatory submission focuses on demonstrating substantial equivalence to predicate devices (Cardiosoft/case cardiac testing system K031561 and PC ECG, MODEL SE-1010 K092010), rather than presenting a detailed clinical performance study for its interpretive function. The "Test Summary" only lists general quality assurance measures like "Software testing", "Risk analysis", "Safety testing", and "Environment test," without specifying performance-based acceptance criteria or results.
§ 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).