(259 days)
Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers.
Easy ECG is consisting of intelligent tracing modules witch can be completed to a PC's serial port and software for completed to a PC's serial port and software for cing on any laser or inkjet printer.
The provided FDA letter (K972996) is a 510(k) clearance for the Easy ECG PC Based Electrocardiograph. This type of clearance indicates substantial equivalence to a legally marketed predicate device, rather than a de novo approval based on rigorous clinical trials demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, the document does not contain the detailed information required for a study proving device performance against acceptance criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance (country, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study details or effect size.
- Standalone algorithm performance (algorithm only without human-in-the-loop).
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The letter primarily focuses on the regulatory determination of substantial equivalence. The "Indications for Use" section (Page 3) briefly describes the device's function: "Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers. It is consisting of intelligent tracing modules which can be connected to a PC's serial port and software for processing and printing on any laser or inkjet printer." It also mentions "East ECG acquired simultaneously 12 leads for 4/8 seconds and then display the tracing on the monitor's screen." However, these are functional descriptions, not performance metrics or acceptance criteria for accuracy or diagnostic capability, which would be expected in a performance study report.
To answer your request, a different type of document, such as a clinical study report or a detailed premarket submission, would be necessary.
§ 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).