(53 days)
The intended use of SE-1201 12-channel electrocardiograph 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 offered to clinicians on an advisory basis only.
SE-1201 is 12-channel electrocardiograph, it's configured with a 7inch Multi-color screen with 800*480 dots resolution. SE-1201 is mainly composed of the ECG board, the power supply board, the Key board and the main board. SE-1201 can acquire 12 channel waveforms simultaneously, which can also print out 12 channel electrocardiograph wave simultaneously by a 216mm wide thermal printer, and the waveforms also can be displayed in LCD and stored in flash memory or send to PC by Ethernet. SE-1201 has the features as follows: Supporting barcode scanner Supporting multi-language ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves are displayed and recorded simultaneously Full alphanumeric keyboard (touch screen is optional) Real-time uploading to PC ECG Multiple file formats: DAT, PDF, SCP, FDA-XML High resolution thermal recorder, recording frequency response ≤150Hz Flexible printing formats The auto, manual, rhythm, R-R analysis and off modes can be chosen freely Automatic baseline adjustment for optimal printing Convenient operation of system setup and file management Measurement function and interpretation function Hint information of lead off, lack of paper, low battery capacity etc. Built-in rechargeable lithium battery with large capacity ECG data can be transmitted to the PC software through the net cable, or wireless AP (optional).
Here's an analysis of the provided text regarding the acceptance criteria and study for the SE-1201 device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly define acceptance criteria as quantitative metrics for specific performance parameters of an interpretive ECG algorithm (e.g., sensitivity, specificity for certain heart conditions). Instead, the "Test Summary" and "Conclusion" indicate a broader approach to demonstrating substantial equivalence for the entire device, which includes software functionality like "measurement function and interpretation function."
The acceptance criteria implied are that the device's overall performance and safety are comparable to the predicate device (MAC 5000 ECG Analysis System K014108). The study merely states that "Verification and validation testing was done on SE-1201" and concludes "This pre-market notification submission demonstrates that SE-1201 is substantially equivalent to the predicate device."
Therefore, a table of specific quantitative acceptance criteria and reported performance cannot be generated from the given text. The relevant parts are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Overall safety and effectiveness comparable to predicate device. | Substantially equivalent to the predicate device (MAC 5000 ECG Analysis System K014108). |
| Meets the requirements of applicable quality assurance measures. | Software testing, risk analysis, safety testing, and environment testing were applied. |
| Functionality (including measurement and interpretation function) as described. | Device has "Measurement function and interpretation function." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set, nor the data provenance (e.g., country of origin, retrospective/prospective nature). The "Test Summary" broadly states "Verification and validation testing was done," but no specifics about the dataset used for this testing are included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for any testing, particularly for the "interpretation function." Given that this is a 510(k) summary for an electrocardiograph, and not a detailed clinical study report for an AI diagnostic algorithm, such granular information is typically not included. The interpretation function is offered "on an advisory basis only," suggesting that human experts are ultimately responsible for diagnosis.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set. This level of detail is absent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not indicate that an MRMC comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, nor any effect size. This device is an electrocardiograph that includes an interpretation function, not explicitly an AI-assisted diagnostic platform in the contemporary sense that would warrant an MRMC study from this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not explicitly state that a standalone performance study was done for its interpretation algorithm. The "interpretation function" is listed as a feature, but its standalone diagnostic accuracy metrics are not presented. The overall "substantial equivalence" is for the entire device.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for evaluating the "interpretation function" (e.g., expert consensus, pathology, outcomes data). For an ECG interpretation algorithm of this era, ground truth would most commonly involve expert cardiologist interpretation or potentially correlation with patient outcomes or other diagnostic tests, but this information is not provided.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. The process described is for a predicate device comparison for an electrocardiograph, not an AI model requiring a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (see point 8), there is no information provided on how ground truth for a training set was established.
Summary of Missing Information:
This 510(k) summary is for a more traditional medical device (electrocardiograph) that includes an "interpretation function." It is not structured like a submission for a modern AI/ML diagnostic software, which would typically contain detailed performance metrics, ground truth establishment, sample sizes, and study designs for the algorithm itself. The focus of this document is on establishing substantial equivalence of the entire device, including its electrical, mechanical, and basic software functions, to a predicate device. Therefore, much of the specific information requested in the prompt regarding AI model evaluation is not present in this 2011 document.
§ 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).