(58 days)
The intended use of the ECG Series Electrocardiograph is to acquire ECG signals from adult and pediatric patients through the 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 ECG with measurements and interpretative statements is offered to the clinician on an advisory basis only.
The ECG Series Electrocardiograph is designed to acquire, analyze, display and record ECG signals from the patient body surface by ECG electrodes. After being amplified, filtered and analyzed, the ECG signal waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer or USB printer. ECG data, result and information of patient may be stored in the memory file. The file can be transmitted to a PC through UART or Ethernet interface. Also the device can be configured with the auto analysis software as optional which helps to carry out auto measurement and auto interpretation.
The ECG Series Electrocardiograph device consists of two basic components: the signal acquisition module and central processing unit. Models provide rechargeable battery.
The ECG series electrocardiograph can be divided into two types of devices: the ECG -12, ECG -12 Plus, and the ECG-3F Plus, ECG-3F, ECG-3 Plus and ECG-3 series.
The ECG-3F Plus, ECG-3F, ECG-3 Plus and ECG-3 series are three channel Electrocardiographs, which can print out three channel electrocardiograph waves simultaneously by an 80 mm wide thermal line printer. The different between and ECG-3F and ECG -3 is the shell.
ECG-12 and ECG-12 Plus series are twelve channel Electrocardiographs, and they can print out twelve channel electrocardiograph waves simultaneously by a 216mm wide thermal line printer. The difference between the ECG-12 and ECG-12 Plus is the shell.
The provided 510(k) summary for the ECG Series Electrocardiograph does not contain information about specific acceptance criteria, a study proving device performance against such criteria, or details regarding ground truth, expert involvement, or sample sizes related to clinical validation.
Instead, the summary focuses on technological characteristics, safety, and substantial equivalence to predicate devices. It states that:
- "Testing was conducted to validate and verify that the ECG Series Electrocardiograph met all design specifications and was substantially equivalent to the predicate devices."
- The quality assurance measures applied were Software Testing, Hardware Testing, Safety Testing, and Electromagnetic Compatibility Testing.
- It refers to a "declaration of conformity to harmonized standards (Exhibit 13)" (not provided in the input).
- The conclusion reiterates that "this premarket notification submission demonstrates that the ECG Series Electrocardiograph is substantially equivalent to the cleared K091513 SE Series Electrocardiograph and K014108 MAC 5000 ECG Analysis System."
Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions as the required information is not present. The submission appears to rely on demonstrating equivalence to predicate devices through technical and engineering testing rather than a clinical performance study with specific metrics and ground truth.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met all design specifications and was substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. This submission focuses on engineering testing and substantial equivalence, not a clinical study on patient 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 applicable, as there's no mention of a clinical study requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as there's no mention of a clinical study.
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, there is no mention of a multi-reader multi-case comparative effectiveness study. The device includes optional "auto analysis software" but no study comparing human readers with and without this assistance is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No, a standalone performance study of the "auto analysis software" is not detailed. The submission focuses on the overall device's safety and equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable, as no clinical study requiring a ground truth is described. The device's performance is validated against "design specifications" and compliance with standards.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. There is no mention of a machine learning component for which a training set would be required, or if the "auto analysis software" uses pre-trained models, their training data is not discussed.
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable.
§ 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).