(21 days)
The ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart. The product is a portable ECG acquisition terminal, which measures up to 12 lead ECG waveforms. You can record the resting ECG waveforms automatically or manually. In the automatic recording mode, ECG analysis is automatically performed and after ECG waveforms are recorded, the ECG analysis result is automatically printed.
The ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are intended to monitor the patient's heart rate electrically, the devices have been developed as the devices to select the operators, amplify, record or measure the electric potential captured by the electrodes attached to the patient's thoracic and extremities parts. Based on the information output by the devices, the devices will help the doctors for their cardiovascular diagnostication.
For non-interpretive applications, the ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are intended for use with a full range of patient populations as determined by a clinician.
The devices also provide an interpretive ECG program intended for use with patients are 3 years and older. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. Qualified physicians trained in electrocardiography recommend all assessments provided by the interpretation programs for review.
The Nihon Kohden ECG-1250A and ECG-1350A devices are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart. The product is a portable ECG acquisition terminal, which measures up to 12 lead ECG waveforms. You can record the resting ECG waveforms automatically or manually. In the automatic recording mode, ECG analysis is automatically performed and after ECG waveforms are recorded, the ECG analysis result is automatically printed.
The ECG-1250A and ECG-1350A have a color LCD screen, which allows you to preview 2.8 seconds of 12 lead ECG waveforms. The devices also include data transmission through wired LAN or wireless LAN to personal computers or another electrocardiographs, prepares a full-page file up to 12 channels on 210 mm recording paper for the ECG-1350A and up to 6 channels on 110mm recording paper on the ECG-1250A, the device is compact, lightweight and easy to carry. The ECG-1350A's A4 notebook weighs 3.9kg without battery or recording paper. The ECG-1250A's A4 notebook weighs 2.0 kg without battery or recording paper.
The provided text describes a 510(k) summary for the Nihon Kohden ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs. It focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards, rather than detailing specific performance criteria or a study design for a new device performance claim.
Therefore, many of the requested details about acceptance criteria, study design, expert qualifications, and ground truth establishment are not present in the provided text, as this document focuses on regulatory compliance and substantial equivalence through existing standards and testing, not novel performance claims.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Sterility | Not sterile (stated) |
| Regulatory Standards Compliance | Complies with IEC-60601-1 standard and sub-clause 56.3 (c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. |
| Environmental robustness | Subjected to tests including environment, vibration, impact, and drop. (Reported in post qualification test report for ECG-1250A Series (Report No. 1667) and ECG-1350A series (report no.1785)). |
| Electromagnetic Compatibility (EMC) | EMC test including EMI, flicker, static, emission immunity, burst, surge, conductive immunity, voltage dip, and operator's manual check. (Reported in post qualification test report for ECG-1350A series test report 1667 and ECG-1250A Series test report 1785). |
| Safety (Display) | Safety test conducted for display using prototypes (ECG-1250P and ECG-1350P). |
| Overall Performance | Test results confirmed that the device performed within specifications. |
2. Sample size used for the test set and the data provenance:
- Not specified in the provided text. The document mentions "tests" and "test reports" but does not detail the sample sizes for these tests or the origin of any data used (e.g., number of ECG recordings, patient demographics, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. The document alludes to the "interpretive ECG program" providing an assessment to "assist the physician in diagnosis" and states "Qualified physicians trained in electrocardiography recommend all assessments provided by the interpretation programs for review." However, it does not detail how ground truth was established for testing the interpretive program, nor the specific number or qualifications of experts involved in such a process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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:
- No MRMC study is mentioned or implied. The document describes an "interpretive ECG program" intended to "assist the physician in diagnosis," but it does not present a study comparing human readers with and without this assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document mentions an "interpretive ECG program" that "provides an assessment of ECG waveform rhythm and morphology." This program operates independently to generate its assessment before a physician reviews it. However, the document does not provide performance metrics for this standalone algorithm, nor does it detail a study conducted purely on its standalone performance. The focus is on its assistive role.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the provided text for the interpretive component's evaluation. The interpretive program provides assessments, which are then subject to review by "qualified physicians." This implies expert review is the ultimate ground truth or adjudication, but the method for establishing this ground truth for the purpose of evaluating the algorithm's performance is not described. For the fundamental device performance (e.g., electrical safety, physical robustness), the "ground truth" is adherence to established engineering and regulatory standards.
8. The sample size for the training set:
- Not specified in the provided text. The document briefly mentions an "interpretive ECG program," implying an underlying algorithm, but it does not discuss its development, training data, or training set size.
9. How the ground truth for the training set was established:
- Not specified in the provided text. As with the training set size, the method for establishing ground truth for any training data for the interpretive program is not mentioned.
§ 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).