(101 days)
The ECG-9010K and ECG-9020K Cardiofax GEM electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart.
For non-interpretive applications, the ECG-9010K and ECG-9020K 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 age 3 years to adult.
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. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
The ECG-9010K and ECG-9020K have been classified as Class III by the Division of Cardiovascular. Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per 74 LOS.
Common names for the ECG-9010K and ECG-9020K include ECG and electrocardiograph.
Nihon Kohden's model ECG-9010K and ECG-9020K 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 ECG-9010K and ECG-9020K devices comply with the IEC 601-1 standard including subclause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for these devices. The devices are also in compliance with the following voluntary industrial standards: IEC 601-2-25 and CSA 601-1. Defibrillator Discharge Protection: Class I, Type CF.
The ECG-9010K and ECG-9020K are not intended to be sterile.
The devices were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58.
The ECG-9010K and ECG-9020K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation is performed to test the operation of the device software. The results confirm that the device performs within specifications.
The provided text describes the 510(k) notification for the Nihon Kohden ECG-9010K and ECG-9020K Cardiofax GEM electrocardiographs. However, this document does not contain the detailed information needed to completely fill out all sections of your request regarding acceptance criteria and the study proving device performance.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "The ECG-9010K and ECG-9020K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation is performed to test the operation of the device software. The results confirm that the device performs within specifications."
However, specific acceptance criteria values and the reported performance values are not provided in this document. It only confirms that tests were done and the device met its specifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document. The document mentions "performance testing procedures" but doesn't specify the details of the test set for these procedures, especially for the interpretive ECG program.
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)
This information is not provided. For the "interpretive ECG program," it states that "All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography," but it doesn't describe how ground truth was established for the device's validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The document describes a standalone device that provides an interpretive program but does not detail comparative studies with human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the document implies standalone performance testing for the device's "interpretive ECG program" as it is designed to provide an assessment. It states, "The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis." It also clarifies: "Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography." This suggests an algorithm-only assessment component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. While the device provides an interpretation, how the "ground truth" was established for validating this interpretation is not described.
8. The sample size for the training set
The document is a 510(k) summary for a medical device and does not delve into the specifics of the training data used for the interpretive algorithm. This information is not provided.
9. How the ground truth for the training set was established
Similar to point 8, this information is not provided in the 510(k) summary.
Summary of available information vs. missing information:
| Category | Information from Document | Missing Information |
|---|---|---|
| Acceptance Criteria & Performance | Device "performs within specifications." | Specific numerical acceptance criteria and reported performance values. |
| Test Set Sample Size & Provenance | Implied testing was done. | Specific sample size, country of origin, retrospective/prospective nature. |
| Ground Truth Experts (Test Set) | "Qualified physicians trained in electrocardiography" review output. | Number of experts, specific qualifications of experts establishing ground truth. |
| Adjudication Method (Test Set) | Not mentioned. | Adjudication method (e.g., 2+1, 3+1). |
| MRMC Comparative Study | Not mentioned. | Whether an MRMC study was done, effect size of human improvement with AI. |
| Standalone Performance | Yes, the interpretive program provides assessments. | Detailed standalone performance metrics (e.g., sensitivity, specificity, accuracy). |
| Type of Ground Truth | Not mentioned. | Whether it was expert consensus, pathology, outcomes, etc. |
| Training Set Sample Size | Not mentioned. | Specific sample size for training data. |
| Training Set Ground Truth Establishment | Not mentioned. | How ground truth was established for training data. |
In conclusion, this 510(k) document confirms that the device underwent various tests and met its specifications, and it has an interpretive ECG program. However, it lacks the detailed study methodology, sample sizes, and specific performance metrics that would typically be found in a detailed validation study report.
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