(118 days)
The ECG-9110K and ECG-9130K Cardiofax Q 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-9110K and ECG-9130K 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 solo basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
The ECG-9110K and ECG-9130K 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-9110K and ECG-9130K include ECG and electrocardiograph.
Nihon Kohden's model ECG-9130K are intended for medical purposes to process the electrical signals transmitted through two or more electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart.
The ECG-9110K and ECG-9130K 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-9110K and ECG-9130K 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-9110K and ECG-9130K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications.
The provided document describes the Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q electrocardiographs and their submission for 510(k) clearance. However, the document does not contain the detailed acceptance criteria or a study proving the device meets specific performance metrics in the way modern AI/ML device submissions do.
This submission is from 1998/1999, which predates the widespread use of sophisticated AI/ML algorithms in medical devices and the associated rigorous performance study requirements now common. The information provided heavily focuses on regulatory compliance, safety standards, and substantial equivalence to a predicate device, rather than detailed performance metrics.
Therefore, I will extract what is available and note the gaps according to your requested format.
Acceptance Criteria and Device Performance Study for Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 601-1 standard (including subclause 56.3(c)) | "The ECG-9110K and ECG-9130K devices comply with the IEC 601-1 standard..." |
| Compliance with 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables | "...including subclause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables." |
| Compliance with voluntary industrial standards: IEC 601-2-25 and CSA 601-1 | "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 | Stated as Class I, Type CF. (Implies compliance with this classification) |
| Electromagnetic compatibility | "The ECG-9110K and ECG-9130K were subjected to electromagnetic... testing procedures." Results: "These tests verified the operation of the device." |
| Environmental compatibility | "The ECG-9110K and ECG-9130K were subjected to... environmental... testing procedures." Results: "These tests verified the operation of the device." |
| Safety performance | "The ECG-9110K and ECG-9130K were subjected to... safety... testing procedures." Results: "These tests verified the operation of the device." |
| General performance (within specifications) | "The ECG-9110K and ECG-9130K were subjected to... performance testing procedures." Results: "These tests verified the operation of the device." "The results confirmed that the device performed within specifications." |
| Software validation | "Software validation tested the operation of the software of the device." Results: "The results confirmed that the device performed within specifications." |
| Substantial Equivalence to ECG-9320A | "Therefore based on the above, Nihon Kohden believes that the ECG-9110K and ECG-9130K are substantially equivalent to the ECG-9320A." (FDA concurred with this finding) |
Regarding the interpretive ECG program:
The document explicitly states: "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 solo basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography."
This framing suggests that the "interpretation program" is an assistive tool, and the focus of the submission is on the electrical and functional performance of the electrocardiograph hardware and basic software, rather than a standalone diagnostic performance of the interpretive algorithm against specific clinical endpoints. Therefore, a detailed study proving performance of the interpretive algorithm in a clinical context, beyond verifying it "performed within specifications," is not described in this document.
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. The testing described (electromagnetic, environmental, safety, performance, software validation) would typically use hardware units or simulated conditions, not a dataset of patient ECGs in the way an AI/ML algorithm is evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This information is not provided as there is no described test set of clinical data for an algorithm.
4. Adjudication method for the test set
N/A - Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided document. The focus is on the device's adherence to technical standards and functional specifications, and its substantial equivalence to a predicate device. The interpretive program is explicitly stated as an "assistive" tool requiring physician review.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone performance study of the interpretive algorithm. The "software validation" mentioned would likely pertain to its functional accuracy against internal specifications rather than clinical diagnostic performance. The indications for use emphasize the assistive nature of the interpretive program, requiring review by qualified physicians.
7. The type of ground truth used
For the general device performance and software validation, the "ground truth" would be the engineering specifications and expected behavior of the device as designed. For the interpretive program, the document does not specify how its "assessments" were validated or against what type of ground truth (e.g., expert consensus, pathology, outcomes data). Given the era and nature of the submission, it's likely it was validated against internal logic and a reference ECG database typical for interpretive algorithms of that time, but this is not detailed.
8. The sample size for the training set
N/A - The document does not describe the development or training of a specific clinical algorithm, nor does it refer to a "training set."
9. How the ground truth for the training set was established
N/A - Not applicable, as no training set is described.
N/A