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The Cardiofax CE electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or wireless transmission of data to a remote printer and/or computer.

For non-interpretive applications, the device is 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.

Cardiofax CE, PEA-1110K series, is a portable ECG acquisition terminal, which measures 12 lead ECG waveforms. The measured ECG waveforms are analyzed and transferred to an ECG data filing system thru a wireless LAN. The device features a built-in battery.

The provided 510(k) submission for the NIHON KOHDEN AMERICA PEA-1110K Series (Cardiofax CE) is a summary document for a substantial equivalence determination, not a detailed study report. Therefore, it does not contain the specific information requested in many of the categories, such as detailed acceptance criteria with performance metrics, sample sizes for test sets (beyond general statements about compliance), specifics on expert involvement, or details on ground truth establishment for a diagnostic algorithm.

The submission focuses on establishing substantial equivalence to a predicate device (ECG-9130K) by demonstrating that the new device has similar indications for use, fundamental technology, and meets relevant safety and performance standards. The "study" referenced is primarily a battery of engineering and software validation tests to confirm the device operates within specifications and meets regulatory standards, rather than a clinical performance study with specific diagnostic accuracy endpoints.

Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "testing procedures" and "software validation" but does not give a number of cases, patients, or data points used for these tests.
• Data Provenance: Not specified. It's likely these were internal engineering validation tests, potentially using synthetic data or a limited set of internal human data, but no details are provided.

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)

• Not Applicable / Not Specified. The document describes a Class II device (Electrocardiograph) that has an "interpretive ECG program" (an algorithm). However, the primary focus of this submission is on the device's technical specifications and substantial equivalence, not on the clinical performance validation of the interpretive algorithm itself. There is no mention of experts establishing a ground truth for a diagnostic test set in this summary. The ECG interpretation is stated to be "on an advisory basis" and requires review by "qualified physicians trained in electrocardiography."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Specified. As no diagnostic performance study of the interpretive algorithm (with a test set and ground truth determination by experts) is described, there's no mention of an adjudication method.

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. This type of study was not conducted or reported in this 510(k) summary. The submission focuses on the standalone device's compliance and equivalence, not on its assistive capabilities for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, implicitly, for the interpretive program's internal validation. The text states, "Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications." This suggests the algorithm within the device was tested to ensure it generated interpretations as designed. However, the clinical diagnostic accuracy of this standalone algorithm (e.g., sensitivity, specificity for specific conditions) is not reported or mentioned as part of the "acceptance criteria" presented in this document for the 510(k) submission. The interpretation is explicitly "advisory" and requires physician review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not specified for the interpretive algorithm's diagnostic performance. For the non-diagnostic aspects (safety, electrical performance, software function), the ground truth was presumably defined by engineering specifications, regulatory standards (like IEC 60601-1), and internal performance benchmarks.

8. The sample size for the training set

• Not specified. The document does not describe the development or training of the interpretive ECG algorithm.

9. How the ground truth for the training set was established

• Not specified. The document does not describe the development or training of the interpretive ECG algorithm.

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