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Digital Electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.

It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.

The provided document is a 510(k) premarket notification for a Digital Electrocardiograph, Model: ECG-2000. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets acceptance criteria derived from a novel clinical trial.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in the context of a clinical performance study with specific metrics like sensitivity, specificity, accuracy, etc. Instead, it demonstrates compliance with technical specifications and safety standards to establish substantial equivalence. The "performance" reported is primarily in terms of meeting these engineering and safety benchmarks.

Note on "Intended Use": The proposed device extends its intended use to include pediatric patients, whereas Predicate Device 1 explicitly mentions "adult patients" in the comparison table. Predicate Device 2, however, is the exact same device, and its previous clearance (K133985) likely covered adult patients, and this submission seeks to add pediatric. The document explicitly states: "This submission is filed for extension of intended use...therefore, only the following standard was tested to verify that the device can meet its additional intended use: IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs."

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. The document states "No clinical study is included in this submission." The testing primarily involved product verification to standards (e.g., IEC 60601-2-25) rather than a clinical evaluation with a test set of patient data.
• Data Provenance: Not applicable, as no clinical data set was used for performance evaluation in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No clinical test set requiring ground truth established by experts was used.

4. Adjudication method for the test set

• Not applicable. No clinical test set requiring adjudication was used.

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. The device is a "Digital Electrocardiograph," which primarily acquires and displays ECG signals for analysis by healthcare professionals. It does not appear to incorporate AI for interpretation or act as an AI-assistive tool for human readers, nor was an MRMC study conducted.

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

• The document implies the device performs basic signal acquisition, filtering, and amplification, displaying these signals for human interpretation. There is no mention of an "algorithm" performing diagnostic interpretations in a standalone capacity that would require specific performance testing against a ground truth. The device "can help users to analyze and diagnose heart disease," which suggests it provides raw or processed signals for expert review, not an automated diagnosis.

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

• Not applicable. No clinical performance evaluation requiring a ground truth was conducted. The "ground truth" here is implied by the technical specifications and adherence to international standards for electrocardiographs.

8. The sample size for the training set

• Not applicable. This device is an acquisition and display system for ECG signals. There's no indication it employs machine learning or AI that would require a "training set."

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

• Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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