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Digital Electrocardiographs are 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 diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs, E30, E65, E70 and E80, are 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 diagnose heart disease. There is no specific contraindication identified for the proposed devices.

The proposed devices acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.

The components of the proposed devices, Digital Electrocardiograph, include: (1) chest electrodes (2) limb electrodes, (3) cable and (4) Batteries;

The provided text is a 510(k) Summary for a Digital Electrocardiograph. It describes the device's intended use, comparison to a predicate device, and non-clinical tests conducted to establish substantial equivalence. However, it does not contain any information regarding specific acceptance criteria for device performance, a study proving the device meets these criteria, or details about sample sizes, ground truth establishment, or expert involvement as requested.

The summary primarily focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and compliance with general safety and performance standards (like IEC 60601-1 and AAMI EC11).

Therefore, based only on the provided text, I cannot fulfill most of your request.

Here's what can be extracted and what is missing:

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

• Information in text: The document states the device complies with certain standards (IEC 60601-1, IEC 60601-1-2, AAMI / ANSI EC11:1991/(R)2007, ISO 10993-5, ISO 10993-10). These standards define performance requirements, but the specific acceptance criteria and reported device performance against these criteria are not detailed in the summary. The text only mentions "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that it "complies with the following standards."

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

• Information in text: Not available.

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)

• Information in text: Not available. The device "can help users to analyze and diagnose heart disease," implying human interpretation, but no details of an expert-adjudicated test set are provided.

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

• Information in text: Not available.

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

• Information in text: Not available. This device is an electrocardiograph for acquiring ECG signals, not an AI-assisted diagnostic tool discussed in the context of MRMC studies.

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

• Information in text: Not available. The device is described as acquiring signals
  and assisting users in analysis and diagnosis, not a standalone automated diagnostic algorithm.

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

• Information in text: Not available.

8. The sample size for the training set

• Information in text: Not available. (No mention of a training set for an algorithm).

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

• Information in text: Not available. (No mention of a training set for an algorithm).

Summary of available information related to performance/acceptance criteria:

Further Details:

• Test Set Sample Size & Provenance: Not provided.
• Experts for Ground Truth & Qualifications: Not provided.
• Adjudication Method: Not provided.
• MRMC Comparative Effectiveness Study: Not conducted/reported.
• Standalone Performance Study: Not conducted/reported.
• Type of Ground Truth Used: Not provided.
• Training Set Sample Size: Not applicable/provided (device is for signal acquisition, not an AI diagnostic algorithm with a training set).
• Training Set Ground Truth Establishment: Not applicable/provided.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (predicate device) by showing similar intended use, technological characteristics, and compliance with recognized performance and safety standards for electrocardiographs. It does not provide the kind of detailed clinical study data often found for AI/CADe devices.

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