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SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

PC ECG including model SE-1010 has the similar functions of an ordinary electrocardiograph. ECG data can be sampled, displayed and stored in PC machine, and they can be printed with several kinds of printing types, including PDF format, word format and JPG format. ECG wave can be frozen and reviewed. Auto measurement and diagnosing is available, and Diagnose Template can be edited. PC ECG has the features as follows: - 3/6/12-channel ECG wave display and printing simultaneously - ECG wave frozen and review - Measurement point adjustment and re-analyzing, manual measurement with high precision electronic ruler - data management and processing function - Report printing with PDF format, word format or JPG format - -Multi-language supporting - Supporting auto measurement and diagnosing -- -Automatic baseline adjustment for optimal printing

The provided text is a 510(k) summary for the Edan Instruments PC ECG (model SE-1010). However, it does not contain a detailed study proving the device meets specific acceptance criteria for performance, especially regarding its "auto measurement and diagnosing" capabilities.

The document primarily focuses on:

• Substantial equivalence to a predicate device (Cardiosoft/case cardiac testing system, K031561).
• General device description and intended use.
• Mention of general quality assurance measures (software testing, risk analysis, safety testing, environment test, verification and validation testing) to demonstrate substantial equivalence.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the provided information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any specific performance study related to the "auto measurement and diagnosing" feature. The document only mentions "Verification and validation testing was done on PC ECG." without detailing the scope or data used.
• Data Provenance: Not specified.

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

• Not specified.

4. Adjudication method for the test set

• Not specified.

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 MRMC comparative effectiveness study is mentioned or detailed in the document. The device's diagnostic interpretation is stated to be "advisory basis only," which suggests a standalone or assistive role rather than a replacement for human interpretation based on a proven MRMC study.

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

• A standalone performance study for the interpretive algorithm is not detailed in the document. While "Auto measurement and diagnosing is available," no performance metrics (e.g., sensitivity, specificity, accuracy) are provided for this function.

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

• Not specified for any analytical or diagnostic performance studies.

8. The sample size for the training set

• Not applicable/Not specified. There is no mention of a machine learning or AI model being "trained" in this document. The "auto measurement and diagnosing" feature likely refers to rule-based algorithms or established clinical criteria, rather than a modern AI/ML model requiring a distinct "training set."

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

• Not applicable/Not specified, as no training set is mentioned.

Summary of what is present:
The 510(k) summary primarily asserts substantial equivalence to a predicate device based on similar functions and general quality assurance processes. It lists capabilities of the device but does not provide any specific quantitative performance data or details of studies validating the accuracy of its diagnostic or measurement features. The diagnostic statements are explicitly advisory.

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