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The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The carded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

The ME6 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 Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs ME12P 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 diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiograph ME15P 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 diagnose heart disease. Digital Electrocardiographs shall he used in healtheare facilities by doctors and/or trained healthcare professionals.

The Mediblu ME3 Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.

The Mediblu ME6P Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.

The Mediblu ME12P Digital Electrocardiograph is designed to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

The Mediblu ME15P Digital Electrocardiograph is designed to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

The provided document is a 510(k) Premarket Notification for the Mediblu ECG System Models ME3, ME6P, ME12P, ME15P. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a device from scratch through clinical studies with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Instead, the submission focuses on comparing the subject devices to existing predicate devices to demonstrate that their indications for use, technological characteristics, and performance are substantially equivalent, implying that they are as safe and effective as the legally marketed predicate devices.

The document states:

• "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (Page 0)
• "The non-clinical test data demonstrates that the Mediblu ECG system models are substantially equivalent to digital electrocardiograph systems cleared for marketing in the US." (Page 15)
• "There are no differences between the subject devices and the predicate devices." (Page 15)

The acceptance criteria here is "substantial equivalence" to a predicate device, which is demonstrated by presenting a side-by-side comparison of technical specifications and intended use. The "study" proving this largely involves non-clinical testing to ensure the device meets specified technical performance (e.g., input impedance, frequency response, noise level) and safety standards (e.g., IEC60601-1), and then detailing how these align with the predicate device.

Here's a summary of what is provided, framed in relation to your request, and why it doesn't fit the typical "acceptance criteria and study" for a de novo or PMA submission:

Mediblu ECG System Models (ME3, ME6P, ME12P, ME15P) 510(k) Premarket Notification

This submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices, not to prove de novo safety and effectiveness through clinical trials against specific performance acceptance criteria. The "acceptance criteria" for a 510(k) is that the device is as safe and effective as a predicate device.

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

• Acceptance Criteria (for 510(k)): Substantial equivalence to predicate devices, meaning the intended use and technological characteristics are the same, or if different, the differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: Instead of a single "performance" score against an acceptance criterion, the document provides detailed technical specifications for each Mediblu model (ME3, ME6P, ME12P, ME15P) and directly compares them to their respective predicate devices. The "performance" is implicitly demonstrated by showing that all key technical specifications and features are "Same" as the predicate.

Example Table (Extracted from document for ME3 comparison):

Similar tables showing "Same" for all key characteristics are provided for ME6P (vs. iE6), ME12P (vs. iE12), and ME15P (vs. iE15).

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

• Not Applicable in this context. This 510(k) relies on non-clinical test data to demonstrate that the device meets safety and performance standards equivalent to the predicate, and that there are "no significant differences." It doesn't involve a separate "test set" of patient data for algorithm performance as would be required for an AI/ML device with a specific diagnostic claim. The comparison is based on the device's inherent physical and electrical properties, and its functional specifications.

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

• Not Applicable. As there is no "test set" of patient data requiring expert ground truth, experts for this purpose are not mentioned.

4. Adjudication method for the test set

• Not Applicable.

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

• Not Applicable. This is not an AI/ML-driven diagnostic device being evaluated for its interpretive or assistive capabilities. It's a standard electrocardiograph device.

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

• Not Applicable. The device does have an "analysis feature" and "interpretive statements," but these are explicitly stated to be "offered to clinician on an advisory basis only" (Page 2). The 510(k) substantiation focuses on the device's functional equivalence for acquiring ECG signals, not on the performance of its interpretive algorithms. The substantial equivalence relies on comparison of physical and electrical characteristics, and the fact that its advisory features are similar to the predicate.

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

• Not Applicable. The "ground truth" for this submission are the established technical specifications and safety standards (e.g., AAMI EC11, IEC 60601-1) and the documented specifications of the predicate devices.

8. The sample size for the training set

• Not Applicable. No training set for an AI/ML algorithm is discussed.

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

• Not Applicable.

In conclusion, the document serves as a 510(k) Preamarket Notification, which fulfills regulatory requirements by establishing substantial equivalence to previously cleared devices. It does not contain the detailed study information typically associated with proving the performance of a novel diagnostic algorithm or AI-driven device against specific quantitative acceptance criteria on a patient dataset.

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