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The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.

The product is not a conventional diagnostic tool.

This product is single channel, standard 12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in family ,hospital consultation, doctor's diagnosis, physical check-up, social medical organizations etc. it can implement real time continuous records of clear and exact single-channel ECG waveform using thermo sensitive printer at the same time. waveforms also can be freezed at any time. it has manual and automatic modes to be chosen and Chinese/English operation interface, it is easy to be used.

The provided text is a 510(k) summary for the Contec Medical Systems Co., Ltd. ECG80A Single-Channel Handheld Electrocardiograph. This document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and technical specifications. Unfortunately, it does not contain the detailed information necessary to answer the questions about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert involvement as requested.

The document states: "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications." However, it does not provide the details of these design specifications as acceptance criteria or the performance results against them.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, expert involvement, and ground truth in detail based solely on the provided text.

The information that can be extracted and inferred is limited:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "met all design specifications, including electrical safety, EMC, specifications."
• Reported Device Performance: Not explicitly stated in terms of specific metrics against criteria. The conclusion is that the device "is substantially equivalent (SE) to the predicate device Cardiette microtel (K082124) and CARDIOLINE AR1200 (K051534)."

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: Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of experts: Not mentioned.
• Qualifications of experts: Not mentioned.
• Role of Experts: Not mentioned.

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

• Not mentioned.

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 study is mentioned. This device is an electrocardiograph, not an AI-assisted diagnostic tool as described. It "records and displays ECG waveform." It does not appear to involve AI assistance for interpretation.

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

• Not applicable as this is a device for recording and displaying ECG waveforms, not an algorithm for interpretation. The text states it "provides to the treating physician with relevant data on the cardiac rhythm" but does not indicate automated diagnostic interpretation. Furthermore, it explicitly states "The product is not a conventional diagnostic tool."

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

• Not mentioned.

8. The sample size for the training set

• Not applicable/mentioned, as no algorithm training is indicated for this device.

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

• Not applicable/mentioned, as no algorithm training is indicated for this device.

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