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The ECG Cables and Leadwires is intended to be used with ECG. The ECG Cables and Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The ECG Cables and Leadwire is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes, the other end is affixed/molded into one end of the trunk cable which are plug into an ECG monitor.

The provided text describes a 510(k) premarket notification for "ECG Cables and Leadwires" by Xinkang Medical Instrument Co., Ltd. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving novel effectiveness.

Therefore, the document does not contain the kind of information requested for many of your points, as it pertains to a device whose function is to transmit signals, not to generate diagnostic outputs that would require extensive clinical studies with ground truth, expert adjudication, or MRMC studies.

Here's a breakdown based on the provided text, addressing what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on adherence to recognized electrical and biocompatibility standards, and demonstrating substantial equivalence to a predicate device. Performance is framed in terms of meeting these standards.

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

• Not Applicable. The submission is for ECG cables and leadwires, which are accessories for ECG devices. The evaluation here is based on engineering and biocompatibility standards rather than a clinical "test set" of patient data for diagnostic accuracy. No human subject data (e.g., retrospective or prospective) is described for a "test set" of performance.

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

• Not Applicable. As per point 2, there is no "test set" in the context of diagnostic performance that would require ground truth established by experts.

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

• Not Applicable. There is no "test set" as defined in the context of diagnostic accuracy assessment.

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 device is ECG cables and leadwires, not an AI-powered diagnostic tool. MRMC studies for AI assistance are not relevant to this submission.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable. The "ground truth" for this device's acceptance is its adherence to established electrical, safety, and biocompatibility standards, and its functional equivalence to a legally marketed predicate device. This is determined through laboratory testing and engineering analysis, not medical ground truth from patient data.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. Not an AI/machine learning device.

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