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The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.

Not Found

This is a 510(k) premarket notification for an ECG Electrode and not a clinical study report. Therefore, the detailed information requested regarding acceptance criteria, device performance, and study methodology is not available in the provided text. The document primarily concerns the FDA's determination of substantial equivalence for marketing the device.

However, based on the information provided, we can infer some general aspects:

• Device: ECG Electrode for Anaesthesia use
• Purpose: To transmit electrical signals from the body surface to a processor for producing an electrocardiogram or vectorcardiogram.

The FDA's review in a 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This often relies on performance data comparing the new device to the predicate, but specific acceptance criteria and detailed study designs are usually found in the sponsor's submission, not the FDA's decision letter itself.

No study is described in this document that proves the device meets specific acceptance criteria as if it were a novel, higher-risk device requiring extensive clinical trials. The FDA's letter indicates a finding of "substantial equivalence" to a predicate device.

Given the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document is an FDA clearance letter, not a study report. For an ECG electrode, general performance criteria would relate to signal quality, impedance, adhesion, biocompatibility, and electrical safety, usually benchmarked against a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): 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): Not applicable for an ECG electrode's 510(k) clearance, as "ground truth" in this context would likely refer to the accuracy of ECG signal transmission, not diagnostic interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is an electrode, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrode, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For an ECG electrode, "ground truth" would generally refer to the accurate and clear transmission of the heart's electrical activity, often verified against established physiological standards and predicate device performance. Specific methodologies are not detailed here.
8. The sample size for the training set: Not available (training sets are more relevant for AI/machine learning models).
9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The provided text is an FDA 510(k) clearance letter for an ECG electrode. It states that the device is "substantially equivalent" to legally marketed predicate devices. This means the manufacturer submitted information (likely including performance data) demonstrating that the ECG electrode for anesthesia use is as safe and effective as a previously cleared device. However, the specific details of that submitted data, including acceptance criteria, study design, sample sizes, and expert involvement, are not contained within this document.

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