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The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors: Neurovision Medical Products Nerveana Axon Eclipse Medtronic - NIM XLTEK EP Works Nicolet Viking Cadwell Cascade Neurosign Avalanche

Spes Medica Dragonfly Laryngeal Surface Electrode are single used electrodes for evoked EMG monitoring of the larynx and it to be inserted and retained in position against the larvngeal muscle by use of an endotracheal tube. The Electrodes are intended to be used as disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. Spes Medica produces two different families of electrodes: Family A and Family B. The family A and B mentioned above are the same product because, have been developed with same intended use, design, materials, packaging and other technological characteristics. The manufacturing processes are the same for both configurations (Family A and Family B) but the substrates and the shape of the electrodes are different. Indeed, for the family A the substrate for the Silver ink is a polyester film and for the family B the substrate for the Silver ink is carbon loaded vinyl. Furthermore, both families use the same connection to the EMG unit.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for the "Dragonfly Laryngeal Surface Electrodes," focusing on demonstrating substantial equivalence to previously marketed devices. It describes the device, its intended use, and compares it to predicate devices but does not include details on specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How training set ground truth was established.

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