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The disposable probe is used:

• to locate and identify cranial motor nerves during ENT and intra-cranial procedures
• to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots
• to locate, identify and monitor cranial motor nerves during surgery
  The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

There are three types of disposable probes: Concentric, Bipolar and Monopolar
Disposable Concentric probe The Concentric probe is very precise and has a diameter of only 1 mm. They are especially useful when working with the microscope, and allow the surgeon to differentiate between cranial nerves, to stimulate within the Internal Auditory Canal, or to stimulate fine fibers of the extra-cranial nerve without stimulating surrounding tissue.
Disposable Bipolar probe The Bipolar probe has both the active and return electrode builds in to the probe. Both tips of the Bipolar probe must come into contact with tissue in order for the stimulation current to flow. The Bipolar probe will stimulate through a small amount of tissue. The Bipolar probe may be used in skull-base surgery and those involving peripheral motor nerves.
Disposable Monopolar probe The Monopolar probe has a single active electrode, but must have a remote return electrode connected to the patient. The Monopolar probe is insulated to a tip free coating length of 2 mm, so it is capable of very precise stimulation. The probe should be touched onto the tissue until the nerve is located. The Monopolar probe is designed to be used to stimulate the tumor mass or when a large spread is required.

The provided document describes a 510(k) premarket notification for "Needle electrodes" (Proprietary Name) or "Disposable probe" (Common/usual Name) by Technomed Europe. This document focuses on establishing substantial equivalence to previously marketed devices and does not contain information about studies proving the device meets acceptance criteria. The information provided is primarily for regulatory clearance and outlines the device's description, intended use, and technological characteristics.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or details about test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Details of standalone algorithm performance studies.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document's structure is typical for a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the medical device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It generally does not include detailed clinical study results or performance metrics in the way that would typically be found in a clinical trial report or a performance validation study.

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