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K Number
K110118
Device Name
STIMTRODE SINGLE USE NERVE STIMULATOR
Manufacturer
XAVANT TECHNOLOGY (PTY), LTD.
Date Cleared
2011-02-17

(30 days)

Product Code
BXN,K11
Regulation Number
868.2775
Type
Special
Panel
AN
Reference & Predicate Devices
K072092
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stimtrode™ is intended to be used by an anesthetist during a peripheral nerve block procedure for nerve localization using invasive electrodes/needles (supplied separately).

Device Description

The Stimtrode device is a battery powered peripheral nerve stimulators that can be used for

  • · nerve locating using invasive electrodes/needs (not supplied)
    The stimulus is generated by a constant current source. The waveform is a square wave with 3 options for pulse width. These are: 0.1, 0.3 and 0.5 milliseconds.
    The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.
    The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises of a nerve locating needle that is attached at time of use.
AI/ML Overview

The provided text is a 510(k) summary for the Stimtrode Nerve Stimulator. It describes the device, its intended use, and its technological characteristics. However, it does not contain any information about acceptance criteria, a study proving device performance, sample sizes used, data provenance, ground truth establishment, or any comparative effectiveness studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Xavant Technology, XPOD/XMAP Nerve Stimulator K072092) and confirming its regulatory classification and intended use.

Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, study information, sample sizes, experts, adjudication, MRMC, standalone, ground truth type, training set size, training ground truth) as this information is not present in the provided text.

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).