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Stimuplex® HNS 12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anaesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anaesthetics. This device can be used wherever peripheral anaesthesia is normally applied (i.e. physicians office or hospital).

The nerve stimulator Stimuplex® HNS 12 is a battery powered peripheral nerve stimulator for localization of nerve fibers in the tissue. During the operation the operating physician holds a stimulation cannula in his right hand. Simultaneous the operation of the device happens with his left hand. The physician can hold the device with the left hand and simultaneous alter the stimulation amplitude at the amplitude controller. The Stimuplex® HNS 12 generates negative, current-stabilized square pulses with selectable frequency, selectable pulse width and fine adjustable stimulation current. The pulse is shaped at both slopes by extremely fast active pulse drivers. An output amplifier specially designed for this application has an extraordinarily wide dynamic range and produces reproducible settings even below 0.1 mA. The stimulation frequency and the pulse width can be varied for different applications. The Stimuplex® HNS 12 nerve stimulator offers the facility for selecting a frequency of either 1 Hz or 2 Hz together with pulse widths of 0.1 ms, 0.3 ms or 1.0 ms. Two additional pulse widths: 0.05 ms and 0.50 ms can be enabled in options menu. Stimuplex® HNS 12 has a menu structure (in 26 languages) where the switch on parameters and options and setup parameters like tone volume, contrast, automatically switch off time, language can be configured. The battery voltage is in info menu in volt and percentage and during stimulation menu as symbol displayed.

The provided text is a 510(k) summary for the Stimuplex® HNS 12, a peripheral nerve stimulator. It focuses on demonstrating substantial equivalence to a predicate device and outlines the device's technical specifications and intended use. It does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of clinical performance or diagnostic accuracy.

The summary states: "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to: physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

This indicates that internal quality control procedures are in place, but it does not detail a study with the characteristics requested in your prompt (e.g., sample size, ground truth, expert adjudication, statistical performance metrics).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size, ground truth details, expert qualifications, adjudication methods, MRMC studies, or training set information based on the provided text.

The information given is primarily about regulatory clearance based on substantial equivalence, rather than a detailed performance study as you've outlined.

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