(173 days)
Pajunks's MultiStim SENSOR is intended for nerve stimulation during anaesthesia delivery; first for percutaneous identification of peripheral nerves and second for percutaneous localizations. This device is indicated for adults only.
The MultiStim SENSOR devices are hand-held, battery-driven peripheral nerve stimulators for this purpose. The devices can be used for:
- . Nerve finding with peripheral nerve stimulation needles
- Percutaneous localization .
In relaxation monitoring for general anesthesia, the peripheral nerve stimulation technique is used to interpret the muscular feedback to stimulation pulses applied through adhesive skin electrodes in regards to the level of muscle relaxing drugs in the patient. Special functions do support this. Due to the fact, that the stimulation is done through the skin, much more electrical power is needed. That's why a stimulation current range of 0-60mA is needed.
In both applications, negative, monophasic pulses are to be generated by the devices and applied to humans either through peripheral nerve stimulation needles or through selfadhesive stimulation electrodes on the skin. Since the human body acts as a variable resistor and the anesthesiologist sets the device to a certain stimulation current, the nerve stimulator has to act as a constant-current-source. A built in microprocessor constantly adapts the voltage applied to the patient in order to compensate the varying patient's resistance and to provide a constant current through the patient.
I am sorry, but the provided text from the 510(k) summary (K061172) does not contain the detailed acceptance criteria and study information typically found in a clinical study report for device performance.
The document is a 510(k) Summary of Safety and Effectiveness, which primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly describes the device, its intended use, and indicates that it is substantially equivalent to another Pajunk device (K011308).
Therefore, I cannot extract the specific information you requested, such as:
- A table of acceptance criteria and reported device performance: This detail is absent. The document focuses on equivalence, not setting and reporting performance against specific acceptance metrics.
- Sample size used for the test set and data provenance: No information about a specific test set or clinical study for performance evaluation is provided.
- Number of experts used to establish ground truth and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone algorithm performance: Not mentioned, as this is a physical medical device (nerve stimulator), not an AI algorithm.
- Type of ground truth used: Not applicable in the context of this 510(k) submission approach.
- Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How ground truth for the training set was established: Not applicable.
The 510(k) process for a device like a nerve stimulator often relies on engineering testing, compliance with standards (e.g., electrical safety, EMC), and comparative testing to show that the new device performs "as well as" or "similarly to" the predicate device for its intended use, rather than a clinical study with detailed performance metrics against a defined ground truth as would be seen for a diagnostic or AI-enabled device.
§ 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).