(84 days)
Stimuplex HNS-12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anesthetics. This device can be used wherever peripheral anesthesia 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 technical data of the device are: Battery: 9 Volt alkaline, Display: 1 graphic LCD Module, 1 tricolor (green, yellow, red) LED for status display, Operation: 1 control button to switch on/off the device, Adjustment knob to adjust the wanted stimulation current, 3 control buttons to switch the stimulation parameters, 4 control buttons for navigation and settings in the menus, Remote control (optional stimulation current adjustment), Power consumption: 6 mA (8 mA max in warning/alarm state), Stimulation current : max. 5mApp / 0Ω - 12 kΩ, Stimulation voltage : max. 95 Vpp, Stimulation frequency : 1 Hz / 2 Hz, Flowing current measuring tolerance: +/- 0.02 mA, Weight: 0.25 kg (with battery). The configuration of the electrode connection is realized with a 4 pin plug connection system, which ensures correct polarity of the electrode at all times. 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 battery-powered peripheral nerve stimulator. This document focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications and intended use. It does not contain information about studies proving the device meets specific acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity) of a diagnostic algorithm or a similar device that would typically involve a test set, ground truth, or expert review.
Therefore, I cannot populate the requested table or sections with information that is not present in the document.
Here's what can be extracted and a clear statement about what is missing:
1. Table of acceptance criteria and reported device performance:
The document describes the technical specifications of the Stimuplex® HNS 12. These could be considered "performance" in a functional sense, but they are not presented as acceptance criteria for a study demonstrating a specific clinical outcome or diagnostic accuracy.
| Feature | Reported Performance (Technical Data) |
|---|---|
| Battery | 9 Volt alkaline |
| Display | 1 graphic LCD Module, 1 tricolor (green, yellow, red) LED |
| Operation | 1 control button, Adjustment knob, 3 control buttons for parameters, 4 control buttons for navigation, Remote control (optional) |
| Power consumption | 6 mA (8 mA max in warning/alarm state) |
| Stimulation current | max. 5mApp / 0Ω - 12 kΩ |
| Stimulation voltage | max. 95 Vpp |
| Stimulation frequency | 1 Hz / 2 Hz |
| Flowing current measuring tolerance | +/- 0.02 mA |
| Weight | 0.25 kg (with battery) |
| Pulse widths | 0.1 ms, 0.3 ms, 1.0 ms (0.05 ms and 0.50 ms enableable) |
| Menu structure | 26 languages |
Acceptance criteria for a clinical study or performance study, specifying outcomes like success rates of nerve localization, are NOT provided in this document. The document primarily focuses on demonstrating that the new device's technical specifications and functionality are equivalent to the predicate device and that it meets manufacturing release specifications.
Information NOT present in the document:
- Sample size used for the test set and the data provenance: Not applicable as no specific performance study with a "test set" demonstrating clinical efficacy or diagnostic accuracy is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a stimulator, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Explanation of the Study and Device Justification:
The "study" or justification for the Stimuplex® HNS 12 meeting acceptance criteria is primarily based on demonstrating substantial equivalence to a legally marketed predicate device, the Stimuplex® HNS 11 (K003983), and adherence to manufacturing quality controls.
- Predicate Device Comparison: The document states, "The general technological characteristics of the Stimuplex® HNS 12 are similar in function, form and intended use to the Stimuplex® HNS 11 Peripheral Nerve Stimulator." The differences highlighted are additional functions (electro-charge display, menu structure in 26 languages), which are argued not to affect safety and effectiveness.
- Manufacturing Quality Control: The summary mentions, "All finished products are tested and must meet all required release specifications... 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." This indicates that the device's functional performance specifications are verified through in-house testing during manufacturing, conforming to product design specifications.
In essence, for this type of device and 510(k) submission, the "acceptance criteria" are implied to be conformity to the predicate device's safety and effectiveness profile, along with meeting internal design and manufacturing specifications. There is no detailed clinical study with performance metrics (like sensitivity/specificity) described because it's a substantially equivalent device submission, not a novel high-risk device requiring extensive new clinical efficacy data.
§ 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).