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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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Stimuplex® Pen is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, lor looding openhold peripieral hervey. Ban invesive device non invasive device.

The Stimuplex® Pen is an electrode for cutaneous stimulation which, when connected to the Stimuplex® HNS 11 or HNS 12 nerve stimulator and placed on the skin, it conducts electrical impulses which initiates muscular contractions and/or synchronous electrical paresthesia whitin the distribution area of a nerve. The nerve passes perpendicularly to the place where a response is observed at the lowest level of current. This designated point of needle entry is situated directly perpendicular with the nerve.

The provided text is a 510(k) summary for the Stimuplex® Pen, a device for cutaneous electrical nerve stimulation. It does not include detailed studies with specific acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness.

The document primarily focuses on establishing substantial equivalence to a predicate device (Nerve Mapping Probe for NeuroTrace III Nerve Stimulator K023342) based on general technological characteristics, intended use, and safety. There is no mention of a clinical study designed to quantitatively assess the device's performance against predefined acceptance criteria.

Therefore, I cannot fulfill all parts of your request based on the provided text. However, I can extract what is available regarding the device's "performance" and the general approach to demonstrating its "safety and effectiveness."

Here's a breakdown of what can be inferred or directly stated from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document mentions "required release specifications" and "product design specifications" for manufacturing and quality control. However, it does not provide quantitative acceptance criteria (e.g., a specific accuracy or sensitivity threshold for nerve localization). The general acceptance criterion implied is that the device functions as intended to conduct electrical impulses for cutaneous nerve stimulation.
• Reported Device Performance:
  • Functionality: "It conducts electrical impulses which initiates muscular contractions and/or synchronous electrical paresthesia within the distribution area of a nerve."
  • Mechanism: "The nerve passes perpendicularly to the place where a response is observed at the lowest level of current. This designated point of needle entry is situated directly perpendicular with the nerve."
  • Safety & Effectiveness (in comparison to predicate): "The small power density difference doesn't affect safety and effectiveness for the intended use."

2. Sample size used for the test set and the data provenance:

• The document does not report on a specific test set or clinical study with a defined sample size for evaluating the device's ability to locate nerves. Instead, it refers to manufacturing and quality control testing.
• Data Provenance: Not applicable, as no clinical performance data is presented. The device manufacturer is Stockert GmbH, based in Freiburg, Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical study involving expert ground truth establishment for a test set is described.

4. Adjudication method for the test set:

• Not applicable. No clinical study involving a test set or adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document does not describe a multi-reader multi-case comparative effectiveness study. Its equivalence claim is based on technological characteristics and intended use compared to a predicate device, not on a human-in-the-loop performance study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, to an extent, but not in the context of an "algorithm." The Stimuplex® Pen is a physical electrode device, not an AI algorithm. The closest equivalent to "standalone" performance testing mentioned is the "physical testing" and "visual examination" conducted as part of the manufacturing process to ensure the device meets "product design specifications" and "required release specifications." These tests are performed on the device itself.

7. The type of ground truth used:

• Manufacturing Specifications / Functional Output: For the manufacturing and quality control tests mentioned, the "ground truth" would be whether the device physically conforms to its design specifications (e.g., dimensions, material properties) and functionally produces the expected electrical output as defined by the associated nerve stimulators (Stimuplex® HNS 11/12).
• Not applicable for clinical performance evaluation as described in the request (e.g., expert consensus, pathology, outcomes data).

8. The sample size for the training set:

• Not applicable. The Stimuplex® Pen is a hardware device, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI model is involved.

Summary of Device Acceptance and Study (based on provided text):

The Stimuplex® Pen's acceptance for marketing is based on demonstrating substantial equivalence to a previously legally marketed predicate device (Nerve Mapping Probe for NeuroTrace III Nerve Stimulator K023342) under the 510(k) pathway.

The "study" or evidence to prove the device meets acceptance criteria primarily involved:

• Comparison of Indicational Use: Showing that the Stimuplex® Pen has the same intended use as the predicate device (location of superficial peripheral nerves).
• Comparison of Technological Characteristics: Demonstrating that the fundamental technology (cutaneous electrical stimulation) and materials are equivalent. The differences (nerve stimulation parameters of the associated stimulators and tip diameter) were deemed not to affect safety and effectiveness.
• Manufacturing and Quality Control Testing: The document states, "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release includes, but is 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 individual units are tested against engineering and quality standards, but it's not a clinical performance study.

In essence, the "acceptance criteria" presented in this document are those for establishing substantial equivalence to a predicate device, supported by internal manufacturing quality controls, rather than a clinical performance study against specific objective performance metrics.

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