Search Results

Stockert NEURO N50 is a RF generator for general high frequency applications:

1. Lesioning nerve tissue for functional neurosurgical procedures; or
2. Radiofrequency heat lesion procedures for the relief of pain; or
3. Stimulation procedures like provoking stimulation, localized stimulation, blocking stimulation or intraoperative test stimulation

The system consists of a radio frequency generator and accessories intended for neurological applications. Its purpose is to generate RF energy for delivery to a site in neurological tissue via a neurological instrument for a specified time period. The thermal energy emitted at the site of application produces a lesio that interrupts an electrical active area of neurological tissues. The STOCKERT NEURO N50 can be used either in bipolar or unipolar mode and includes functions for controlling temperature at the tip of the instrument and for monitoring impedance. It also has a unit for stimulation for provoking, localized, blocking and intraoperative test stimulation.

The provided text is a 510(k) summary for the STOCKERT NEURO N50 Radiofrequency Lesion Generator. This document establishes substantial equivalence to a predicate device, but it does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

Here's why and what information can be extracted:

• 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and performance data if available. However, such submissions do not always include detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would for novel, high-risk devices.
• "General Controls" Device: The STOCKERT NEURO N50 is classified as Class II, which generally means it's subject to "general controls" and "special controls." The document mentions general controls provisions of the Act but doesn't specify any "special controls" that would mandate a specific performance study design with acceptance criteria.

Information that can be extracted or inferred from the document regarding the device and its regulatory pathway:

• Device Name: STOCKERT NEURO N50
• Common Name: Radiofrequency Lesion Generator
• Classification Name: Generator, Lesion, Radiofrequency (21 CFR 882.4400, Product Code GXD, Class II)
• Predicate Device: NEURO N 50 LESION GENERATOR (510(k) No. K896450)
• Description: The system generates RF energy for delivery to neurological tissue to produce a lesion, interrupting electrical activity. It can be used in bipolar or unipolar mode, controls temperature, monitors impedance, and has stimulation functions.
• Indications for Use:
  1. Lesioning nerve tissue for functional neurosurgical procedures.
  2. Radiofrequency heat lesion procedures for the relief of pain.
  3. Stimulation procedures like provoking, localized, blocking, or intraoperative test stimulation.
• Regulatory Outcome: Found to be "substantially equivalent" to the predicate device.

In summary, the provided text does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance testing. For such information, one would typically need access to the actual design verification and validation reports, or a more comprehensive clinical study report, which are not part of this 510(k) summary.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

Ask a specific question about this device