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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.

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