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The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

• Somatosensory evoked potentials (SSEP)
• Motor evoked potentials (MEP),
• . Train-of-four neuromuscular junction (TO4),
• Triggered electromyography (tEMG) and ●
• . Free run electromyography (sEMG)

The provided text does not contain detailed information about specific acceptance criteria for the device's performance, nor does it describe a study that rigorously proves the device meets such criteria through a clinical validation or similar performance evaluation.

The document is a 510(k) premarket notification summary for the "SafeOp 3: Neural Informatix System." Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (SafeOp2: Neural Informatix System, K213849, and reference device Cascade IOMAX Intraoperative Monitor, K162199), rather than to present a full clinical performance study with defined acceptance criteria and detailed results.

Here's a breakdown of what the document does say, and what it lacks in relation to your request:

What the document provides:

• Device Name: SafeOp 3: Neural Informatix System
• Intended Use/Indications for Use: Monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ) during various surgical procedures.
• Technological Comparison: A table comparing the SafeOp 3 System to predicate and reference devices, focusing on technical specifications like monitoring modalities, amplifier channels, stimulation parameters (voltage, current, pulse duration, repetition rate), and filter ranges. This comparison primarily aims to establish that the differences in technology do not raise new questions of safety or effectiveness.
• Performance Data (Non-clinical): Mentions that "Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements." It also states "EMC and Electrical Safety Testing... was performed to ensure all functions... are electrically safe, and comply with recognized electrical safety standards." Usability testing was also performed.
• Clinical Information Disclaimer: Explicitly states, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

What the document lacks significantly for your request:

• A table of acceptance criteria and reported device performance: This is the most significant omission for your request. The document details technical specifications and comparisons but does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) against pre-defined acceptance thresholds for any of its functionalities (MEP, SSEP, EMG, NMJ). The performance data mentioned are non-clinical (functional, system, software, EMC, electrical safety, usability), not clinical performance metrics.
• Sample size used for the test set and data provenance: Since specific clinical performance studies are not detailed, this information is not provided.
• Number of experts used to establish ground truth and qualifications: Not applicable as a clinical ground truth establishment process for performance evaluation is not described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned or detailed.
• Standalone (algorithm only) performance: While the device is an "algorithm only" in a sense (it processes physiological signals), its performance isn't quantified in a standalone clinical evaluation or comparative study.
• Type of ground truth used: No clinical ground truth is described for performance evaluation.
• Sample size for the training set: Not applicable, as this is related to AI/ML development and training, which is not described. The device is a neuromonitoring system, not explicitly stated to be an AI/ML device in the context of this submission.
• How the ground truth for the training set was established: Not applicable.

Why this information is missing:

The FDA 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate, without necessarily requiring new clinical trials or detailed performance studies if the technological differences are minor and well-understood. The focus is on showing that any differences do not introduce new safety or effectiveness concerns.

In summary, based solely on the provided text, I cannot complete the table of acceptance criteria or describe a study that proves the device meets these criteria in a clinical performance context. The document focuses on demonstrating substantial equivalence through technical comparison and non-clinical testing, rather than presenting clinical performance metrics.

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