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The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

The UltraPro S100 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities.

The UltraPro S100 system consists of the following major components:

• Main unit (also known as base unit or main base unit) with integrated control panel; ●
• Amplifier (3- or 4-channel);
• . Computer- laptop or desktop (with keyboard and mouse)
• Display Monitor (for desktop system)
• . Application Software (Natus Elite)

The UltraPro S100 has the following optional accessories/ components:

• Audio stimulators (Headphones or other auditory transducers)
• Visual stimulators (LED goggles or stimulus monitor)
• . Electrical stimulators (RS10 probes, stimulus probe with controls)
• Cart and associated accessories when using cart such as isolation transformer
• Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc.

The electrodiagnostics system is powered by a connection to mains.

The entire user interface of UltraPro S100 system consists of two major elements:

• The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite.
• The second means of interaction is the user interface elements on the hardware.

The UltraPro S100 is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The provided text is a 510(k) Summary for the Natus Ultrapro S100 device. While it describes the device's indications for use and compares its technological characteristics to predicate devices, it does not contain information about the acceptance criteria or the specific study that proves the device meets those criteria, such as a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. This document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and intended use.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used for test/training sets, data provenance, number or qualifications of experts, adjudication methods, or details about MRMC or standalone studies based on the provided text. The document is primarily a comparison of features and intended use.

The "Conclusion" section on page 14 states: "Verification and validation activities were conducted to establish the performance and safety characteristics of the UltraPro S100. The results of these activities demonstrate that the UltraPro S100 is safe, effective, and performance is substantially equivalent to the predicate devices." However, it does not elaborate on what these activities entailed or the specific criteria and results.

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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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The X-trodes System M is intended for prescription use only in the home or healthcare facility to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes System M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.

The X-trodes System M combines hardware, firmware, and software to acquire the following physiological signals: physiologic signal amplifier (EEG), electrooculography (EOG), surface electromyography (sEMG), electrocardiography (ECG), and accelerometer and gyroscope signals. It acquires physiological data through a data acquisition unit connected to electrode arrays patches, applied by a technician or patient to the patient. The data is recorded and transmitted to a cloud where it is converted to an EDF (European Data Format) format, suitable for analysis by third party software.

Here's a detailed breakdown of the acceptance criteria and the study that proves the X-trodes System M meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific, quantified clinical acceptance criteria for standalone diagnostic accuracy or effectiveness against a clinical gold standard. The "acceptance criteria" can be inferred from the "comparison of technological features" table (Table 1) and the discussion items (Sections 9.1-9.7), where the X-trodes System M's performance characteristics are compared to those of the predicate devices and relevant IEC standards.

The closest thing to a directly stated performance acceptance criterion, beyond comparisons to predicates and standards, is for the clinical study's primary endpoint:

• Primary Study Endpoint (Infered Acceptance Criterion): A high proportion of interpretable readings of each ExG signal (ECG, EEG, EMG, EOG) by the X-trodes System M that are equivalent to those of the reference device, with lower 98.75% confidence intervals higher than 60%.

Study Details

The document describes a clinical study to demonstrate the X-trodes System M's performance compared to an FDA-cleared clinical electrophysiology device.

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 55 subjects.
   • Data Provenance: The study was a "case-controlled study" conducted in a "clinic environment." The subjects were "adults who had been referred by either a neurologist for an electrophysiology test in the last 5 years." This suggests the data is prospective, collected specifically for this study, and likely from a single or limited number of clinical sites. The country of origin is not explicitly stated, but the applicant's address is Herzliya, Israel, which might imply the study was conducted there or in the US.

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

   • The study design describes a comparison against an "FDA-cleared clinical electrophysiology device" (referred to as X8). The "interpretability" and "equivalency" of XTR signals to the reference device were assessed.
   • The document does not explicitly state the number or qualifications of experts used to establish the ground truth or determine the "interpretable readings" and "equivalency" for the test set. It implies the reference device (X8) provided the comparison standard, and then the XTR signals were evaluated against that. It's unclear if independent human experts adjudicated the signals from both devices or if a software-based comparison was used for "equivalency."

3. Adjudication method for the test set:

   • The document states "The primary study endpoint was the proportion of interpretable readings of each ExG signal by the XTR that are equivalent to those of the reference device."
   • The specific adjudication method (e.g., 2+1, 3+1, none) is not detailed in the provided text. It's unclear how "interpretability" and "equivalency" were precisely determined.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a comparison of the X-trodes System M (the subject device) against another predicate device (X8) and focused on signal acquisition and display, not on the impact of an AI algorithm on human reader performance. The device "only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability." Therefore, there is no AI assistance component to measure the effect size for human readers.

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

   • Yes, in spirit, a standalone performance assessment was conducted for the device's signal acquisition capabilities. The study directly compared the signals acquired by the X-trodes System M to a reference device. It's "algorithm only" in the sense that the device itself acquires and processes the signals for display, and its performance (interpretable readings, RMS values) was directly evaluated without a human-in-the-loop task for diagnosis. However, it's crucial to note that the device does not perform analysis or provide diagnostic output; it just collects and displays signals.

6. The type of ground truth used:

   • The "ground truth" was established by an FDA-cleared clinical electrophysiology device (X8). The X-trodes System M's acquired physiological signals (EEG, EOG, ECG, EMG) were compared for "interpretable readings" and "equivalency" against the signals simultaneously acquired by the X8 device. This is a comparative ground truth against an established device, rather than a clinical outcome or pathology report.

7. The sample size for the training set:

   • The document does not provide information on a training set sample size. This makes sense as the device is stated to "only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals," implying it's not an AI/ML-driven device that typically requires a dedicated training set for diagnostic or analytical tasks. The performance evaluation focused on the device's ability to accurately capture and display raw physiological signals.

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

   • As no information on an AI/ML training set is provided (and the device is described as not performing analysis), there is no mention of how ground truth for a training set was established.

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The SafeOp 2: Neural Informatix System is intended for use in monitoring neurological status by recording 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.

The SafeOp™ 2: Neural Informatix System (SafeOp 2 System), formerly known as EPAD 2 (K182542), consists of the SafeOp head unit 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, and stimulating probe or clip contained in various kits. The SafeOp 2 System head unit contains a complete data acquisition system that has builtin stimulators, amplifiers, relays, A/D Converters, Digital Signal Processors, CPUs, and storage devices. The head unit interfaces with other equipment through communication ports and serves as the patient-contacting portion of the system where it is close to the surgical field. The head unit hardware contains an eight acquisition (input) channel and six-output channel Evoked Potential Stimulator that is used in the operating room to display nerve and muscle responses. The user can use these responses to diagnose insults to the peripheral or central nerves and to determine relative nerve location, proximity, and integrity data. The SafeOp 2 System application provides the primary graphical user interface and controls for the SafeOp 2 System. The application runs on a touchscreen tablet mobile device which connects to the head unit either via wired USB cable or wireless via Wi-Fi, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).

The provided text is a 510(k) summary for the SafeOp 2: Neural Informatix System. It primarily focuses on demonstrating substantial equivalence to a predicate device (EPAD™ 2 System, K182542) rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the typical sense of a clinical study measuring diagnostic accuracy or treatment efficacy. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various specifications. The "acceptance criteria" for this submission would broadly be that the device's specifications and performance are comparable to the predicate, with any differences not introducing new safety or effectiveness concerns.

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The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation.

Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.

· XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.

· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.

· Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.

· SSEP = The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.

• Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws. hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid treatment of disease.

Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.

This may include the following spinal implant procedures:

• Pedicle Screw Placement (cervical, thoracic, lumbar)

• Iliosacral screw placement

The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a control unit, as well as accompanying accessory components.

The Pulse NVM5 is a medical device that is intended for intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

Additionally, the Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in bending spinal rods (Bendini). Lastly, the Pulse NVM5 provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring.

Pulse LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging." LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.

Pulse Navigation is a stereotactic surgical application intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three dimensional space. The device provides real-time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in three dimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images are in the form of 3D intraoperative scan (CT or Cone Beam CT).

The reason for this submission is to update indications for the Pulse Navigation application and to introduce design modifications to hardware and software components of the Navigation application.

The information provided describes a 510(k) premarket notification for the NuVasive Pulse System. The document focuses on demonstrating substantial equivalence to predicate devices rather than a direct study proving the device meets specific acceptance criteria in the way a clinical trial might. However, it does mention nonclinical testing and comparison points that serve as "acceptance criteria" for demonstrating substantial equivalence.

Here's an attempt to extract and structure the requested information based on the provided text, while noting the limitations of a 510(k) summary regarding detailed study designs:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a formal table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format for clinical outcomes. Instead, it states that the device was found "substantially equivalent" based on various nonclinical tests meeting product and software requirements specifications and showing equivalence to predicate devices. The closest to a performance metric is for LessRay's image quality improvement.

2. Sample Size Used for the Test Set and Data Provenance

• LessRay Image Enhancement: A "side by side visual comparison of 30 image pairs with and without LessRay processing" was performed.
• Other tests (Tracking accuracy, 3D navigation registration, cadaver validation): The document does not specify the sample sizes for these test sets.
• Data Provenance: Not explicitly stated, but given the context of FDA submission, these would typically be internal company data from non-clinical lab settings, potentially using phantoms or cadavers. There is no mention of country of origin for the data or whether it was retrospective or prospective in detail, beyond being pre-market nonclinical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• LessRay Image Enhancement: Evaluated by "a human observer." No specific number or qualifications of experts (e.g., radiologist with 10 years of experience) are provided beyond "human observer."
• Other tests: Not specified.

4. Adjudication Method for the Test Set

• Not specified for any of the tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study is not explicitly mentioned or detailed in this 510(k) summary. The evaluation for LessRay was a "side by side visual comparison of 30 image pairs" by "a human observer," which does not constitute a full MRMC study for comparative effectiveness with human readers with and without AI assistance. The focus is on demonstrating substantial equivalence rather than comparative effectiveness.

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

• The document describes the "Pulse System" as a medical device for intraoperative monitoring and navigation, implying human-in-the-loop operation.
• For LessRay, the "image quality improvement" assessment itself appears to be a standalone evaluation of the algorithm's output (processed image vs. unprocessed image) that is then visually evaluated by a human. However, this is not a diagnostic performance study of the algorithm providing a final interpretation without human intervention.
• The "Tracking accuracy verification" and "3D navigation registration and tracking error verification" would primarily assess the standalone technical performance of the algorithms.

7. The Type of Ground Truth Used

• LessRay Image Enhancement: The ground truth for "image quality improvement" appears to be subjective visual assessment by a human observer.
• Navigation / Tracking Accuracy: For "Tracking accuracy verification per ASTM F2554-10" and "3D navigation registration and tracking error verification," the ground truth would likely be established by precise measurements from a known reference standard (e.g., precise phantom coordinates, highly accurate measurement systems).
• Cadaver validation for 3D navigation for pedicle screw placement: The ground truth would involve confirmatory imaging (e.g., post-placement CT scans) and potentially dissection to verify pedicle screw placement relative to anatomical structures.
• Electrical safety and EMC: Ground truth would be adherence to established industry standards like IEC 60601.

8. The Sample Size for the Training Set

• The document is a 510(k) summary focused on substantial equivalence and nonclinical performance testing. It does not provide information on the training set size for any AI/algorithm components within the system (e.g., LessRay's enhancement algorithm or navigation algorithms).

9. How the Ground Truth for the Training Set Was Established

• Since information on the training set itself is not provided, the method for establishing its ground truth is also not detailed.

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The Nexstim Navigated Brain Therapy (NBT®) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Nexstim Navigated Brain Therapy (NBT®) System is a non-invasive, repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder (MDD) without inducing seizure in patients who have failed one (1) antidepressant medication.

The Nexstim NBT System 2 is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.

The Nexstim NBT System 2 consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBT System 2 is provided by the software.

The Nexstim NBT System 2 combines magnetic resonance imaging-based (MRI-based), three dimensional (3D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy.

The Nexstim NBT System 2 software is used to import a patient's MR image slices to generate an accurate 3D model of the patient's head which can be electronically peeled back to reveal the anatomical structures of the brain.

The provided text is a 510(k) Premarket Notification from the FDA for the Nexstim Navigated Brain Therapy (NBT) System 2. This document is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed clinical study demonstrating the device's efficacy against specific, quantitative acceptance criteria in the manner one might see for a diagnostic AI.

The "acceptance criteria" discussed in this document are primarily related to technical specifications and regulatory compliance for a neurostimulation device, and the "study" proving it meets them refers to verification and validation activities against these technical standards, and a direct comparison to a predicate device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not explicitly detailed within this type of regulatory submission because the approval is based on demonstrating equivalence in technical characteristics and safety/performance, not on a novel clinical efficacy trial with specific, quantitatively defined "acceptance criteria" for a diagnostic algorithm's performance on a test set.

However, I can extract and present the information that is available and relevant to your request based on the provided document.

Acceptance Criteria and Device Performance (Based on Technical Equivalence)

The acceptance criteria here are implicitly met by demonstrating that the proposed device (Nexstim NBT® System 2 (Proposed Device)) is substantially equivalent to the predicate device (Tonica Electronik A/S Mag Vita TMS Therapy System w/ Theta Burst Stimulation ([K173620](https://510k.innolitics.com/search/K173620))) and the previously cleared version of its own device (Nexstim Navigated Brain Therapy (NBT®) System 2 ([K171902](https://510k.innolitics.com/search/K171902))), particularly for the new Intermittent Theta Burst (iTBS) Protocol. The "performance" is demonstrated by showing that the key technical characteristics are the same or comparable, and that compliance with relevant standards has been achieved.

Note: The performance here is primarily about technical specifications rather than statistical performance metrics (like sensitivity, specificity, AUC) for a diagnostic output, as this is a therapeutic rather than a diagnostic device, and the submission is focused on substantial equivalence.

Study Details:

1. Sample Size used for the Test Set and Data Provenance:

   • This submission is a 510(k) premarket notification primarily demonstrating substantial equivalence for a therapeutic device (rTMS system for MDD), specifically adding a new treatment protocol (iTBS).
   • The document does not describe a specific clinical "test set" or study in the sense of an independent data set used to evaluate a diagnostic algorithm's performance. Instead, it relies on:
     • Bench testing and verification/validation activities against technical standards (listed in the table above).
     • Comparison to a legally marketed predicate device (Tonica Electronik A/S / Mag Vita TMS Therapy System w/ Theta Burst Stimulation, K173620), which already had the iTBS protocol cleared.
     • Comparison to its own previously cleared device version (K171902) to show that existing features remain unchanged or are consistent.
   • Therefore, there's no "sample size" for patients/cases in a typical AI/diagnostic study sense within this document for a "test set." The document focuses on technical and safety equivalence.

2. Number of Experts used to establish the Ground Truth for the Test Set and Qualifications of those Experts:

   • Not applicable in the context of this 510(k) submission. This is not a study assessing the diagnostic performance of an AI against expert ground truth. The "ground truth" for this device's function is its ability to deliver the specified magnetic stimulation parameters accurately and safely, and for the clinical efficacy of this type of therapy for MDD, which is established by larger clinical trials for the class of devices and specific protocols (e.g., those reviewed for the predicate device).

3. Adjudication Method for the Test Set:

   • Not applicable. No external "test set" requiring expert adjudication is described.

4. 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. This device is a therapeutic rTMS system, not a diagnostic AI system intended to assist human readers. Therefore, an MRMC study is not relevant to this submission.

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

   • Not applicable in the traditional sense of a diagnostic algorithm. The device itself (the Nexstim NBT System 2) operates based on software control and delivered TMS pulses. Its "standalone performance" is implicitly demonstrated through the various verification and validation activities (software, electrical safety, EMC, bench testing), which confirm it functions according to its predetermined specifications, independently of a human operator, in terms of delivering the therapy. The clinical use always involves a trained medical professional.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this submission is multi-faceted, aligning with the nature of a therapeutic device and a substantial equivalence review:
     • Technical Specifications: The core "ground truth" for the device itself is its adherence to specified physical parameters (magnetic field intensity, frequency, pulse length, etc.) and compliance with recognized industry standards (IEC, ISO, FDA guidance) for safety and performance. This is verified through bench testing and engineering evaluations.
     • Predicate Device Performance: The "ground truth" for clinical effectiveness of the iTBS protocol is based on the established performance of the predicate device (K173620) which already had clearance for this protocol. The submission argues that since the proposed device's technical characteristics for delivering iTBS are equivalent, its clinical effect would also be equivalent.
     • Clinical Effectiveness of rTMS for MDD: The broader "ground truth" for the treatment of Major Depressive Disorder with rTMS is established by clinical outcomes data from pivotal studies that led to the approval of the predicate device and other similar rTMS systems for MDD. This document refers to the established indication for use for rTMS in MDD, rather than presenting new clinical trial data for this specific device's efficacy beyond the established equivalence.

7. The sample size for the training set:

   • Not applicable. This document describes a medical device seeking 510(k) clearance, not an AI/machine learning algorithm undergoing training with a specific dataset. The software is developed and verified via traditional software engineering processes, not "trained."

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

   • Not applicable. As there is no "training set" for an AI/ML algorithm, no ground truth needed to be established in that context.

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The EPAD 2 system is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous, lumbar, thoracic, and cervical surgical procedures.

The EPAD 2 System consists of the EPAD 2 Headbox and power supply, a tablet computer, electrodes, stimulating probe or clip and cables. The Headbox is responsible for the stimulation and acquisition of signals for the intraoperative neurophysiologic monitoring (IONM) functions. The Headbox contains onboard firmware and is mounted on the operating room (OR) bed by clipping it to the bed side bar. The EPAD application provides the primary graphical user interface and controls for the EPAD II System. The application runs on a touchscreen tablet mobile device which connects wirelessly or via a wired USB cable to the Headbox. The application serves as the interface to the EPAD Headbox, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).

The provided text primarily focuses on the 510(k) clearance of the EPAD 2 System, demonstrating its substantial equivalence to predicate devices rather than presenting data from a specific study designed to meet acceptance criteria for novel performance claims. Therefore, much of the requested information regarding acceptance criteria, reported performance, and study details is not explicitly available in the provided document.

However, I can extract information related to the device's characteristics and the types of testing performed to support its substantial equivalence.

Here's an analysis based on the given document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in the way one would expect for a study proving new performance claims. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data mentioned are related to meeting functional, system, and software requirements, and compliance with safety standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This indicates that:

• There was no clinical test set in the traditional sense for evaluating novel performance claims against acceptance criteria.
• The data provenance, sample size, or retrospective/prospective nature of a clinical study are not specified because such a study was not the basis for clearance.
• The performance data cited are from nonclinical performance testing, EMC, electrical safety, and usability testing, which typically involve device-level assessments rather than patient-based test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Since there was no clinical test set for evaluating novel performance claims, there is no information provided regarding experts establishing ground truth for such a test set. The substantial equivalence determination relies on comparisons to already cleared predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring ground truth adjudication for novel performance claims was used as the basis for this 510(k) clearance.

5. 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 EPAD 2 System is an Evoked Response Electrical Stimulator used for neuromonitoring, not an AI-assisted diagnostic imaging device that would typically involve a multi-reader multi-case study or "human readers improve with AI" metrics.

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

This concept is not directly applicable to the EPAD 2 System. The device is an instrument used by qualified medical personnel for neuromonitoring and does not operate as a standalone "algorithm only" device for making diagnoses or performing interventions without human-in-the-loop interaction. Its function is to acquire and display physiological signals for interpretation by a clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the nonclinical performance, EMC, electrical safety, and usability testing, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For functional, system, and software requirements, and for EMC/electrical safety, the device's performance is compared against pre-defined engineering specifications and national/international standards (e.g., IEC 60601-1).
• User feedback/observation: For usability testing, the "ground truth" is typically the observation of user interaction and compliance with usability engineering principles, identifying potential use errors or safety concerns.

There is no mention of pathology or outcomes data as ground truth for this 510(k) submission, as it explicitly states that clearance is "not based on an assessment of clinical performance data."

8. The sample size for the training set

Not applicable. This device is cleared through the 510(k) pathway which demonstrates substantial equivalence to predicate devices. It is not an AI/ML device that typically requires a large "training set" in the machine learning sense for its core functionality. While there might be firmware/software development which internally used data, the submission does not detail such a training set for regulatory review.

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

Not applicable, as no training set in the AI/ML context is described or relevant for this 510(k) cleared device.

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The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.

· XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.

· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.

· Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· Twitch Test (Train of Four) – The Twitch allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.

· SSEP = The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.

· Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System.

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.

This may include the following spinal implant procedures:

o Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine)

o Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral Approach)

The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a Patient Module (PM) and computer, as well as accompanying accessory components.

The Pulse NVM5 is a medical device that is intended for intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

Additionally, the Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in bending spinal rods (Bendini). Lastly, the Pulse NVM5 provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring.

LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging." LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.

LessRay System has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. LessRay System uses this information to aid the user in positioning the instrument.

Pulse Navigation is a stereotactic surgical application intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three dimensional space. The device provides real-time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in three dimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images can be either 2D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT).

The NuVasive Pulse System is comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The provided text details the indications for use and technological characteristics but lacks specific quantitative acceptance criteria or detailed study results for all components. However, it does mention nonclinical testing and a specific study related to the LessRay component.

Here's a breakdown of the requested information based on the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

For the LessRay image quality evaluation:

• Sample Size (Test Set): 30 image pairs.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

For the overall Pulse System nonclinical testing:

• Sample Size (Test Set): Not specified for each test.
• Data Provenance: Not specified beyond being "nonclinical testing." Cadaver validation implies ex-vivo data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the LessRay image quality evaluation:

• Number of Experts: Described as "a human observer." It's unclear if this was a single person or multiple individuals, and their qualifications are not provided (e.g., radiologist with X years of experience).

For other components of the Pulse System:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

For the LessRay image quality evaluation:

• Adjudication Method: "Side by side visual comparison." No mention of formal adjudication like 2+1 or 3+1.

For other components of the Pulse System:

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No explicit mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to measure how much human readers improve with AI vs. without AI assistance. The LessRay evaluation mentions "a human observer" comparing image pairs, which suggests a single observer, not an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The documentation mentions various software functionalities and algorithms (e.g., XLIF Detection, Basic & Dynamic Screw Test, LessRay's averaging algorithm, contrast/brightness enhancement). Nonclinical testing involved "software validation" and "tracking accuracy verification." This implies that standalone algorithm performance was assessed as part of the overall system validation, but specific results for the algorithm only (without human-in-the-loop) are not provided separately or in detail showing what performance was achieved for each algorithm.

7. The Type of Ground Truth Used

• For LessRay's image quality, the ground truth was based on a "human observer's" subjective visual perception of improved clarity, contrast, and noise level in comparison to unprocessed images.
• For the navigation components, "cadaver validation" was performed for 2D and 3D navigation for pedicle screw and interbody device placement, suggesting anatomical accuracy as a ground truth.
• For other components (NVM5 functionalities, tracking accuracy), the ground truth would likely be established through engineering measurements against design specifications and physical tests.

8. The Sample Size for the Training Set

• The document primarily describes validation and verification testing for regulatory submission (510(k)). It does not provide details on sample sizes for any training sets used for developing the algorithms within the Pulse System.

9. How the Ground Truth for the Training Set Was Established

• Since details on training sets are not provided, the method for establishing ground truth for training data is also not available in this document.

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The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The subject device, the Neuro Omega System incorporated the installed HaGuide software is also intended:

-To monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis of neuromuscular disease (EMG).

-To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG).

-To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.

-To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.

The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.

The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular disease (EMG).

The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.

The subject device, the Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.

The subject device, the Neuro Omega System incorporated the installed HaGuide software as a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation.

The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary. The tool presents real time graphs of power spectrum density and RMS of each region.

The Neuro Omega System, equipped with the HaGuide software, is designed to assist neurosurgeons in functional neurosurgery, specifically aiding in the placement of depth electrodes by accurately detecting the Sub Thalamic Nucleus (STN) region.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than explicitly listing quantitative acceptance criteria for the HaGuide software's performance, as would be typical for an AI/ML device approval under current guidelines. However, the one clear performance metric and its result are presented in the clinical performance test:

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The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general. Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Natus VikingQuest is intended to be used by a qualified healthcare provider.

The Natus VikingQuest is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.

The provided text describes the 510(k) premarket notification for the Natus VikingQuest, a diagnostic electromyograph. The information focuses on its substantial equivalence to predicate devices and adherence to various medical device standards. However, it does not contain specific details about acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test sets, data provenance, ground truth establishment, or clinical study designs (like MRMC or standalone performance).

The document primarily outlines the regulatory compliance, technological characteristics, and intended use of the device, rather than detailed clinical performance evaluations against specific acceptance criteria.

Therefore, for aspects related to acceptance criteria and a study proving device performance, the information is largely absent in the provided text.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified. The document describes engineering and regulatory compliance testing rather than clinical study data.

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

• Not applicable as no clinical test set or ground truth establishment by experts for performance against a diagnosis is described. The "ground truth" mentioned pertains to compliance with engineering and safety standards.

4. Adjudication method for the test set:

• Not applicable as no human adjudication of clinical results is described.

5. 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:

• No mention of an MRMC study or AI assistance. The Natus VikingQuest is a diagnostic electromyograph for acquiring, displaying, analyzing, and reporting electrophysiological information, not an AI-driven interpretation system.

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

• The document describes a medical device (electromyograph) for use by a qualified healthcare provider. It does not describe a standalone algorithm or AI performance. The performance verified is for the entire device as a system.

7. The type of ground truth used:

• For the regulatory and engineering tests (biocompatibility, software, electrical safety, EMC, usability), the "ground truth" is compliance with established international standards (ISO, IEC, AAMI/ANSI) and FDA guidance documents. There is no mention of pathology, expert consensus on clinical findings, or outcomes data in the context of the device's diagnostic accuracy proving.

8. The sample size for the training set:

• Not applicable. The document describes a medical device, not an AI/machine learning algorithm with distinct training and test sets in the typical sense. Software development was "rigorously verified and validated consistent with FDA guidance documents and standards," implying traditional software testing, not machine learning model training.

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

• Not applicable, for the same reasons as point 8.

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