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The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface.

The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.

The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

The NM-01/CPT neurometer is a noninvasive device intentity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

The NEUROMETER NM-01/CPT is a unique neurodiagnostic device that painlessly evaluates the functioning of small unmyelinated (C, small myelinated (A) and large myelinated (A) sensory nerve fibers at any cutaneous site by determining neuro selective sensory nerve conduction threshold. The electronic unit emits non-aversive transcutaneous electrical stimuli through a pair of special noninvasive electrodes in three fixed frequency ranges (thick myelincoated fiber 250Hz, thin myelin-coated fiber 2000Hz) with a manually adjustable current value. The emitted stimulus pulses canbe changed between 0.01 and 9.99 mA and their values qiven by the software are in CPT (Current Precipitation Threshold) values accepted in clinical practice (1CPT = 0.01mA). The test method is sensitive to both hyperesthetic abnormalities, and has more than 800 peer reviewed research publications documenting its diagnostic capabilities. The device can measure sensory nerve function at any cutaneous site including mucosal surfaces such as the bladder and the measures are not affected by skin temperature, edema or electromag-netic interference unlike traditional electro-diagnostic and biopsy procedures. The conducted tests are painless, noninvasive and non-aversive procedure is easy to perform and safe and harmless however it is only for profession clinical use. The evaluation of the tests result could only be approved by a medical doctor but the tests could be conducted by a trained assistant.

The provided text describes a 510(k) premarket notification for the NM-01/CPT neurometer (K240189) and its substantial equivalence to predicate devices. It includes a summary of non-clinical testing performed.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a numerically quantified target, but the study implies an acceptance range for the ratio of measurements between the NM-01/CPT neurometer and the predicate device (Neurometer) to be within 10%.

For CPT 10, the mean of the ratio is 1.109, with a 90% confidence interval of (1.0531; 1.1648), meaning the two measurements cannot be considered equivalent within the 10% limit for CPT 10. However, the document states such values are "not expected in the population under study." |

Conclusion on Acceptance: The device generally met the implicit acceptance criteria of equivalence within a 10% limit, with a noted exception for CPT 10 values, which the submitter claims are not clinically relevant for the target population.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The text mentions "Bench testing was performed on the NM-01/CPT neurometer measured values with the results of the Neurometer used in clinical practice," but it does not specify the number of resistance measurements or CPT measurements performed for this comparison.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study is described as "Bench testing," implying it was conducted in a controlled environment as opposed to a clinical trial with human subjects.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The study described is a bench test comparing the performance of the new device against a predicate device, not involving human interpretation for establishing ground truth regarding a medical condition.

4. Adjudication Method

Not applicable for a bench test comparing device measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The study was a bench test comparing the device's measurements to a predicate device.

6. Standalone Performance Study

Yes, a standalone performance study (bench testing) was done. The NM-01/CPT neurometer's measured values were compared against the results of the legally marketed predicate device (Neurometer). This comparison assesses the algorithm/device's technical performance.

7. Type of Ground Truth Used

The "ground truth" for this bench test was the measurements obtained from the predicate device, the "Neurometer used in clinical practice." This means the new device's performance was evaluated against an established and accepted device's output.

8. Sample Size for the Training Set

Not applicable. This document describes a performance evaluation of a device, not the development of a machine learning algorithm that typically involves a training set. The device appears to be an electrodiagnostic tool that directly measures nerve conduction thresholds, rather than an AI/ML diagnostic system.

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

Not applicable, as there is no mention of a training set or machine learning algorithm.

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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 Mediracer NCS is intended to measure sensory and motor neripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.

The Mediracer NCS is a hand-held NCS Device to stimulate and record the nerve responses from patient. The NCS Device is connected to the disposable surface electrodes with cables provided with the NCS Device. The NCS Device communicates via Bluetooth with a computer which is using The Mediracer Analysis Center (MAC) software. The computer uses the MAC software to store and handle the patient measurement data. With the NCS Device comes a charger and a docking station for charging the NCS Device. Also, solution includes a test module for checking the functionality of the whole test system.

The Mediracer NCS is a nerve conduction velocity measurement device. The provided text outlines the performance data for the device, including bench testing and clinical studies, to support its substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the document focuses on demonstrating substantial equivalence to a predicate device and high agreement with traditional nerve conduction studies. The "performance data" section primarily describes the results of studies rather than pre-defined acceptance criteria with specific numerical targets typical for a 510(k) submission.

However, based on the summary provided, we can infer the reported device performance:

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

The provided text describes two clinical studies used for performance evaluation, which can be considered the test sets.

• Finnish Multicenter Study:

  • Sample Size: 194 patients and 95 healthy control volunteers.
  • Data Provenance: Finland (multicenter study).
  • Retrospective or Prospective: The description strongly suggests a prospective study ("recruited patients," "went through a clinical examination, Mediracer NCS measurement and the traditional NCS").

• United Kingdom Study:

  • Sample Size: 63 patients (selected from 104 referrals).
  • Data Provenance: United Kingdom (Leicester Carpal Tunnel Service).
  • Retrospective or Prospective: Description indicates patients "were recruited from the normal referral stream," "fulfilled the clinical CTS diagnosis after symptom inquiry and clinical assessment," and "went through clinical assessment, Mediracer NCS measurement and the traditional NCS," suggesting a prospective study.

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

The text states that in both clinical studies, participants underwent "traditional nerve conduction studies (NCS)" and "clinical assessment." The "traditional NCS" likely serves as the ground truth. It also mentions that "The data measured is reviewed and interpreted by a specially trained physician or specialist in neurophysiology."

• Number of Experts: Not explicitly stated how many distinct experts were involved in interpreting the traditional NCS for ground truth establishment within the context of the studies. It refers to "a specially trained physician or specialist in neurophysiology" in general terms for interpreting Mediracer NCS data, but does not specify for the ground truth of the studies.
• Qualifications of Experts: Assumed to be "specially trained physician or specialist in neurophysiology," as they are the ones who perform and interpret traditional NCS. Specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The adjudication method for determining the true disease status based on the "traditional NCS" is not explicitly described. It only states that the traditional NCS was performed. It doesn't mention if multiple readers reviewed the traditional NCS, or if there was a consensus process (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not done. The study compares the Mediracer NCS device (which is also used by humans) against traditional NCS devices, not the effect of AI on human reader performance. The Mediracer NCS itself is a measurement device, and while it has accompanying software (MAC), the study is evaluating the device's diagnostic capability, not an AI's interpretative assistance to a clinician.

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

• Standalone Performance: No, a standalone (algorithm only) performance study was not done in the context of an AI algorithm. The Mediracer NCS is a device that requires a human operator ("used by physician or by technician on the order of physician") to take measurements, and a physician to review and interpret the data. The "Mediracer Analysis Center (MAC) software" is for storing and handling data, not an AI for autonomous interpretation or diagnosis.

7. The Type of Ground Truth Used

The ground truth used in the clinical studies was based on traditional nerve conduction studies (NCS) and clinical assessment for diagnosing Carpal Tunnel Syndrome (CTS). This would fall under expert consensus/clinical diagnosis derived from established diagnostic procedures.

8. The Sample Size for the Training Set

The document does not mention a training set for the Mediracer NCS device. This is likely because the Mediracer NCS is presented as a measurement device, not an AI/machine learning algorithm that requires a training phase. Its equivalence is established through direct comparison to existing measurement techniques and devices.

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

Since no training set is mentioned for an AI/machine learning model, the method for establishing its ground truth is not applicable here.

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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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The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited stimuli. The acquired data are necessary to perform somatosensory. auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures.

Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, and stores the electrical activity of the nervous system in response to the stimulation.

EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head.

Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions.

TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex.

Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle.

Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.

Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, and stores the compound muscle action potential amplitude fade for analysis.

SpO2: IOMAX measures and displays oxygen saturation and heart rate information. Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room.

IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

The IOMAX is a multimodality intraoperative neuromonitoring (IONM) system. It consists of Cadwell custom hardware, a standard laptop or desktop personal computer (PC) running a standard off-the-shelf (OTS) operating system (OS), and Cadwell custom software.

The modalities recorded, measured and displayed by the IOMAX are:

• . Evoked potential (EP) in the form of:
  • Brainstem auditory (BAEP): O
  • Visual (VEP); and O
  • Somatosensory (SSEP). O
• Transcranial electrical motor evoked potential (TcMEP).
• Electromyography (EMG). ●
• Triggered EMG.
• Electroencephalogram (EEG). ●
• Nerve conduction studies.
• Train of four (TOF). ●
• SpO2 and heart rate values. ●
• Threshold mode. ●
• Cortical stimulation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Cadwell IOMAX Intraoperative Monitor:

Acceptance Criteria and Reported Device Performance

The provided document describes the Cadwell IOMAX Intraoperative Monitor, an electroneurodiagnostic device. The acceptance criteria are broadly focused on the device's technical performance, safety, and compliance with various medical device standards. The document does not present specific quantitative acceptance criteria or reported performance values in a distinct table format. Instead, it states that "Test results indicate that the IOMAX complies with its predetermined specifications and the applicable standards." and "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard."

However, we can infer the categories of acceptance criteria based on the performance testing summary. The reported device performance is generally a statement of compliance.

Study Details:

The provided document summarizes various tests rather than detailing a single "study" as one might expect for a clinical trial. However, it does outline the testing performed to demonstrate compliance.

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

   • Biocompatibility: Not explicitly stated as a "sample size" for a test set in the clinical sense. The verification was on "component materials" of accessories. Data provenance is implied to be laboratory testing of materials.
   • Software, Electrical Safety, EMC, Bench Performance: Not applicable in terms of patient sample size. These involve engineering and laboratory testing of the device itself.
   • Clinical Performance (SpO2): The document states "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard [ISO 80601-2-61:2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment]". This standard defines requirements for pulse oximeters, which would necessitate testing on human subjects. However, the specific sample size for this clinical testing is not provided in the given text. The data provenance is clinical testing against a standard. The country of origin is not specified.

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

   • This information is not provided in the document. The testing described is primarily technical compliance with standards, and clinical performance for SpO2 which refers to a standard directly. There is no mention of independent expert review or ground truth establishment in the traditional sense for diagnostic accuracy.

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

   • This information is not provided and is unlikely to be applicable for the types of compliance testing described here. Adjudication methods are typically used for medical image interpretation or diagnostic accuracy studies involving human readers.

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 MRMC comparative effectiveness study was done or mentioned. This device is an intraoperative monitor and stimulator; it is not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases with or without AI assistance. Therefore, no effect size of human improvement with AI assistance is applicable or provided.

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

   • The IOMAX is an electroneurodiagnostic device that acquires and displays physiological data. Its "performance" is based on the accuracy and reliability of its measurements and stimulation. The testing described (electrical safety, EMC, bench, and clinical for SpO2) assesses the device's inherent function, which is essentially "standalone performance" in the sense that the device directly performs the measurement or stimulation. It doesn't involve an "algorithm" in the AI sense, but rather the hardware and software's ability to accurately capture and present physiological signals or deliver specific stimuli.
   • The clinical performance for SpO2 (compliance to ISO 80601-2-61) is a test of the device's standalone accuracy in measuring oxygen saturation and heart rate.

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

   • For the technical compliance tests (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" is defined by the requirements of the specified industry standards (e.g., ISO 10993-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60068, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-6, IEC 62366). The device's output is compared against the expected performance defined by these standards.
   • For the clinical performance testing for SpO2, the ground truth would be established by a reference method or device as required by ISO 80601-2-61, which typically involves comparing the pulse oximeter's readings against arterial blood gas analysis results.

8. The sample size for the training set:

   • This information is not applicable as the device is not described as an AI/machine learning device that requires a training set in the conventional sense. The "training set" for software development would be the requirements and specifications used during its creation, rather than a dataset for statistical model training.

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

   • As the concept of a "training set" for an AI model is not applicable here, the establishment of ground truth for such a set is also not applicable. The software's "ground truth" during development would be its specified functional requirements.

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Cadwell Sierra Summit:

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Cadwell Sierra Ascent:

Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

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

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.

The Sierra Summit provides a variety of test protocols spanning the various test modalities above.

The Cadwell Sierra Summit consists of the following major components:

• Sierra Summit console base unit with integrated control panel ●
• Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
• Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
• Display monitor ●
• Summit software

The Sierra Summit has the following optional accessories/components:

• Remote Head Box (for 3-12 channel amplifier) ●
• StimTroller (Hand Held Electrical Stimulator)
• Electrical Stimulator Switch Box ●
• Footswitch (single) ●
• Visual Stimulators (LED Goggles, LCD Checks)
• VEP Calibration Sensor
• Headphones or other auditory transducers
• Reflex Hammer
• Temperature Probe ●
• Cart
• Isolation Transformer or Medical Grade Power Strip
• Printer

The provided text is a 510(k) Summary for the Cadwell Sierra Summit and Cadwell Sierra Ascent devices. It details the device descriptions, indications for use, and a summary of technical characteristics compared to predicate devices, along with performance testing. However, it does not include specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) or detailed results from studies designed to prove the device meets such criteria.

The "Performance Testing - Bench" section mentions conformance to various standards and internal requirements, concluding that "Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards." This is a general statement of compliance, not a presentation of performance data against specific acceptance criteria.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

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

This information is not provided in the document. The document states compliance with "predetermined specifications and applicable standards" for various tests (biocompatibility, software, electrical safety, EMC, and bench performance), but it does not list specific numerical acceptance criteria or quantitative performance results for the device.

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

This information is not provided in the document. The document describes "Performance Testing - Bench" and "Verification and validation activities," but it does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective).

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):

This information is not provided in the document. The document refers to the device being used by "qualified medical practitioners" for diagnosis but clarifies that the device "does not provide any diagnostic conclusion about the patient's condition to the user." There is no mention of experts establishing ground truth for any test sets related to diagnostic performance.

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

This information is not provided in the document. There is no mention of an adjudication method.

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:

This information is not provided in the document. The device is a diagnostic electromyograph for measuring electrophysiological data and supporting the diagnosis of neuromuscular diseases. It is not described as an AI-assisted device for interpretation or diagnosis to be used "with AI vs without AI assistance" by human readers in the context of improving effectiveness. The document states, "This device does not provide any diagnostic conclusion about the patient's condition to the user."

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

This information is not provided in the document. Given the nature of the device (electromyograph for data acquisition and analysis, not providing diagnostic conclusions), it typically functions as a tool for a human practitioner, rather than as a standalone diagnostic algorithm.

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

This information is not provided in the document. As no specific performance studies against a diagnostic "ground truth" are detailed, the type of ground truth is not mentioned.

8. The sample size for the training set:

This information is not provided in the document. No training data or training set sample size is mentioned, as the device is not an AI/machine learning model in the sense of requiring a training set for diagnostic outcome prediction.

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

This information is not provided in the document. As no training set is mentioned, the method for establishing its ground truth is also not.

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The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

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

· CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.

· TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

· Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

• SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used. oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, endtidal carbon dioxide of respiratory gas information is automatically measured and displayed.

• Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.

· Remote reader – The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children of all ages.

The Neuromaster G1 MEE2000 Neural Function Measuring System is a compact and multi-functional system for continuous monitoring of brain and neural pathways intraoperatively and in critical care areas. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of the extremities, SpO2 and ETCO2. The system also measures and displays nerve conduction time by applying a stimulus to a patient's peripheral nerve. The system includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The system uses electrical stimulus, visual stimulus, or sound stimulus in evoked responses measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The system applies an electrical stimulus to a patient through skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting light pattern or to apply a brief light stimulus for use in evoked response measurements or electroencephalogram activation. The system may measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The system can be used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

The system can be connected to SpO2 and ETCO2 sensors to display the patient's oxygen saturation values as measured by pulse oximetry and CO2 values respectively throughout the procedure.

The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trend graph with waveform annotations (events). The acquired waveforms with the measurement data can be saved to a large capacity storage media. The data can be printed directly on paper, printed to portable document format (pdf), and/or archived to other locations.

The Neuromaster G1 MEE2000 System consists of at minimum a main unit (DC-200B), an amp unit (JB-232B), one breakout box (JB-210B), four stimulation pods [JS-201B(A), JS-202B (B), JS-203B (C), JS-204B (D)], and a computer (CC-201BK) with specific software. There are several standard and optional accessories such as cables, connectors, SpO2 probes, ETCO2 sensors, and various types of electrodes and leads.

Here's a breakdown of the acceptance criteria and study information for the Neuromaster G1 MEE2000 Neural Function Measuring System, as derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria and explicitly defining the new device's performance against them. Instead, the performance characteristics of the Neuromaster G1 MEE2000 System are presented in comparison to its predicate device (Neuromaster MEE1000 System) and other reference predicates. The "acceptance criteria" here are implicitly the performance specifications of the predicate devices, which the new device aims to meet or exceed where noted.

I will present a selection of key characteristics to illustrate this comparison format. Please note that the document contains a very extensive table (Table 3) outlining numerous characteristics; this is a summary of some of the most relevant ones to demonstrate the device's technical specifications and how they align with or improve upon predicates.

Table: Acceptance Criteria (Predicate Performance) and Reported Device Performance (Neuromaster G1 MEE2000)

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The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.)

The device is intended to be used in the clinical and hospital environment (including the hospital room, emergency room, intensive care unit, neuro-intensive care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles

Galileo NT Line is a software package running on a Personal Computer under Windows Operative System. This package is devoted to the complete management of various exams in the Neurodiagnostic field of application, as electroencephalography, electromyography, Evoked Potentials etc.

The product is essentially a suite of applications dedicated to the comprehensive management of neurological diagnostics in a Department of Neurophysiology, etc. ... starting from the patient's acceptance, the execution of specific tests, and finally to the production of the exam reports. The package is substantially made by a common "platform" and by various independent modules, each of which is devoted to a particular application (EEG, Video EEG, EMG, EP, ICU, etc.). All the parts of the package together with the related User Documentation are residing on the same distribution media (a DVD).

As illustrated by figure 1 below, GALILEO NT Line (simply Galileo NT in other documents of this submission) is a "software only device" that can control and acquire data from a series of (FDA cleared) Amplifier platforms developed by EBNeuro for the Neurodiagnostic field and specifically :

• 1. BE micro (K093728)
• 2. BE Plus LTM (K121986)
• 3. Nemus 2 (K133517)

For each of the above devices, Galileo NT provides the appropriate "software interface" module in order to allow the control of the Amplifier (and of all the accessories eventually provided with it, as, for example, the Evoked Potential stimulators embedded in the Nemus 1 and 2 hardware) and in order to collect the acquired data. The data, once acquired from the amplifier, are "passed" to the specialized module for successive handling as display, measure, printing, trending, archiving and so on.

The provided text is a 510(k) premarket notification for the EB Neuro Galileo NT Line software. This document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format specified (a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for testing/training).

Specifically:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the software's features and intended use to predicate devices, not on quantitative performance metrics with associated acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as a performance study of this nature is not described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. This is a software package for recording and displaying physiological data, not an AI-powered diagnostic tool that assists human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a software suite for managing neurodiagnostic exams, not an algorithm with standalone diagnostic performance.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable, as no algorithm training is described for diagnostic performance.
• 9. How the ground truth for the training set was established: Not applicable.

The document explicitly states under "Summary of Clinical Tests": "No clinical tests were performed." This further confirms that no performance study as described in your request was conducted for this 510(k) submission. The FDA clearance was based on substantial equivalence to existing devices and compliance with relevant industry standards (ISO 14971, IEC 62304, IEC 62366) for design and development, rather than a clinical performance study.

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The Synergy Focus 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 Synergy Focus 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 Synergy Focus 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 Synergy Focus is intended to be used by a qualified healthcare provider.

The Natus Synergy Focus (Synergy Focus) 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). Synergy Focus provides a variety of tests spanning the various modalities.

The Synergy Focus consists of the following major components:

• Console base unit with integrated control panel;
• Amplifier (with three non-switched amplifier channels);
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Synergy Software.

The Synergy Focus optional accessories/components consists of the following:

• Stimulator probes (RS 10 probe, Stimulus Probe with controls)
• Footswitches (triple)
• LED goggles
• Headphones or other auditory transducers
• Patient response button
• Cart
• Isolation transformer
• Printer.

The Natus Synergy Focus is an electromyograph (EMG) device intended for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance relies heavily on demonstrating substantial equivalence to predicate devices (K112052 CareFusion Nicolet EDX with Viking Software and K120979 CareFusion Nicolet EDX with Synergy Software). Therefore, the "acceptance criteria" are primarily defined by the performance characteristics of these predicate devices, and the "reported device performance" demonstrates that the Synergy Focus either matches or improves upon these characteristics, or where there are differences, they do not raise new questions of safety or effectiveness.

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

The provided 510(k) summary does not explicitly state a sample size for a test set or data provenance in the context of clinical performance or AI/algorithm performance.

Instead, the submission relies on demonstrating substantial equivalence to its predicate devices (K112052 and K120979) through:

• Comparison of technical characteristics.
• Non-clinical performance testing (biocompatibility, software validation, electrical safety, EMC, and bench testing to applicable standards like IEC 60601-2-40).
• The explicitly stated conclusion that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness."

This indicates that there was no separate "test set" of patient data used for evaluating the performance of the Synergy Focus in a clinical or AI context, as its performance is considered equivalent due to identical or functionally equivalent hardware and software to already cleared devices.

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

Since no clinical or AI-specific test set was used requiring ground truth establishment by experts, this information is not applicable to this 510(k) submission.

4. Adjudication Method for the Test Set

As no test set involving human interpretation requiring adjudication was used, this information is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The submission explicitly states that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness," and the device is a diagnostic electromyograph, not an AI-assisted diagnostic tool in the sense of image interpretation. Therefore, there is no AI assistance improvement effect size to report.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on an algorithm's performance without human-in-the-loop was not done. The Synergy Focus is a hardware and software system for acquiring and displaying physiological signals, not a standalone algorithm providing diagnostic outputs. The software component, categorized as "MODERATE level of concern," underwent rigorous verification and validation during development, as noted in the "Software testing" section, but this is distinct from an AI algorithm's standalone performance study.

7. Type of Ground Truth Used

Given the nature of the device and the submission's focus on substantial equivalence through technical characteristics and non-clinical testing, there was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of evaluating the diagnostic accuracy of a new algorithm or clinical performance. The ground truth (or reference standard) in this submission relates to:

• Engineering specifications and standards: The device's performance was compared against the technical specifications of the predicate devices and national/international standards (e.g., IEC 60601-2-40 for safety and performance of electromyographs).
• Predicate device characteristics: The primary "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the Nicolet EDX with Viking and Synergy software systems.

8. Sample Size for the Training Set

Since there is no mention of an AI algorithm or machine learning component in this submission that would require training data, information regarding the sample size for a training set is not applicable. The software validation focused on standard software development lifecycle testing (verification and validation of pre-determined specifications), not on training a model.

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

As there was no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

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