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The ALM Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative neuromonitoring by recording the EMG activity of the laryngeal musculature when connected to an appropriate neuromonitoring device.

This device must be used in connection with the C2 Xplore® or any approved IEC 60601-1, compatible EMG monitoring system with 42802 DIN compatible connectors.

The ALM Tube is an endotracheal intubation tube which combines the function of airway ventilation and intraoperative neuromonitoring purposes regarding recording of electrophysiological signals. It combines the recording of EMG signals from the vocal cords to monitor the recurrent laryngeal nerve or the vagal nerve function during surgical procedures. The product is used intraoperatively and is connected to an appropriate neuromonitoring device for signal recording outside of the sterile field via a connection cable. The connection cable is not part of the delivered package.

This FDA 510(k) clearance letter details a medical device, the ALM Tube, but it does not describe an AI/ML powered device or a study comparing its performance against acceptance criteria in the manner requested.

The questions in your prompt are geared towards evaluating AI/ML device performance and related studies (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment). The ALM Tube is an endotracheal intubation tube with integrated electrodes for neuromonitoring, which is a hardware device.

Therefore, many of the requested details cannot be extracted from this document because they are not applicable to the type of device described.

Here's an attempt to answer the questions based on the provided text, highlighting where information is absent or irrelevant:

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

The document describes the device's adherence to various international standards and internal requirements rather than specific, quantifiable acceptance criteria with corresponding performance metrics like sensitivity/specificity for an AI model.

The study that proves the device meets the acceptance criteria is a compilation of various engineering, bench, biocompatibility, sterilization, and packaging tests, as well as a human factors evaluation. This is stated in the "Summary of Performance Testing" section and the "Conclusion," which claims: "Verification and validation activities and human factors engineering testing were undertaken in order to establish the performance and safety characteristics of the ALM Tube. The results of these activities demonstrate that the ALM Tube is as safe, effective and perform as well as the predicate device, despite the differences in technology between the subject and predicate device."

Missing/Not Applicable Information based on the provided document:

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

   • N/A. The document states: "No additional clinical testing was performed for the ALM tube. Therefore, this section does not apply." The performance evaluation relies on bench testing, biocompatibility, sterilization, and packaging validation. For the human factors testing, the 'sample size' is described as "representative US citizens" for a knowledge test, but no specific number is provided.

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)

   • N/A. No "ground truth" establishment by medical experts is described, as this is not an AI/ML diagnostic or prognostic device requiring expert consensus on clinical cases.

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

   • N/A. No expert adjudication of clinical cases 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

   • N/A. The device is a physical endotracheal tube with neuromonitoring capabilities, not an AI assistance tool for human readers.

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

   • N/A. This is not an algorithm-only device. It requires connection to an "appropriate neuromonitoring device" and is used in a clinical setting by medical professionals.

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

   • N/A. For this type of physical medical device, "ground truth" typically refers to established engineering specifications, material properties, and standardized test methodologies. The document indicates adherence to relevant ISO and IEC standards for these aspects.

8. The sample size for the training set

   • N/A. This device does not use a training set as it is not an AI/ML product.

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

   • N/A. This device does not use a training set.

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The product is used for intraoperative monitoring and testing during surgical procedures
· to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation

The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations:

• · Measurement:
• o Auditory evoked potentials (AEP)
• o Electroencephalography (EEG)
• o Electrocorticography (ECoG)
• o Electromyography (EMG)
• o Somatosensory evoked potentials (SSEP)
• o Motor evoked potentials (MEP)
• o Train of Four (TOF)
• · Stimulation:
• o Transcranial electrical stimulation (TES)
• o Direct cortical and subcortical stimulation (DCS)
• o Direct nerve stimulation (DNS)
• o Transcutaneous intraoperative nerve stimulation (TINS)
• o Direct muscle stimulation (DMS)

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodal intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.

The ISIS IOM Systems support the following measurement modalities:

• -Auditory Evoked Potentials
• -Transcranial and cortical Motor Evoked Potentials
• Somatosensory Evoked Potentials -
• Free-running and triggered Electromyography -
• Electroencephalography -
• Train of Four -

The provided document is a 510(k) summary for the ISIS Headboxes and ISIS Neurostimulator, which are intraoperative neuromonitoring systems. It focuses on demonstrating substantial equivalence to a predicate device (K212166) rather than establishing novel acceptance criteria and proving performance against them in a clinical study.

The document states that no additional clinical testing was performed for the subject devices. Instead, the submission relies on bench testing against established standards and internal requirements to demonstrate safety, effectiveness, and performance that is "as well as or better than" the predicate device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a de novo AI/ML device (which often involves clinical performance metrics like sensitivity, specificity, etc.) are not directly applicable or available in this document.

Here's an attempt to extract the relevant information based on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to a predicate device through bench testing rather than a de novo AI/ML device with pre-defined performance metrics, the acceptance criteria are primarily related to adherence to international standards and internal requirements for electrical safety, EMC, and software validation.

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

• Sample Size: Not applicable in the traditional sense of a clinical test set with patient data. The testing was primarily bench and software validation. The "sample size" would refer to the number of units tested, which is not specified, but implied to be sufficient for type testing.
• Data Provenance: The data refers to the results of internal bench tests and software validation activities, conducted by the manufacturer (inomed Medizintechnik GmbH) in Germany. It is entirely retrospective in the sense that it's performed on a developed product to meet predefined standards.

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 because no clinical test set with expert-established ground truth was used. The ground truth for functional verification would be the expected output or behavior according to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical test set requiring expert adjudication.

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. The device is a neuromonitoring system, not an AI-assisted diagnostic or interpretive tool that would inherently involve "human readers" in that sense. The submission explicitly states: "No additional clinical testing was performed".

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

• The document implies that the "software validation" and "bench testing" constitutes a standalone performance evaluation of the device's functional integrity as an algorithm/system. The software (NeuroExplorer) and hardware components were tested to ensure they meet their predetermined specifications and comply with relevant standards independently of human interpretation of clinical outcomes. However, this is not an "AI algorithm only" type of standalone performance, but rather functional performance of medical device software/hardware.

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

• For the bench and software testing, the "ground truth" would be established by the engineering specifications, international performance standards (e.g., IEC 60601 series), and documented functional requirements of the device. This is a technical (rather than clinical/biological) ground truth.

8. The sample size for the training set

• This device is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. Therefore, this question is not applicable. The software development follows a traditional software lifecycle process, not a machine learning training paradigm.

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

• Not applicable, as there is no mention of an AI/ML training set.

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The C2 Xplore is designed for use in the operating room to measure and display the neurophysiological signals. The system supports the application of Electromyography (EMG) for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The system is not intended for monitoring life-sustaining functions.

The C2 Xplore is an electromyography (EMG) monitor for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The C2 Xplore assists the surgeon in nerve identification, helping to locate and identify nerves at risk in the surgical field. The device records the EMG activity from the innervated nerves and provides visual and audible feedback for the surgeon, helping to preserve the nerve structures throughout the procedure. The device is equipped with 8 differential amplifier channels and with two independent stimulators. The C2 Xplore is operated via mechanical turning knobs and a touchscreen on the front. The audio feedback is generated by an integrated loudspeaker. The nerve monitoring provides information about the amplitude and latency of the EMG responses.

The provided text describes the C2 Xplore device, an electromyography (EMG) monitor for intraoperative neuromonitoring of the peripheral nervous system. It outlines various aspects of the device's design, intended use, and comparisons to a predicate device (C2 NerveMonitor System) and a reference device (Medtronic Xomed, Inc Nerve Integrity Monitor 3.0).

However, the document does not contain specific acceptance criteria in numerical or quantitative terms for the device's diagnostic or clinical performance (e.g., sensitivity, specificity, accuracy for nerve identification). Instead, it discusses compliance with general safety, performance, and software standards.

Therefore, I cannot create a table of "acceptance criteria and reported device performance" as defined by specific clinical metrics. The document focuses on regulatory compliance and substantial equivalence rather than a detailed performance study with clinical outcomes.

Based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

As no specific quantitative clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided in the document for the device's primary function of nerve identification, a direct table of "acceptance criteria and reported device performance" in that sense cannot be created.

However, the document does detail compliance with various technical standards and internal requirements, which serve as acceptance criteria for different aspects of the device:

• Compliance with applicable guidance documents and standards (FDA guidance on premarket submissions for software, off-the-shelf software, software validation, cybersecurity).
• Rigorous development process, including software verification and validation. | "Test results demonstrate that the C2 Xplore software complies with its predetermined specifications, the applicable guidance documents and standards."
  "The software was designed and developed according to a rigorous development process, including software verification and validation."
  "The product successfully underwent the bench testing of the requirements at these levels as part of the verification and validation process." |
  | Electrical Safety | - Compliance with IEC 60601-1:2005+A1:2012 (or 2012 reprint).
• Compliance with IEC 60601-1-6:2010+AMD1:2013 (Usability).
• Compliance with IEC 60601-2-40:2016 (Electromyographs and evoked response equipment).
• Class I protection, 4000 V.
• Device type BF (Body Floating) for patient leads. | "The C2 Xplore was tested according to the following standards: [listed standards]. Test results demonstrate that the products comply with the applicable standards."
  "Class I protection 4000 V"
  "Device type BF (Body Floating)" |
  | Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2:2014. | "The essential performance and safety of the C2 Xplore was tested according to the following standards: [listed standard]. Test results demonstrate that the products comply with the applicable standards." |
  | Bench Performance Testing | - Compliance with internal requirements for general device, functional, external interface, system accessory, and C2 Xplore software/firmware/OS requirements. | "The essential performance and safety of C2 Xplore was tested for performance in accordance with internal requirements."
  "The product successfully underwent the bench testing of the requirements at these levels as part of the verification and validation process." |
  | Human Factors | - Demonstration of mitigation of potential use errors.
• Safety of user interface design. | "Moreover, the testing of the influence of human factors on the device was conducted to demonstrate mitigation of potential use errors and safety of the user interface design." |
  | Overall Safety and Effectiveness | - As safe, as effective, and performs as well as, or better than, the legally marketed predicate device. | "The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate."
  "The results of these activities demonstrate that the devices are as safe, effective and perform as well as or better than the predicate device." |

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

• Test Set Sample Size: Not applicable. The document states, "No additional clinical testing was performed for the C2 Xplore. Therefore, this section does not apply." The performance testing described is primarily technical bench testing and compliance with standards, not a clinical study on patient data.
• Data Provenance: Not applicable for a clinical test set. The data provenance would be from internal lab testing and compliance assessments, not patient data from a specific geographical region or retrospective/prospective study design.

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

Not applicable. As no clinical testing with patient data or medical imaging was performed, there was no need for experts to establish ground truth in a clinical context.

4. Adjudication method for the test set:

Not applicable. No clinical test set requiring expert adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

No. The document explicitly states, "No additional clinical testing was performed for the C2 Xplore." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported.

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

Not applicable in the context of diagnostic AI. The C2 Xplore is a hardware device with integrated software for neuromonitoring, which inherently involves a human (surgeon) interpreting the visual and audible feedback. It is not an "algorithm only" device designed to operate independently of human intervention for its intended use of nerve identification during surgery. Its standalone performance is described through its technical specifications and compliance with safety and performance standards.

7. The type of ground truth used:

For the technical performance (EMG recording, stimulation, electrical safety, EMC, software functionality), the ground truth is established by engineering specifications, international technical standards, and validated test procedures. For example, the accuracy of voltage/current delivery, noise levels, and frequency response would be verified against known, precisely controlled inputs and expected outputs according to design specifications and relevant standards.

8. The sample size for the training set:

Not applicable. The C2 Xplore is described as an electromyography monitor and stimulator, not an AI/ML device that requires a distinct "training set" of data for learning a clinical pattern. Its software compliance involves verification and validation against predetermined specifications and guidance documents, which is a different paradigm from data-driven AI model training.

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

Not applicable, as no AI model training set is mentioned for the device.

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The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.

The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument. The stimulation function of the Mapping Suction Probe is used for monopolar stimulation during intraoperative surgical interventions and is connected to electrical stimulators of neuromonitoring devices outside the sterile field via an appropriate integrated connection cable. To ensure a correct monopolar stimulation, a counter electrode is also included in the sterile package which must be placed at the resection marqin. The suction function of the Mapping Suction Probe is used for aspiration during tumor resection and is connected to suction devices via a tube, which is not part of the delivered package.

The provided text is an FDA 510(k) summary for a medical device called the "Mapping Suction Probe." It contains information about the device's indications for use, comparison to a predicate device, and performance data related to biocompatibility and bench testing.

However, the request asks for specific details about acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).

The provided document does NOT contain any information about AI, software, or clinical studies that would align with the detailed acceptance criteria and study design requested (e.g., MRMC studies, expert ground truth, training/test set sample sizes for AI models).

The document explicitly states:

• "The Mapping Suction Probe does not contain any kind of software, Software: and therefore, this section does not apply to it." (Page 8)
• "Clinical testing was not performed for the Mapping Suction Probe." (Page 9)

Therefore, based on the provided text, it's impossible to answer the majority of the questions related to AI/SaMD acceptance criteria and performance studies. The information available pertains to the physical device's safety and performance characteristics (biocompatibility, electrical safety, mechanical tests, etc.) compared to a predicate device, which is typical for a 510(k) submission for a non-software, non-AI hardware device.

Given the limitations of the provided text, I must state that the requested information (related to AI/SaMD acceptance criteria and studies) is not present in the document.

I will indicate which sections cannot be answered based on the input.

Acceptance Criteria and Device Performance (Based on available data, primarily biocompatibility and bench testing for a hardware device)

Since this is a physical device without AI/software components, the "acceptance criteria" are related to its physical and functional safety and equivalence to the predicate, rather than AI performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

| Category | Acceptance Criteria (based on standards/tests) | Reported Device Performance |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity: No reduction of cell proliferation/viability. | Cytotoxicity (Device): No reduction of cell proliferation/viability observed; dehydrogenase activity 101% at 100% extract conc.; no inhibition/lysis microscopically. Conclusion: Non-cytotoxic. |
| | Sensitization: 0% sensitization rate. | Sensitization (Device): 0% sensitization rate after application. Conclusion: No sensitizing properties. |
| | Irritation / Intracutaneous Reactivity: Primary irritation index of 0. | Irritation / Intracutaneous Reactivity (Device): Primary irritation index of 0 for polar and non-polar extracts. Conclusion: Not irritant. |
| | Acute Systemic Toxicity: No compound-related mortalities or signs of toxicity. | Acute Systemic Toxicity (Device): No compound-related mortalities or signs of toxicity within 72 hours post-dose. Conclusion: No acute systemic toxic characteristics. |
| | Material Mediated Pyrogenicity: Temperature increase for each rabbit not > 0.50°C. | Material Mediated Pyrogenicity (Device): Temperature increase for each rabbit not > 0.50°C. Conclusion: Materials considered non-pyrogenic. |
| | Hemolysis: Haemolytic indices

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ISIS Headbox 5042xx products:

The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues.

The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).

The products are not intended for monitoring life-sustaining functions.

ISIS Neurostimulator 504180:

The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:

• Transcranial electrical stimulation (TES)
• Direct cortical stimulation (DCS)
• Direct nerve stimulation (DNS)
• Transcutaneous electrical nerve stimulation (TNS)
• Direct muscle stimulation (DMS)

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.

The ISIS IOM Systems support the following measurement modalities:

• Auditory Evoked Potentials
• Transcranial and cortical Motor Evoked Potentials
• Somatosensory Evoked Potentials
• Freerunning and triggered Electromyography
• Electroencephalography
• Train of Four

The provided text describes a 510(k) summary for the Inomed Medizintechnik GmbH's "ISIS Headboxes and ISIS Neurostimulator" (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (Cadwell Industries Inc./Cascade Intraoperative Monitor K162199).

Crucially, this document does not contain acceptance criteria or a study proving device performance in the way a clinical study for a new diagnostic or AI-driven imaging device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering performance testing (bench testing, electrical safety, EMC, software validation) and a comparison of technical specifications and intended uses.

Therefore, I cannot populate all sections of your requested table and provide information on aspects like sample size for test sets, ground truth establishment, expert adjudication, or MRMC studies, as these types of studies were explicitly not performed for this 510(k) submission. The document states: "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply."

Here's the information that can be extracted relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on engineering performance and comparison to a predicate, the "acceptance criteria" are primarily adherence to relevant electrical safety and electromagnetic compatibility (EMC) standards, and meeting predetermined specifications during bench testing and software validation. The "reported device performance" is the successful compliance with these standards and specifications.

• Adherence to FDA guidance: "The content of premarket submissions for software contained in medical devices, May 11, 2005"
• Adherence to FDA guidance: "Off-the-shelf software use in medical devices, Sep 27, 2019"
• Adherence to FDA guidance: "General principles of software validation: Final guidance for industry and FDA staff, Jan 02, 2002"
• Adherence to FDA guidance: "Content of premarket submissions for management of cybersecurity in medical devices. Oct 02, 2014"
• Adherence to IEC 62304:2006, Medical device software - Software life cycle processes | "Test results demonstrate that the inomed NeuroExplorer Software complies with its predetermined specifications, the applicable guidance documents, and standards." | The software ("NeuroExplorer") is categorized as a "MODERATE level of concern software." |
  | Electrical Safety | - Compliance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint).
• Compliance with IEC 80601-2-26:2019 (electroencephalographs).
• Compliance with IEC 60601-2-40:2016 (electromyographs and evoked response equipment). | "Test results demonstrate that the products comply with the applicable standards." | The document compares specific technical aspects like A/D resolution, hardware bandpass, sampling frequency, notch filter, CMRR, and amplifier noise to the predicate device, indicating equivalent or compliant performance with relevant standards. |
  | Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2:2014. | "Test results demonstrate that the products comply with the applicable standards." | |
  | Bench/Performance Testing | - Fulfillment of requirements formulated at multiple levels: electrical medical systems, system carrier, amplifier (Headboxes) and stimulator (Neurostimulator) modules, operating software (NeuroExplorer) incl. firmware, and accessories.
• Assessment of human factors influence on safety. | "The products successfully underwent the bench testing to confirm the fulfillment of the requirements at these levels as part of the verification and validation process."
  "The testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary." | This testing is internal to the manufacturer's verification and validation process. The specific quantitative "requirements" are not detailed in this public summary but are typically part of internal design specifications. |
  | Biocompatibility | N/A | N/A | The devices do not have patient contact materials, therefore testing was not applicable. |

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

This information is not applicable and not provided in the document. As stated, "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply." The testing described are engineering verification and validation tests, not clinical studies with patients or data sets in the typical sense for AI/diagnostic devices.

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

This information is not applicable. The performance testing was based on engineering standards and internal requirements, not expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.

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. This device is an intraoperative neuromonitoring system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.

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

This information is not applicable. This device is an intraoperative neuromonitoring system, not primarily an algorithm performing a standalone diagnostic task. Its function is to measure and display electrophysiological signals and provide stimulation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth or reference for device performance was established through engineering standards, technical specifications, and internal functional requirements. For example, electrical outputs meet specified ranges, and input signals are recorded with specified fidelity according to IEC standards. This is not clinical ground truth (e.g., pathology report, expert diagnosis).

8. The Sample Size for the Training Set

This information is not applicable. The document does not describe the use of an AI algorithm that requires a training set in the context of a machine learning model for diagnosis or interpretation. The software validation refers to standard software development practices, not AI model training.

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

This information is not applicable, as there was no mention of a training set for an AI algorithm.

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The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal nerve roots. The C2 NerveMonitor device with the interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device.

Indications for C2 NerveMonitor System Monitoring Procedures include: Extracranial, Intratemporal, Extratemporal, Neck Dissections, and Upper and Lower Extremities.

Indications for C2 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments. Pedicle Screw Procedures, Fusion Cages, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures.

The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.

The C2 NerveMonitor System performs intraoperative neurophysiologic monitoring (IONM) for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device. The system is not intended for monitoring life preserving functions.

The subject device stimulates for evoked responses, records, measures, and provides visual and auditory outputs for the physiological responses received from the patient. The response signals may be stimulated evoked responses or spontaneous electrophysiological action potential signals. The subject software calculates the signal amplitude and latency. The subject device provides a visual display and auditory tones corresponding with the actions performed or signals received. The waveforms are stored in the device internal memory. The user may review the signals after surgery in printed or electronically exported report formats.

The C2 NerveMonitor System consists of 4 and 8 Channel C2 NerveMonitor consoles and an optional iPad application as subject of this submission. The system also includes stimulation probe and recording electrodes, laser printer, adapter box, cables, WiFi router, sterile iPad cover, mute sensor, footswitch, and keyboard accessories that are not subject to this submission.

The C2 NerveMonitor consoles consist of software, hardware, and electrical components. The software has been updated and is subject to this submission. The software updates introduce optional device connectivity and the signal peak detection algorithm. The connectivity allows for Hospital Information System (HIS) Ethernet network interface, and wireless connection via iPad application. The signal peak detection algorithm supports channel select, synthetic sound, and quantitative measurements displayed during signal receipt features.

The document indicates that modifications to the C2 NerveMonitor System primarily involve software updates, specifically introducing optional device connectivity and a signal peak detection algorithm. The provided text primarily describes the non-clinical verification and validation performed on these software changes.

1. Table of acceptance criteria and the reported device performance

Statement on meeting criteria: The document explicitly states: "The verification and validation testing results demonstrate all requirements were fulfilled. The software testing was performed with the latest software version 3.0, and on production equivalent versions of the C2 NerveMonitor. The testing was relevant and the results met the pre-defined acceptance criteria. The testing results confirm the changes meet the pre-defined specifications and do not raise different questions of safety and effectiveness for the subject devices."

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

The document does not explicitly mention "sample size" in terms of number of patient cases or data points for a specific test set. The testing described is software verification and validation.

• Test Set Size: Not explicitly stated in terms of patient data. The testing was performed on "production equivalent versions of the C2 NerveMonitor" with the latest software version 3.0.
• Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical, related to software functionality and system performance.

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

This information is not applicable and not provided. The testing described is non-clinical software verification and validation, not clinical performance evaluation requiring expert ground truth in a diagnostic sense.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical software testing, not a clinical study requiring adjudication of patient outcomes or assessments.

5. Multi reader multi case (MRMC) comparative effectiveness study:

No, an MRMC comparative effectiveness study was not done. The document states: "Clinical testing was deemed not required to support the safety and effectiveness of the subject device for the intended use."

6. Standalone (i.e. algorithm only without human-in-the-loop performance) study:

Yes, the testing performed was primarily a standalone evaluation of the modified software and the overall system's functionality. The focus was on verifying that the software updates (connectivity and peak detection algorithm) and overall system performance met predefined specifications in a non-clinical setting.

7. Type of ground truth used:

For the software verification and validation, the 'ground truth' was based on the predefined specifications and requirements of the software and system design. The testing ensured that the implemented changes behaved as expected according to these engineering and functional specifications.

8. Sample size for the training set:

Not applicable. This document describes software updates to an existing medical device and the associated verification and validation. It does not refer to a machine learning algorithm that would require a "training set" for model development. The "signal peak detection algorithm" mentioned is part of the software logic, not a machine learning model.

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

Not applicable, as there was no training set for a machine learning model.

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The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device

Indications for C2 NerveMonitor System Monitoring Procedures include:

Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.

Indications for C2 NerveMonitor System monitoring of Spinal procedures include:

Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Procedures and Thoracic Surgical Procedures.

The system is not intended for monitoring life preserving functions.

The system may not be used for diagnosing brain death.

The C2 NerveMonitor System is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying stimulus for evoked responses. The EMG activity monitoring console uses both video and audio output.

Responses monitored with the device may originate from operator applied stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery.

The provided text describes the C2 NerveMonitor System, an intraoperative neurophysiological monitor. However, it does not contain specific acceptance criteria, a study that proves the device meets acceptance criteria, or details regarding the methodologies listed in your request (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth type, training set size, and ground truth establishment for the training set).

Instead, the document is a 510(k) Summary, which is a premarket notification to the FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

The "NONCLINICAL AND CLINICAL TEST" section states:
"Preclinical testing verified the design of this device and that all specified requirements were fulfilled. The C2 NerveMonitor and all corresponding accessories are similar in their risks and benefits, as well as their manner of performance, to the predicate devices listed."

This is a general statement of verification and claims similarity to predicate devices, but it does not present the detailed information you requested about acceptance criteria and performance studies.

Therefore, I cannot populate the table or answer the specific questions because the information is not present in the provided document.

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The Inomed Adhesive Laryngeal Electrodes are intended to be used as a disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

The Inomed Adhesive Laryngeal Electrodes are single used electrodes constructed from an medical grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene: and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor

The provided document describes a 510(k) premarket notification for the Inomed Adhesive Laryngeal Electrodes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance metrics in the way a clinical trial would for a novel device.

Here's an analysis of the information provided based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Study Details for Inomed Adhesive Laryngeal Electrodes

No explicit "acceptance criteria" table with reported device performance is provided in the document. The submission is a 510(k) summary, which demonstrates substantial equivalence by comparing the new device's technical characteristics and intended use to a legally marketed predicate device. The "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate and introduces no new questions of safety or effectiveness.

The document states: "After analyzing performance and safety testing, it is the conclusion of Inomed that the inomed adhesive laryngeal electrodes are as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness." This implies that the device successfully passed relevant tests, but the specific quantitative criteria and results are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, a formal table of quantitative acceptance criteria and reported numerical performance is not provided in this 510(k) summary for the Inomed Adhesive Laryngeal Electrodes. Instead, the comparison table focuses on qualitative and design characteristics between the new device and the predicate devices. The "performance" assessment is summarized as the device being "as safe and effective as the predicate devices."

The comparison table provided (page 2) lists characteristics to demonstrate equivalence, but not quantitative performance criteria:

The "agreement criteria" for this type of submission are that the new device performs equivalently to the predicate devices in terms of these characteristics.

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

The document mentions "performance and safety testing" and adherence to "appropriate electrical testing standard and biocompatibility standards," but does not specify a patient-based "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The tests performed are primarily non-clinical (electrical and biocompatibility) to support substantial equivalence, not a clinical effectiveness trial.

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

This information is not applicable/not provided as there is no described clinical study involving expert interpretation or "ground truth" establishment in the context of device performance in a diagnostic or interpretive sense. The testing focuses on product safety and functional equivalence to the predicate, likely through laboratory and engineering tests.

4. Adjudication method for the test set:

This is not applicable/not provided for the same reasons as point 3.

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 is not applicable/not provided. The device is a laryngeal electrode for EMG monitoring, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

This is not applicable/not provided. The device is an electrode, not an algorithm. Its function is to facilitate EMG monitoring.

7. The type of ground truth used:

Given the nature of the device and the submission, the "ground truth" for the non-clinical tests would be established by engineering specifications, international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety), and comparison to the predicate device's documented characteristics. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this summary.

8. The sample size for the training set:

This is not applicable/not provided. There is no "training set" in the context of this device, as it is a medical device (electrode) and not a machine learning model.

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

This is not applicable/not provided for the same reason as point 8.

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The ISIS MER System / Elekta MER System is intended to be used during neurosurgery to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.

During neurosurgical interventions the ISIS MER System / Elekta MER System is used for optimal extra cellular recording and deep brain stimulation. The system operates the integrated neurostimulator that delivers impulses similar to the effect of an implanted electrode. Recording and stimulation of up to five channels are possible simultaneously. A sixth channel may be used for EMG recording for optimal patient surveillance.

The provided text is a 510(k) summary for the Inomed GmbH ISIS MER System / Elekta MER System. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics, safety, and effectiveness to its predicate.

Based on the provided text, there is no information available regarding acceptance criteria, a specific study proving the device meets those criteria, or details regarding the methodologies listed in your request (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details, etc.).

Here's why and what information is present:

• Type of Submission: This is a Traditional 510(k). The primary goal of a 510(k) is to establish substantial equivalence to a predicate device, not necessarily to set new performance acceptance criteria or conduct extensive clinical effectiveness studies in the same way a PMA (Premarket Approval) would require.
• Focus of the Document: The document explicitly states: "The functionality for the ISIS MER System / Elekta MER System are equivalent to its predicate devices... in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in this 510k submission." This indicates a focus on comparing technical specifications and intended use rather than presenting novel performance studies against defined acceptance criteria.
• Information Absent:
  • No table of acceptance criteria or reported device performance for newly established metrics.
  • No mention of a dedicated "study" to prove specific performance targets.
  • No details on sample sizes for test sets or training sets.
  • No information about data provenance, expert panels, adjudication methods, or ground truth establishment.
  • No discussion of MRMC studies or standalone AI algorithm performance, as this device (depth electrode recording system) is not an AI-driven diagnostic tool in the sense of image analysis.

Conclusion:

The provided 510(k) summary does not contain the information required to answer your questions about acceptance criteria and a specific study proving the device meets those criteria. The submission aims to demonstrate substantial equivalence to predicate devices (Axon Guideline System 3000A and Dantec / Medtronic Keypoint / Leadpoint system) based on similar technological characteristics, safety, and effectiveness, rather than establishing new performance benchmarks with detailed study results. The device itself is a depth electrode system for neurosurgery, not an AI-based diagnostic tool, which typically would involve the extensive validation studies you are asking about.

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