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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 Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.

Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.

Bioscope Neuromonitor Device is a nerve locator and monitor. The device has 3 infrastructure;

• Electronic
• Mechanic
• Software

These infrastructures are integrated with each other and work with the principle of stimulating current at 0.01-10 mA levels, conceiving EMG signals from related muscles groups. Collected signals are interpreted by the device and auditory and visual notifications will be given.

The device basically consists of stimulation and EMG subsystems. Both stimulation and EMG lines can send and collect signals from 2 channels. Depending on the operation, an EMG Endotracheal Tube or needle electrode is inserted into the muscles innervated by the relevant nerves for EMG reading. The electrode parts of the EMG tube are placed in contact with the muscles attached to the vocal cords. Needle electrodes are also inserted into the relevant muscle. Appropriate current is sent with the stimulation probe. The electrical changes in the muscles in the region and are transmitted to the device as a signal. The device gives audible and visual warnings.

Channels works on the principle of potentially stimulating the critical region through monopolar or bipolar probe connection and completing the circuit, allowing the device to make a nerve-tissue separation audibly and visually. It allows the detection of nerves such as the recurrent laryngeal nerve, which are connected to the vocal cords. The doctor brings the probe into contact with the area of potential nerve risk. The current sent to the patient through the probe causes a change in the electrical activity of the nerves and the muscles to which the nerves are connected, and this change can be detected by the device. Based on the collected data, the device gives clear audible alerts for nerve-tissue separation. The EMG signal collected from the patient is displayed as a both voltage value and latency times on the output. These values can be recorded and the interface can be used to select specific details, such as the right and left sides of the vagus, and recurrent laryngeal nerves.

The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.
Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative performance acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) for the Bioscope Neuromonitor Device. Instead, the acceptance criteria are implied through adherence to recognized medical device standards and the demonstration of "similar technical features" and "safety and effectiveness" compared to predicate and reference devices.

The reported device performance is primarily described as compliance with various international standards for medical electrical equipment, software life cycle processes, and specific requirements for nerve and muscle stimulators. The conclusion from nonclinical tests is that the device is "as safe, as effective, and perform as well as the legally marketed predicate device."

Table of Acceptance Criteria (Implied) and Reported Device Performance:

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

The provided document describes non-clinical performance testing. This type of testing typically involves laboratory-based evaluations, bench testing, and simulations to demonstrate compliance with standards and functional requirements. It does not mention clinical studies involving patient data or human subjects. Therefore, there is no information provided regarding a "test set" in the context of patient data (e.g., sample size, country of origin, retrospective/prospective).

The "test set" in this context refers to the device itself and its components undergoing various engineering, electrical, and software validation tests.

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)

As the testing described is non-clinical performance testing (bench testing, standard compliance), the concept of "ground truth" established by experts for a test set of patient cases is not applicable here. The "ground truth" in this context would be the specifications and expected performance values defined by the relevant standards and the device design. The "experts" would be the engineers, quality assurance personnel, and regulatory specialists conducting and reviewing these tests. No specific number or qualifications of such experts are mentioned beyond the general reference to "Test results demonstrate that the Bioscope Neuromonitor Device complies with the applicable standards."

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

Again, since this is non-clinical performance testing and not a clinical study involving human assessment of cases, the concept of an "adjudication method" for a test set is not applicable. Test results are typically evaluated against established technical specifications and standard requirements, not through expert consensus on case interpretations.

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 mentioned or performed. This submission describes a conventional medical device that provides intra-operative monitoring and stimulation. It is not an AI-assisted diagnostic or interpretative device that would typically involve human readers or AI assistance for image interpretation.

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

The Bioscope Neuromonitor Device is an active medical device that provides real-time information to a surgeon during surgery. It is not an "algorithm only" device or an AI system that operates without human-in-the-loop performance. Its function is to assist the surgeon by providing auditory and visual notifications based on EMG signals. Therefore, the concept of a "standalone (algorithm only)" performance study without human interaction is not applicable to this device.

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

For the non-clinical performance testing, the "ground truth" used is the defined technical specifications, functional requirements, and the pass/fail criteria established by the international standards listed (e.g., IEC 60601-1, IEC 62304, etc.). For instance, for accuracy of current output, the ground truth would be the known, calibrated output of measurement equipment used to verify the device's output.

8. The sample size for the training set

No information about a "training set" is provided. As this is a conventional neuro-monitoring device based on electrical stimulation and EMG signal detection, it does not appear to involve machine learning or AI models that would require a training set in the typical sense. The software validation is mentioned in the context of IEC 62304, which focuses on software life cycle processes and validation, not on training an AI model.

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

Since no training set is mentioned or applicable to this type of device, there is no information on how its ground truth would have been established.

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The disposable laryngeal electrodes are intended to be used as a disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

The Disposable 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 is a 510(k) summary for a medical device called "Disposable Laryngeal Electrodes." It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study conducted, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes for the individual tests (adhesive property, electrode impedance, security, sterility, biocompatibility tests). It only states that testing was performed.

The data provenance is from non-clinical laboratory testing conducted by Suzhou Haishen United Medical Device Associates Co., Ltd. The document does not specify the country of origin of the data beyond the manufacturer's location (Suzhou, Jiangsu Province, China). The studies are by nature prospective as they are conducted specifically for the purpose of demonstrating device 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 to this type of device and study. The testing performed is bench testing (e.g., electrical, mechanical, biological) against established engineering and biological standards, not clinical performance requiring expert interpretation of diagnostic outputs or ground truth establishment by clinical experts.

4. Adjudication method for the test set

Not applicable. As the studies are bench tests against objective criteria and standards, there is no need for expert adjudication methods like 2+1 or 3+1. The results are quantitative measurements or pass/fail determinations based on predefined criteria.

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 a passive electrode for EMG monitoring during surgery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this section is not applicable.

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

Not applicable. This device is an electrode, which is a hardware component. There is no algorithm or AI component to be evaluated in a standalone manner.

7. The type of ground truth used

The "ground truth" for the non-clinical tests are established international standards and internal requirements for medical devices. Specifically:

• Performance (electrical/physical): Internal requirements, and likely general engineering principles for electrodes.
• Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, and FDA guidance on ISO 10993-1.
• Sterilization: ISO 11135:2014 and ISO 10993-7.
• Electrical safety: IEC 60601-1.

8. The sample size for the training set

Not applicable. This device is a hardware component and does not involve AI or machine learning models that require a training set.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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The EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.

The provided text describes a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM Standard Reinforced EMG Endotracheal Tube and NIM CONTACT Reinforced EMG Endotracheal Tube. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a de novo device meets specific performance criteria through extensive clinical studies.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that one would find for a novel device or an AI/ML-based device seeking de novo authorization or PMA. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: This document focuses on demonstrating equivalence to predicate devices, not on meeting predefined performance metrics for a novel technology.
• Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or type of ground truth for a test set. These elements are typically found in studies designed to validate the performance of a diagnostic or therapeutic device against a gold standard, especially for AI/ML products.
• Sample size for the training set or how ground truth for the training set was established: This information is pertinent to machine learning models, which are not the subject of this 510(k) submission.

What the document does describe regarding "performance data" is limited to nonclinical testing for usability and labeling design validation to support substantial equivalence.

Here's an analysis of the "Performance Data" section based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The document does not present quantitative acceptance criteria for the device's technical or diagnostic performance in the way one would see for a novel medical device like an AI algorithm. Instead, the "acceptance" is tied to proving substantial equivalence to predicate devices. The performance data presented relates to usability and labeling effectiveness, which are indirectly linked to safety and effectiveness.

• Usability Goal: "The Anesthesiologist/Nurse Anesthetist shall be able to intubate the patient and maintain the airway without introducing any unrealized use errors or critical tasks."
• Critical Tasks: "Confirm the Critical tasks were completed without any unacceptable Use Error that may have resulted in unmitigated potential hazards."
• Risk Mitigations: "To show the risk mitigations were effective in regard to labeling and training."
• Labeling Design Validation User Need: "The product labeling was to be understandable and provide needed information for proper safe and effective use of the device."

Reported Performance:
"The results of these validations with the modified proposed labeling demonstrated that the usability goal was achieved, all critical tasks were completed without introducing any additional unmitigated hazards, the user need and risk control measures were met and the training mitigations proposed were effective."

2. Sample Sizes and Data Provenance:

The document mentions "Summative Usability Validation" and "Labeling Design Validation" but does not specify the sample size (e.g., number of users, number of simulated scenarios) used for these nonclinical tests.
The data provenance is implied to be from internal testing conducted by the manufacturer, Medtronic Xomed, Inc., as part of their 510(k) submission process. It is not retrospective or prospective clinical data in the typical sense. The country of origin of the data is not explicitly stated but is implied to be in the US, given the FDA submission.

3. Number of Experts and Qualifications:

The document refers to "Anesthesiologist/Nurse Anesthetist" as the target users for the usability testing. However, it does not specify the number of experts used in the usability or labeling validation studies, nor their specific qualifications (e.g., years of experience). These individuals would have served as the "test subjects" or "evaluators" for the usability study, not necessarily as "experts establishing ground truth" in a diagnostic context.

4. Adjudication Method:

The document does not mention any adjudication method. This is not relevant for the type of usability and labeling validation studies described. Adjudication is typically used in studies where multiple human readers or algorithms produce interpretations that need to be reconciled to establish a ground truth (e.g., for diagnostic accuracy studies).

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

No MRMC study was conducted or reported. The device is not an AI/ML diagnostic aid that assists human readers. It is an endotracheal tube with EMG monitoring capabilities. The "performance data" is purely for usability and labeling effectiveness, not comparative diagnostic accuracy for human readers with or without an AI.

6. Standalone Performance (Algorithm Only):

This section is not applicable. The device is a physical medical device (an endotracheal tube), not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm's output.

7. Type of Ground Truth Used:

For the usability and labeling studies, the "ground truth" was essentially defined by the successful completion of critical tasks without unacceptable use errors and the understandability of the labeling, as determined by the study design and its evaluators. This is not "expert consensus," "pathology," or "outcomes data" in the clinical diagnostic sense. It's about demonstrating safe and effective interaction with the device.

8. Sample Size for the Training Set:

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable for the same reason as above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, with performance data limited to nonclinical usability and labeling validation. It does not provide the details typically found in studies for novel diagnostic or AI/ML devices that aim to prove specific performance metrics against a clinical ground truth.

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The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.

The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.

The provided text describes the 510(k) summary for the EARP Nerve Cuff Electrode, a surgical nerve stimulator/locator. It does not pertain to an AI/ML medical device, but rather a physical medical device. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI/ML device's performance are not present in this document.

However, I can extract the information related to the acceptance criteria and the study that proves the physical device meets these criteria, based on the provided FDA 510(k) summary.

Here's an attempt to answer as much as possible given the limitations of the provided text, recognizing that it's for a traditional medical device, not an AI/ML one:

Acceptance Criteria and Device Performance for the EARP Nerve Cuff Electrode

Since this is a physical medical device submission, the "acceptance criteria" are based on non-clinical performance and biocompatibility testing, demonstrating the device's safety and effectiveness in its intended use, and its substantial equivalence to predicate devices. The "study" refers to the non-clinical testing performed.

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

The document lists "Summary of Non-Clinical Testing" which serves as the "study" proving the device meets the acceptance criteria. The acceptance criteria are implied by the "Conclusion" column (e.g., "no evidence of causing cell lysis or toxicity" for cytotoxicity), and the "Pass/Fail" column indicates whether the device met these criteria.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of units, animals, or test replicates) for each test. It mentions "mice" and "guinea pig" for specific biocompatibility tests, implying the use of animal models according to the ISO standards.
• Data Provenance: The provenance is through laboratory testing conducted on the device components or extracts. The document does not specify the country of origin where the tests were performed, nor whether the data involved retrospective or prospective collection of patient data, as this is laboratory testing of a physical device.

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

This concept is not applicable to the type of device described. "Ground truth" established by experts is typically relevant for interpretative devices like AI/ML products where human experts provide labels or diagnoses for comparison. For a physical medical device like an electrode, the "ground truth" is established by adherence to recognized performance standards (e.g., ISO, IEC, USP) and validated laboratory test methodologies. The "experts" would be the qualified personnel performing and interpreting these specific laboratory tests.

4. Adjudication method for the test set

This concept is not applicable as there is no "adjudication" of human interpretations for this type of device. The results are based on objective measurements from standardized laboratory tests.

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 concept is not applicable as this is not an AI/ML device, and no human reader study was performed.

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

This concept is not applicable as this is not an AI/ML device and does not involve an algorithm. The device's "standalone" performance is assessed through its physical characteristics and electrical/biocompatibility safety in laboratory settings.

7. The type of ground truth used

The "ground truth" for this physical device is established by:

• Established Performance Standards: Adherence to ISO, IEC, and USP standards for biocompatibility, electrical safety, and mechanical integrity.
• Objective Measurements: Laboratory measurements of physical, chemical, and electrical properties compared against pre-defined specifications derived from these standards or engineering requirements.

8. The sample size for the training set

This concept is not applicable as this is not an AI/ML device that requires a training set.

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

This concept is not applicable as this is not an AI/ML device that requires a training set.

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The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.

The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.

The provided text is a 510(k) summary for a medical device (NIM™ 35cm long Surgeon Control Probe). It describes the device, its intended use, and why it is considered substantially equivalent to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device, as implied by the detailed questions (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance, etc.).

The "Performance Testing Discussion" section (Page 6) details typical engineering verification and validation tests for a physical medical device, such as electromechanical performance, sterilization validation, electrical safety, biocompatibility, stability, packaging performance, and usability testing. These are standard tests for hardware devices, not for assessing the performance of an AI model's diagnostic or predictive capabilities.

Therefore, I cannot provide a table of acceptance criteria for AI performance or answer most of the specific questions about the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document.

Here's what I can infer from the document regarding the performance testing that was conducted:

• Acceptance Criteria & Reported Performance: The document states that "Design performance testing was completed to ensure the functionality and intended use of the NIM™ 35cm long surgeon control probe was met in accordance with external standards, and device specifications via pre-defined acceptance criteria." It also notes that "This performance testing was used to support substantial equivalence, proving the subject device is as safe and effective as its predicate device." While specific numerical performance values against acceptance criteria are not provided, the conclusion is that the tests yielded "passing results" and demonstrated the device is "safe and effective."

  The performance tests listed are:

  • Electromechanical, dimensional, and visual design performance
  • Sterilization validation to ISO 11135:2014
  • Electrical safety & EMC testing to IEC 60601
  • Biocompatibility testing and risk analysis to ISO 10993-1:2018
  • Stability testing of proposed shelf life
  • Packaging performance of environmental conditioning to ISTA 3A and distribution simulation to ASTM D4169
  • Usability testing to IEC 62366-1:2015

• Sample Size for Test Set and Data Provenance: The document states "Bench engineering test samples were subjected to simulated real-life conditions during functional testing to establish baseline data and accelerated aging data." It does not specify the exact number of samples. Data provenance is not applicable in the sense of patient data; it's product performance testing.

• Number of Experts Used to Establish Ground Truth and Qualifications: This information is not relevant to the type of device and testing described. The "ground truth" for this device is established by engineering specifications, international standards, and physical measurements/tests.

• Adjudication Method: Not applicable for engineering performance testing of a physical device.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images/data. This device is a surgical nerve stimulating probe, not an image analysis or diagnostic AI.

• Standalone (algorithm only) Performance: Not applicable. There is no algorithm in the described function that operates standalone for diagnostic or predictive purposes. The "algorithm" here would literally be the electrical stimulation function itself, which is a physical property.

• Type of Ground Truth Used: For this device, the ground truth is based on engineering specifications, applicable international standards (e.g., ISO, IEC, ASTM), and established physical principles.

• Sample Size for Training Set: Not applicable. This document describes the validation of a physical medical device, not the training of an AI model.

• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is for a physical medical device (a surgical nerve stimulating probe) seeking 510(k) clearance based on substantial equivalence to a predicate device, supported by standard engineering performance and usability testing. It does not involve AI or an algorithm in the sense that would require the detailed AI-specific study information requested in your prompt.

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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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The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

The NIMTM surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.

The provided document is a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM™ Surgeon Control Probes. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing. However, it does not contain information about an AI/ML-based medical device study.

The document details safety and effectiveness testing for a physical medical device (nerve stimulator probes), not a software algorithm that performs diagnostic or prognostic tasks. Therefore, many of the requested elements (like "AI vs without AI assistance," "ground truth," "training set," "multi reader multi case study," etc.) are not applicable to the information contained in this FDA clearance letter.

Based on the provided text, here's what can be extracted and what information is missing/not applicable:

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

The document states that "Design performance testing was completed to ensure the functionality and intended use of the NIM™ Surgeon Control Probes was met in accordance with external standards, and device specifications via pre-defined acceptance criteria." It then lists the types of tests performed. It does not present a specific table with quantitative acceptance criteria and corresponding performance results. It generally states that the tests yielded "passing results."

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

• Sample Size for Test Set: The document mentions "Bench engineering test samples" but does not specify the sample size for any of the performance tests.
• Data Provenance: Not applicable in the context of this device's testing. The testing appears to be primarily lab-based engineering performance testing of physical prototypes, not data collection from patients or medical images. It's not a retrospective or prospective study on patient data.

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

• Not applicable. This device is hardware for stimulating nerves, not an AI system requiring expert consensus for a "ground truth" diagnosis or image interpretation. The "ground truth" for this device's performance would be engineering specifications and standards.

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

• Not applicable. This study is not evaluating expert interpretation of medical data. Performance is evaluated against objective engineering standards and specifications.

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, this study was not conducted. The device is a surgical tool, not an AI software designed to assist human readers (e.g., radiologists) in interpreting cases.

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

• Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its design and manufacturing.

7. The type of ground truth used:

• The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., IEC, ISO, ASTM) and the manufacturer's own pre-defined device specifications. It's not clinical diagnosis or outcomes data in the context of an AI study.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not applicable. Because no AI/ML model training set is involved, this question is irrelevant to the provided document.

In summary: The provided FDA clearance letter is for a traditional hardware medical device (nerve stimulator probes) and describes its performance testing against engineering and safety standards to demonstrate substantial equivalence to predicate devices. It does not contain information related to the development or validation of an AI/ML-based medical device.

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