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This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.

The device is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold).

Examples of surgical applications which may require mechanomyographic (MMG) monitoring:

• Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologics.
• Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminectomies, laminotomies, facetectomies, foraminotomies.
• Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis.

The Neuralytix iD3 System is a multichannel device for locating, mapping and assessing the status of motor nerves during surgical procedures. Neuralytix alerts the user of recorded mechanical activity (termed mechanomyography, or MMG) from muscles innervated by affected nerves, which may originate from operator applied electrical stimulus. The device will assist with nerve identification and assessment by alerting the surgeon when monitored nerves are activated. The device will also assist with tracking the status of monitored nerves throughout the course of surgical intervention. Neuralytix is especially useful in helping assess a patient's neurophysiologic status by measuring and identifying nerve response thresholds, or the minimum amount of electrical current (mA) necessary to elicit an MMG response. Neuralytix enables intuitive controls for measuring, recording and comparing nerve response thresholds throughout a surgical procedure to provide insights to the user as to how the conduction and neural transmission ability of a nerve may change throughout surgery.

The provided FDA 510(k) clearance letter and summary for the Neuralytix iD3 System offer details on device acceptance criteria and performance testing. However, it's important to note that the document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering and performance characteristics, rather than a clinical multi-reader multi-case (MRMC) study or standalone AI performance evaluation as might be found for imaging AI devices.

Based on the provided text, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence to a predicate device (Sentio MMG Gen 2) and conformity to recognized consensus standards. The performance testing outlined is primarily engineering and bench-top validation rather than clinical studies with human readers or AI-only performance.

Here's a breakdown of the information as requested, with details extracted from the provided text and limitations noted where information is not present:

Acceptance Criteria and Device Performance for Neuralytix iD3 System

The acceptance criteria for the Neuralytix iD3 System are primarily defined by its ability to demonstrate substantial equivalence to its predicate device (Sentio MMG Gen 2) in terms of technological characteristics and performance, as well as adherence to relevant consensus standards for medical devices. The "study" proving acceptance is a compendium of non-clinical, bench-top performance tests, biocompatibility evaluations, and material characterizations.

The core function being tested for performance is "MMG-detection performance."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Performance Tests: The document frequently uses the phrase "All samples passed the acceptance criteria," but it does not specify numerical sample sizes for most of the individual performance (bench-top) tests. For the "Comparative Performance Evaluation" of MMG-detection, it states "a statistically significant sample" was captured, but the exact number is not provided.
• Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether a clinical dataset was retrospective or prospective. Given the nature of the tests (bench-top, signal simulation), it's not applicable in the same way as for clinical image-based AI studies. The "clinically relevant MMG signal simulation" implies simulated data rather than data from actual human patients.

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

• Not Applicable. The "Comparative Performance Evaluation" uses "clinically relevant MMG signal simulation" and compares the subject device's output to that of the predicate device, not to human expert interpretation of MMG signals. Therefore, there is no mention of experts establishing a ground truth for a test set in the traditional sense of clinical labeling or diagnostic interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication method (e.g., 2+1, 3+1) is mentioned, as the primary performance evaluation is a direct comparison of the subject device's signal detection performance against a predicate device using simulated waveforms, not human interpretation.

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

• No. An MRMC comparative effectiveness study was not conducted based on the provided summary. The comparison is between the subject device's MMG detection performance and the predicate device using simulated waveforms, not with human readers.
• Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, implicitly. The "Comparative Performance Evaluation" section describes testing the Neuralytix iD3 System's "MMG-detection performance" by subjecting it (and the predicate device) to "MMG-positive and MMG-negative waveforms." This evaluates the device's technical ability to detect MMG signals in a controlled environment, which can be considered a form of standalone technical performance (algorithm/system only). However, this is distinct from testing a standalone AI algorithm's diagnostic performance on a clinical dataset.

7. The Type of Ground Truth Used

• The ground truth for the "Comparative Performance Evaluation" was based on "clinically relevant MMG signal simulation" (i.e., known MMG-positive and MMG-negative waveforms) which were then fed into both the subject and predicate devices. This is a technical ground truth based on simulated signals, not a clinical ground truth from patient outcomes, pathology, or expert consensus on patient data.

8. The Sample Size for the Training Set

• The document does not mention a training set or any deep learning/machine learning model training process. The device's function as described (measuring mechanomyographic signals and electrical stimulation thresholds) sounds like a traditional signal processing system rather than a machine learning-based AI system that would require a distinct training set.

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

• Not applicable, as no training set or machine learning model for which a ground truth would need to be established is mentioned.

Summary Limitations:

The provided FDA summary primarily addresses the substantial equivalence of the Neuralytix iD3 System to a predicate device via detailed technical and engineering comparisons and bench-top performance testing. It does not describe clinical trials, MRMC studies, or specific AI model validation processes that involve human interpretation or large, diverse clinical datasets. The "Comparative Performance Evaluation" is a technical test against simulated signals, not an evaluation of diagnostic accuracy in a clinical setting by human readers or an AI.

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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 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.

The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

This document is an FDA 510(k) clearance letter for a medical device called the "ALARA BMA Neuro Access Kit." This type of document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting detailed study results for a new AI/ML-driven diagnostic device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML diagnostic. The "Performance Testing" section lists various engineering and material tests (e.g., torque, pull, strength, sterilization, biocompatibility) relevant to the physical components of the device, not performance metrics for an AI algorithm.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device description and performance testing sections indicate a physical medical instrument (needles for biopsy, aspiration, and a neuromonitoring platform for "proximity feedback" during pedicle preparation). There is no mention of an AI or machine learning algorithm. The "proximity feedback" is likely an electrical or mechanical system, not an AI interpreting images or data.
• Focus on Substantial Equivalence: A 510(k) clearance is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparing design, materials, intended use, and non-clinical performance (like the engineering tests listed). It does not typically involve the rigorous clinical efficacy studies or AI performance validation described in your prompt.
• Lack of Diagnostic Claims: The device is for "aspiration of bone marrow or autologous blood," "pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback," and "harvesting core biopsy samples." These are procedural/interventional uses, not diagnostic uses that would involve interpreting data (image, signal, etc.) with an AI.

In summary, as the provided document pertains to a physical medical device and not an AI/ML-driven diagnostic, the questions about acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to the content provided.

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The iovera® System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera System is not indicated for treatment of central nervous system tissue.

When stimulation compatible components are used, the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

The iovera System is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, NoO) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera8 System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The device is comprised of four main components:

• A reusable Handpiece .
• A Charging Dock ●
• An assortment of single-patient-use Smart Tips ●
• A Cartridge containing nitrous oxide ●

The provided text describes the iovera® System, a cryogenic surgical device cleared by the FDA (K243677). The document focuses on demonstrating substantial equivalence to predicate devices (K220656 and K211334) for a new Smart Tip configuration (STT21180STIM) that also facilitates nerve location.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on adherence to recognized standards and satisfactory completion of design verification testing. Specific quantitative acceptance criteria for each test (e.g., specific thresholds for biocompatibility, precise tolerances for mechanical tests) are not explicitly detailed in this summary, but the general outcome of "meets all ISO10993-1 and USP acceptance criteria" or "complied with standards" is stated.

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

The document summarizes design verification testing rather than a clinical study with a "test set" of patient data. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this regulatory summary. The testing focuses on engineering verification (e.g., number of units tested for mechanical properties, number of samples for biocompatibility, etc.), not patient data.

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

Again, this pertains to a clinical study with patient data and does not apply to the design verification testing described. The "ground truth" for the engineering tests would be the compliance with recognized standards and specified performance parameters.

4. Adjudication Method for the Test Set:

Not applicable, as this is design verification testing rather than a clinical study requiring consensus from experts on case interpretation.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, not on evaluating human reader performance with or without AI assistance. The device in question is a physical cryogenic surgical device, not an AI diagnostic tool that assists human readers with interpretations.

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

Not applicable. The iovera® System is a physical medical device, not an algorithm. Performance is assessed through engineering tests of the device itself. While it facilitates nerve location, its primary function is direct tissue destruction via freezing, with a human operator always in the loop.

7. The Type of Ground Truth Used:

For the design verification testing, the "ground truth" used is:

• Compliance with recognized international and national standards (e.g., ISO 10993-1, IEC 60601-1, IEC 62366-1, ISO 11135, ASTM standards).
• Pre-defined product specifications and design input requirements for physical, electrical, mechanical, software, and biological properties.
• Laboratory test results (e.g., chemical analysis for extractables, temperature measurements for cooling performance, force measurements for bond strength).

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set of data.

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

Not applicable, as there is no training set for this type of medical device submission.

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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 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.

The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.

The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

The provided text describes the regulatory clearance of the ALARA BMA Neuro Access Kit, focusing on its substantial equivalence to predicate devices based on design, materials, and non-clinical testing. However, it does not include acceptance criteria, reported device performance, or details of a study that proves the device meets specific performance criteria.

Therefore, I cannot populate the table or answer questions 2 through 9 based on the provided document. The document primarily focuses on regulatory approval based on comparison to existing legally marketed devices, rather than a detailed performance study against predefined acceptance criteria.

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TELIGEN Navigation Ready Instruments:

The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion.

TELIGEN Clear and TELIGEN Access Probe, when used with UNAS Navigation Rings, can be precalibrated with:

• · the VELYS Spine System using the VELYS Spine Instrument Arrays,
• · the Brainlab Navigation System using the UNAS Arrays.

TELIGEN Access Probe in conjunction with UNAS can also be manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.

The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.

Discectomy Navigation Ready Instruments:

The Discectorny Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectomy or bony resection. These are indicated for use in surgical spinal procedures, in which:

• · the use of stereotactic surgery may be appropriate, and
  · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy using a navigation system and associated navigation arrays.

These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready Instruments can be pre-calibrated with the VELYS Spine System (only for TELIGEN Graft Delivery Cannula and the curettes) as well as the Brainlab Navigation System.Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be:

· pre-calibrated with the VELYS Spine System using VELYS Spine System Instrument Arrays,

• · pre-calibrated and/or manually calibrated with the Brainlab Navigation System,
  where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

TELIGEN Navigation Ready Instruments

TELIGEN Navigation Ready Instruments are part of TELIGEN Kits.

The TELIGEN Kits are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation.

The TELIGEN Kits include a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments. Additionally, the TELIGEN Procedure Kit Pro includes an Access Probe.

TELIGEN Access Probe and TELIGEN Clear are part of the DePuy Synthes Navigation Ready Instruments Portfolio and are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Discectomy Navigation Ready Instruments

The Discectomy Navigation Ready Instruments are reusable instruments used for disc space preparation, including discectomy or bony resection. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS) and associated navigation arrays. For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set

The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with the VELYS Spine System as well as Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays,
• . VELYS Spine/Brainlab compatible Navigation Rings and
• Medtronic compatible Navigation Ring ST. ●

The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments.

When the VELYS Spine/Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument:

• . VELYS Spine System Instrument Array can be attached and the instrument can be used with the VELYS Spine System as pre-calibrated instrument, or
• . UNAS Navigation Array can be attached and the instrument can be used with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument.

When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation Navigation System.

This submission pertains to the TELIGEN System Navigation Ready Instruments, which include the TELIGEN Access Probe, TELIGEN Clear, TELIGEN Graft Delivery Cannula, and associated curettes, along with the Universal Navigation Adaptor Set (UNAS). The primary purpose of this 510(k) submission is to expand the compatibility of these instruments with the VELYS Spine System.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a tabular format. However, it states the following performance aspects were evaluated:

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

The document does not specify the exact sample size or number of "test cases" for the evaluations (Accuracy Verification, CAD Model Evaluation, Simulated Use Evaluation). It refers to "engineering analysis" and "simulated use evaluation" which typically involve a set of defined tests rather than a statistical sample size of patient data.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given the nature of the device (surgical instruments with navigation capabilities), the evaluations would likely be laboratory-based and simulated environments.

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

The document does not mention the use of experts to establish ground truth for the test set. The evaluations described (engineering analysis, meeting manufacturer's requirements, CAD model, simulated use) suggest a focus on design validation and performance specifications rather than clinical evaluation with expert-defined ground truth on patient data.

4. Adjudication method for the test set:

The document does not describe any adjudication method. This type of evaluation, for surgical instruments, typically relies on direct measurement and adherence to specifications rather than subjective expert assessment requiring adjudication.

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

No mention of an MRMC comparative effectiveness study, or any studies involving human readers, is found in the provided text. The device is a set of surgical instruments, not an AI diagnostic tool that would typically involve human reader studies.

6. Standalone (algorithm only without human-in-the-loop performance) Study:

Not applicable. The device is a set of physical surgical instruments with navigation capabilities, not a standalone algorithm. Its performance is intrinsically tied to its use by a surgeon within a navigation system.

7. Type of Ground Truth Used:

Based on the evaluation types:

• For Accuracy Verification and Navigation Systems Instrument Accuracy Requirements, the ground truth would be the established engineering specifications, dimensional tolerances, and the accuracy claims/requirements published by the navigation system manufacturers (e.g., VELYS Spine System, Brainlab, Medtronic StealthStation®).
• For CAD Model Evaluation, the ground truth would be the design specifications and theoretical performance derived from the CAD models.
• For Simulated Use Evaluation, the ground truth would be the defined objective criteria for successful surgical simulation (e.g., precise instrument placement, proper interaction with simulated anatomy).

8. Sample Size for the Training Set:

Not applicable. The device is a set of physical surgical instruments, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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

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

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

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

The subject device records the following modalities:

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

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

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

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

What the document provides:

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

What the document lacks significantly for your request:

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

Why this information is missing:

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

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

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The 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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