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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 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 vertebrac 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, when used with UNAS, can be precalibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System, where other navgation systems require manual calibration and 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.

The TELIGEN Procedure Kit Pro is a sterile, single use kit intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation.

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

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

The TELIGEN Access Probe is intended to stimulate peripheral motor nerves, including spinal nerve roots, for location and identification during surgery. It contains an insulated probe compatible with the SENTIO MMG System. The SENTIO MMG sensors serve to measure a mechanomyographic (MMG) response and the SENTIO MMG System's detection of this response alerts the surgeon of nerve location in the proximity of the TELIGEN Access Probe's distal tip.

The provided FDA 510(k) summary describes the TELIGEN System's "Peripheral Motor Nerve Stimulation Indications." This section details the acceptance criteria and the studies performed to demonstrate equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test listed (Electrical Safety, Functional Performance, Sterility). It refers to "All samples and evaluations passed acceptance criteria." The data provenance (country of origin, retrospective or prospective) is not specified, but these are typically in-house engineering and lab tests.

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

This information is not applicable. The device is a surgical instrument for nerve stimulation, and the performance evaluations are based on engineering and laboratory testing against established standards (e.g., IEC 60601-1, ISO 11135) and internal design specifications, not on clinical interpretation or expert consensus on a "ground truth" derived from patient data.

4. Adjudication Method for the Test Set

This is not applicable. The evaluations are objective measurements and assessments against predefined technical standards and specifications, not subjective interpretations requiring adjudication.

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

There was no MRMC comparative effectiveness study, as this device is a surgical instrument and not an AI-powered diagnostic imaging tool or a system involving human "readers."

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

This is not applicable. The device is a physical surgical instrument for nerve stimulation and does not have an "algorithm-only" performance component as understood in the context of AI/software as a medical device. Its performance is related to its physical and electrical characteristics.

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

The "ground truth" for the performance claims of the TELIGEN Access Probe as a nerve stimulator is based on established engineering and electrical standards, and the known physiological response of peripheral motor nerves to electrical stimulation. For biocompatibility, it's based on ISO 10993-1.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical instrument, not an algorithm, and therefore does not have a "training set" in the context of machine learning.

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

This is not applicable as there is no training set for this device.

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The ATEC IOM Accessory Instruments 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 ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user.

The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating.

The provided document is a 510(k) summary for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing. It does not describe an acceptance criteria and study proving device meets acceptance criteria in the context of clinical performance or accuracy of an AI/ML device.

Therefore, I cannot extract the specifically requested information regarding acceptance criteria and study details as they pertain to such a device type because this information is not present in the provided document.

The document discusses:

• Manufacturing and material equivalence: The new dilators are made of conductive silver ink, aluminum alloy, and dielectric coating and are compared to existing predicate devices.
• Performance testing (non-clinical): This includes electrical safety testing (IEC 60601-1), functional performance testing (insulation effectiveness and electrical resistance), and reprocessing validation. All samples passed acceptance criteria for these tests.
• Biocompatibility testing: Evaluated per ISO 10993-1 for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.

None of these tests involve "device performance" in terms of clinical accuracy, AI/ML output, or human-in-the-loop effectiveness.

However, I can extract the information that is present about the non-clinical performance testing:

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

2. Sample size used for the test set and the data provenance: Not applicable. The tests mentioned are laboratory-based electrical, functional, and reprocessing tests, not clinical studies with patients or data sets with provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and sterilization tests, not expert-adjudicated clinical assessments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical or image-based adjudication, not engineering 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: Not applicable. This device is an accessory instrument, not an AI/ML diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory instrument, not an AI/ML algorithm.

7. The type of ground truth used: Not applicable in the context of clinical accuracy or AI performance. For the engineering tests, "ground truth" would be the specifications and requirements of the applicable standards (e.g., IEC 60601-1, AAMI TIR30, ANSI/AAMI/ISO 17665-1).

8. The sample size for the training set: Not applicable. This device is not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML product.

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The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.

Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.

Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.

The Neurosign® V4 Intraoperative Nerve Monitor (IONM) is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery. The subject device differs from its primary predicate due to the introduction of improved Pre-amplifier and Stimulator pod cables, as well the addition of an 8-channel Pre-amplifier variant.

Using needle or surface electrodes connected to the Pre-amplifier, the nerve monitor detects electromyographic (EMG) signals within muscles caused by the contraction of the muscle due to mechanical manipulation or electrical stimulation of the nerve controlling it. The Neurosign® V4 then amplifies the EMG data into an audible signal and displays the data as a waveform on the active monitoring screen.

The Neurosign® V4 Intraoperative Nerve Monitor is used for patient treatment by prescription only under the supervision of a licensed physician.

The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories.

The provided document is a 510(k) Premarket Notification from the FDA for the Neurosign® V4 Intraoperative Nerve Monitor. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically a study that establishes performance against discrete clinical acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain a study with acceptance criteria and reported device performance in the typical sense of a clinical trial for a novel device. Instead, the "acceptance criteria" are compliance with various recognized standards and the "study" is non-clinical bench testing to demonstrate that modifications to an existing predicate device do not alter its safety or effectiveness.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes used for the Test Set and Data Provenance

This submission is based on non-clinical bench testing and does not involve human subjects as a "test set" in the sense of a clinical study.

• Electrical Safety, EMC, Alarm Systems, Biocompatibility: "A sample Neurosign® V4 (4-Channel and 8-Channel Variants)" or "A sample Neurosign® V4 (4-Channel)" or "Samples of these materials" were tested. The exact number of units/samples is not specified beyond "a sample" or "samples."
• Human Factors Testing: Not specified, but "Usability testing was performed to analyze the user experience of the 8-Channel Neurosign® V4." This typically involves a small group of representative users, but the size is not disclosed.
• Data Provenance: All testing appears to be retrospective relative to the design changes, commissioned by Magstim Company Ltd. and conducted by either Magstim or independent test laboratories (Element Materials Technology, Eurofins Hursley). The country of origin for the tests is not explicitly stated for all labs, but Magstim is a UK company.

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

This type of submission does not involve "ground truth" established by clinical experts in the context of diagnostic accuracy or treatment effectiveness. The "ground truth" here is compliance with recognized engineering and safety standards, as verified by independent test laboratories and Magstim's internal testing. The qualifications would be expertise in those specific standards and testing protocols, which are inherent to the testing bodies but not explicitly detailed for individual experts in this document.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of clinical outcomes. The "adjudication" is essentially the determination of compliance with the specified standards by the testing bodies.

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

No. This document does not describe a MRMC comparative effectiveness study. The device is an intraoperative nerve monitor, and the study focuses on its safety and performance based on engineering and safety standards, and its substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a way. The testing described (electrical safety, EMC, alarm systems, biocompatibility, and software V&V) assesses the device's technical performance and safety characteristics in isolation, or as an integrated system, without necessarily involving a human-in-the-loop performance assessment of its diagnostic or treatment guidance capability in a clinical setting beyond usability testing for user experience. The "performance" mentioned for cables is also standalone bench testing.

7. Type of Ground Truth Used

The ground truth used in this context is:

• Compliance with recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series for biocompatibility, AAMI/ANSI HE75, IEC 62366-1 for human factors).
• Performance specifications (e.g., isolation parameters, EMC performance, software functions) as tested against predefined engineering requirements.
• Usability metrics defined in the human factors engineering report.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. It is a hardware medical device with embedded software. The software underwent verification and validation, but this refers to traditional software testing, not AI model training.

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

Not applicable, as there is no AI/ML training set in this context.

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PediGuard and PediGuard Cannulated systems:

The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard system is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

PediGuard Threaded System:

The PediGuard Threaded System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebration. PediGuard Threaded System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

DSG Zavation screw system:

The Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

The DSG Connect technology is a pedicle screw system used for bone drilling procedure during open or minimally invasive spinal fusion. The devices provide visual and audible alerts to a surgeon to indicate a change in electrical conductivity at the tip of the probe that may indicate contact of the tip with soft tissues. The DSG Connect Technology provides the user with an optional visual graphical presentation of the electrical conductivity information communicated by the DSG Connect devices to a tablet, with the App providing a visual representation of the audio signal emitted by the device handle. The App allows for display and recording of the signal, including graphing of changes in the audio signal over time.

The DSG Connect technology is incorporated in to the handles of the Cannulated PediGuard Threaded system, and DSG Zavation screw system.

The provided text describes the 510(k) submission for the "DSG Connect Technology" and details its performance evaluation. However, it does not contain a table of acceptance criteria or specific detailed reported device performance against those criteria in a quantitative manner. Instead, it lists various tests performed to demonstrate safety and effectiveness for a device that provides visual and audible alerts based on impedance changes during pedicle screw insertion, and optionally displays this data on a tablet.

Therefore, for the aspects that require specific quantitative acceptance criteria or detailed study results (points 1, 5), the information is not present in the provided document. For other points, I will extract what is available.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

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

Information Not Provided: The document does not present a table with quantitative acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity) and corresponding numerical performance results. Instead, it lists categories of tests performed and their general purpose ("Verify that X is Y" or "Ensure Z").

Based on the "Performance Data" section (Page 6-7), here's a summary of the types of tests mentioned, which implies the acceptance criteria would be for the device to meet these verified specifications:

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

• Sample Size: The document does not specify a numerical sample size for the "test set" in the context of clinical performance. The "System Evaluation" mentions "surgeon in a pig lab," which indicates animal testing, but not a human clinical test set.
• Data Provenance: The "pig lab" study details are not provided, so country of origin or retrospective/prospective nature is unknown. Given it's a 510(k) for a device already on the market (with previous versions), the focus seems to be on demonstrating equivalence through non-clinical performance and a limited system validation. This is typical for a 510(k) for a modified device.

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)

Information Not Provided: The text mentions "System design validation by surgeon in a pig lab" but does not specify the number of surgeons or their qualifications for establishing any "ground truth" for a test set. This device relies on real-time impedance feedback, not pre-existing data (like images) that would require expert annotation for ground truth.

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

Information Not Provided: No adjudication method is mentioned, which aligns with the absence of specific clinical "test set" ground truth establishment by multiple experts.

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

Information Not Provided: The device, "DSG Connect Technology," is a nerve stimulator/locator that provides real-time feedback (visual and audible alerts, and optional graphical display on a tablet) during pedicle screw insertion. It is not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study for human reader performance improvement. Its function is to provide direct intraoperative guidance, not to assist in interpreting complex medical images.

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

Information Provided (Implicitly): The device functions primarily as a standalone measurement tool, providing real-time electrical conductivity information. The "Output signal evaluation" test ("Verify that the output signal of the modified device... is equivalent to the predicate device for similar conductivity levels") suggests a standalone evaluation of its core electrical performance. The wireless communication and app display are enhancements for presenting this standalone data. The device's "alerts" are an automated output of its algorithm.

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

For a device that measures impedance to indicate potential contact with soft tissues or cortex perforation during surgery, the "ground truth" would generally be:

• Physical measurement/calibration: For tests like "Pulse output" and "Output signal evaluation," the ground truth is often established by known electrical properties of test media or by comparison to a validated predicate device.
• Direct observation during animal/cadaveric studies: For tests like "System Evaluation (surgeon in a pig lab)," the "ground truth" for successful or problematic screw placement would be based on direct anatomical observation, post-procedure imaging, or direct nerve stimulation responses.
• Design specifications/standards: For safety, mechanical, and software verification tests, the "ground truth" is adherence to predefined engineering specifications, regulatory standards (like IEC 60601-1/-2), and functional requirements.

The document does not explicitly state the ground truth establishment method for each test, but inferring from the test descriptions, it would be a combination of these.

8. The sample size for the training set

Information Not Applicable/Provided: This device does not appear to be based on a machine learning model that would require a "training set" in the typical sense of AI/ML software (i.e., learning from vast amounts of data). It is a device that provides feedback based on direct electrical impedance measurements and established physiological responses to electrical stimulation.

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

Information Not Applicable/Provided: As this is not an AI/ML device requiring a training set, this question is not relevant.

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The ATEC IOM Accessory Instruments 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 ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user.

The provided document is a 510(k) Premarket Notification for the ATEC IOM Accessory Instruments. This document focuses on demonstrating substantial equivalence to predicate devices based on design, technology, and performance data, not clinical performance data. Therefore, the information typically required to describe acceptance criteria and a study proving a device meets these criteria in the context of clinical performance (e.g., sample size for test sets, expert adjudication, MRMC studies, ground truth establishment) is largely absent.

However, the document does contain information about performance testing for non-clinical aspects. Below is an interpretation of the available information in the context of your request.

Please note: The document explicitly states "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means that the study you are asking about, which would typically involve human subject data and clinical endpoints, was not conducted or submitted for this 510(k) clearance. The performance data presented refers to engineering and safety testing.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Information Regarding a Clinical Study (Not Applicable as per the Document)

As explicitly stated in the document, no clinical performance data was provided or relied upon for this 510(k) clearance. Therefore, the following points cannot be addressed from the given text as they pertain to clinical studies.

2. Sample size used for the test set and the data provenance: Not applicable for a clinical study. For the non-clinical tests, the sample sizes are not specified beyond "All samples passed," meaning at least one sample was tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical ground truth. For non-clinical tests, the ground truth would be defined by the testing standards (e.g., IEC 60601-1, ISO 10993-1).
8. The sample size for the training set: Not applicable for a clinical study. This device does not use a "training set" in the sense of machine learning.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Clearance Basis:

The ATEC IOM Accessory Instruments are surgical tools designed to assist in locating nerves during spinal surgical procedures. Their clearance (K191723) was based on substantial equivalence to existing legally marketed predicate devices, specifically K182617 (ATEC IOM Accessory Instruments) and K132138 (Rhythmlink Disposable Concentric Stimulating Probe).

The substantial equivalence was demonstrated through:

• Comparison of indications for use, design, function, and technology.
• Compliance with relevant electrical safety standards (IEC 60601-1).
• Reliability testing.
• Functional performance testing (insulation effectiveness, electrical resistance).
• Biocompatibility testing per ISO 10993-1, largely leveraging existing data and material characterization.

The crucial point is that this clearance did not involve a clinical performance study with human subjects, as the FDA determined it was not necessary to establish substantial equivalence for this type of device.

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

The ALARA Neuro Access Kit with Access Needle, Sheath and Extension Handle is a single use: sterile stimulating electrode is manufactured with the following materials: 316 and LVM Stainless Steel, IXEF 1022/9008 and Lustram ABS. The disposable ALARA Neuro Access Kit is an Access Needle insulated with a sheath (see figure 1). The sheath is full length except for the distal tip (either a diamond or bevel tip) which provides tissue stimulation. The needle utilizes an extension handle as an accessory (see figure 2) to provide the surgeon stability in placement of the access needle and by providing support by allowing for more working space during a surgical procedure. The device is kitted with a set of individually packaged and (single use) disposable Alligator Clips (Rhythmlink International Alligator Clip RLSP487) see figure 3.

The provided document is a 510(k) summary for the ALARA Neuro Access Kit, which is a medical device for pedicle pilot hole preparation, locating, and identifying spinal roots/nerves by providing proximity feedback. The summary details performance testing conducted to demonstrate the device meets acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of samples used for each bench test. It uses phrases like "the samples were able to functionally perform the test" or "the sample(s) to be in compliance," which implies that a sample size was used but not quantified.
The testing was retrospective bench testing performed on the device itself, simulating use cases in laboratory conditions. There is no information provided about the data provenance in terms of country of origin, as it is device bench testing rather than clinical data.

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

This section is not applicable as the studies described are bench tests to assess physical and electrical properties of the device, not clinical performance studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication. The "ground truth" for these tests comes from engineering specifications and objective measurements (e.g., torque, force, electrical properties).

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

No, an MRMC comparative effectiveness study was not performed. The provided document details bench testing for physical and electrical performance, not a clinical study involving human readers or AI assistance.

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

Not applicable. The ALARA Neuro Access Kit is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests is based on engineering specifications and established safety standards. For example, the torque required to cause failure must exceed 25 in-lbs, and the force required to cause failure must exceed 60 lbf. Electrical safety is verified against IEC 60601-1 Edition 3.1. These are objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product, so there is no "training set." The testing performed is to validate the physical device's performance against pre-defined specifications.

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

Not applicable. As there is no training set for an AI/ML product, there is no ground truth to establish for such a set.

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The ATEC IOM Accessory Instruments 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 ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws).

The document provided is a 510(k) premarket notification for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, functionality, and performance testing. However, it explicitly states:

"Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This means the submission does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human-in-the-loop studies involving AI. The acceptance criteria and performance data provided are related to functional, electrical safety, biocompatibility, and reprocessing aspects of the surgical instruments themselves, not their performance in a clinical diagnostic or prognostic context with AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/clinical performance study.

The document covers the following types of acceptance criteria and proven performance for the ATEC IOM Accessory Instruments (which are surgical tools, not an AI diagnostic device):

1. Table of Acceptance Criteria and Reported Device Performance (Summary of Engineering/Safety Tests):

The document does NOT provide information for the following points, as they are not relevant to a device submission for surgical instruments focused on substantial equivalence based on material and functional safety rather than AI performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System.

The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems.

The BE-ST Navigated PAK Needles are single use surgical instruments composed of stainless steel and plastic. They are sterile packaged. The devices are comprised of three main components: the cannula, stylet assembly, and tracker subassembly.

There are two devices in the family: the BE-ST Navigated NIM® PAK Needle and the BE-ST Navigated PAK Needle. The BE-ST Navigated NIM® PAK Needle is an accessory to the Medtronic StealthStation® System and is intended for use as a stimulating accessory to the Medtronic NIM® System. The BE-ST Navigated PAK Needle is an accessory to the Medtronic StealthStation® System.

The only significant differences between the two subject devices are the electrical insulation on the cannula and the connection to the NIM® System. The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but is not an accessory to the Medtronic NIM® system and therefore cannot be used for nerve monitoring.

The provided document is a 510(k) Summary for the BE-ST Navigated PAK Needles. It describes the device, its indications for use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner for most tests (e.g., minimum tensile strength), but rather by concluding that the devices "passed" or "successfully completed" the tests. However, one specific quantitative acceptance criterion is mentioned: the device navigational accuracy met "the confidence/reliability tolerance interval requirement." Another is the "SAL of 10-6" for ETO sterilization.

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

The document does not explicitly state the sample sizes used for most of the performance tests. For "functional use and reliability testing," it mentions "the subject devices and the predicate devices" without specifying the number of units. Similarly, for biocompatibility, packaging, and age testing, only "finished devices" or "devices" are mentioned.

The data provenance is retrospective as the tests were conducted as part of the 510(k) submission process, using manufactured devices. There is no mention of country of origin of the data; it's implied to be from the manufacturer's testing or contracted labs.

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

This information is not applicable in the context of this device. The BE-ST Navigated PAK Needles are medical instruments for navigated pedicle pilot hole preparation and nerve monitoring. The "ground truth" for the performance tests is established through objective engineering and biological measurements (e.g., impact forces, electrical continuity, cell viability, sterility levels, accuracy measurements against a known standard from the StealthStation® System), not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to the type of testing described for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between readers need to be resolved. The performance data here is based on objective bench and lab testing.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves multiple human readers evaluating medical cases, often to compare the effectiveness of a diagnostic tool or AI assistance. The BE-ST Navigated PAK Needles are surgical instruments, not diagnostic AI software, and their evaluation focuses on technical performance and safety, not human interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study, in the sense of an algorithm operating independently, was not performed because the device is a physical surgical instrument. However, the "device navigational accuracy and compatibility with Medtronic StealthStation® System" testing can be considered an evaluation of the device's technical performance in conjunction with the StealthStation® System, without explicit human variability being the primary focus of the test itself. The device's accuracy was tested against the StealthStation® system's inherent accuracy criteria.

7. Type of Ground Truth Used

For most tests, the "ground truth" refers to established engineering standards, material specifications, and biological safety limits.

• Functional Use & Reliability: Engineering specifications, predicate device performance, basic principles of mechanical and electrical integrity.
• Biocompatibility: ISO 10993 standards (e.g., in vitro cytotoxicity, irritation, systemic toxicity, hemolysis, sensitization, pyrogenicity).
• Sterilization: ISO 11135 standard (SAL of 10⁻⁶).
• Packaging: ISTA 1C Test standard, ISO 11607 standards, and typical packaging integrity tests (dye injection, seal strength).
• Age Testing: Controlled accelerated aging, followed by re-evaluation against functional and packaging integrity benchmarks.
• Surface Area: Dimensional measurements and comparison to predicate.
• Navigational Accuracy: The accuracy criteria set forth by the Medtronic StealthStation® System served as the ground truth/reference for navigational accuracy.

8. Sample Size for the Training Set

This information is not applicable. The BE-ST Navigated PAK Needles are physical medical devices, not AI/machine learning algorithms that require training sets. The development and testing revolve around engineering principles, materials science, and biological safety, not data-driven model training.

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

This information is not applicable as there is no training set for a physical medical device.

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