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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 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.

Ask a specific question about this device

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, 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 navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

The TELIGEN Procedure Kit and the TELIGEN Procedure Kit Pro are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery and navigation.

The TELIGEN Procedure Kit and the TELIGEN Procedure Kit Pro 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 as well as the instruments included in the TELIGEN Procedure Kit.

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.

The provided document, K223108 for the TELIGEN System, primarily focuses on the substantial equivalence of physical medical devices (TELIGEN Access Probe and TELIGEN Clear) which are "Navigation Ready Instruments" used in spinal procedures. It does not describe a study involving an AI/Machine Learning device or software, nor does it provide the detailed performance data, acceptance criteria, ground truth establishment, or study methodologies typically associated with such systems.

Therefore, I cannot extract the information required to populate the fields related to an AI/ML device study, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies.

The document discusses performance data related to the physical instruments:

• Accuracy Verification: Fulfillment of navigation systems instrument accuracy requirements, Instrument Length Comparison to Predicate Device, Array Characteristics Comparison to Predicate Device.
• Rigidity of Connections and Instrument during Use
• CAD Model Evaluation
• Simulated Use Evaluation

These are engineering and mechanical performance tests for physical instruments, not an AI/ML algorithm's diagnostic or assistive performance.

In summary, the provided text does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI/ML device.

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

The TELIGEN Procedure Kit is part of the TELIGEN System. It is a sterile, single use kit intended for use in surgical spinal procedures to allow for access, visualization, discectomy and graft delivery.

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

The TELIGEN HD Camera Control System (CCS) is part of the TELIGEN System. It operates the TELIGEN Camera which is used for illumination and visualization of the surgical site. The image collected at the camera head, is transferred to the CCS and subsequently displayed on the monitor.

I am sorry, but the provided text does not contain any information about acceptance criteria or specific study results to prove device performance. The document is an FDA 510(k) premarket notification letter and a 510(k) Summary for the TELIGEN System. This type of document declares substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and performance data, but it does not typically include detailed clinical study results with specific acceptance criteria and outcome metrics in the way your request describes.

The "Performance Data" section (Section I) only lists the types of evaluations conducted (e.g., Design Verification and Validation Testing, Human Factor/Usability, Electrical Safety, Thermal Safety & EMC Testing, Software and Systems Testing), but it does not provide the results, acceptance criteria, or study details such as sample size, provenance, expert qualifications, or ground truth methodology.

Therefore, I cannot provide the requested table or information regarding the study that proves the device meets acceptance criteria based on the provided text.

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