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510(k) Data Aggregation
(260 days)
TELIGEN System Navigation Ready Instruments
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:
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Accuracy Verification | Verified through engineering analysis. |
| Navigation System Instrument Accuracy Requirements | Fulfilled navigation systems instrument accuracy requirements as stated by the navigation manufacturer. |
| CAD Model Evaluation | Evaluation performed. (Implies satisfactory evaluation) |
| Simulated Use Evaluation | Evaluation performed. (Implies satisfactory evaluation) |
| Technological Characteristics (Design, Materials, Performance) | Consistent with predicate devices. |
| Intended Use | Consistent with predicate devices. |
| Safety and Effectiveness | Does not raise new questions of safety and effectiveness based on application of recognized consensus standards and design controls. |
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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