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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 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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