Search Results

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 discectorny 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 precalibrated with 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 Instrument, when used with UNAS, can be 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.

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.
The Discectomy Navigation Ready Instruments are part of the DePuy Synthes Navigation Ready Instruments Portfolio. The instruments include Cobb Elevators, Curettes and a Bone Graft Delivery Device.

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 Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays, ●
• 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 Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only 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.

The provided text is a 510(k) summary for the Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set. It details the device description, indications for use, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria or a study proving that the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth establishment, or human reader studies.

The performance data listed does not relate to an AI/ML algorithm. Instead, it focuses on the physical and functional aspects of the surgical instruments and their compatibility with navigation systems. Therefore, I cannot extract the information required by your prompt, as the provided document does not describe a study involving AI/ML.

Here's why the prompt's specific requirements cannot be met by the provided text:

• AI/ML Performance Metrics (e.g., Sensitivity, Specificity, AUC): Not present. The "Performance Data" section discusses "Accuracy Verification" but this refers to the accuracy of the navigation system's ability to track the physical instruments, not the accuracy of an AI algorithm in diagnosing or classifying medical images.
• Sample size for test set, data provenance: Not present, as there's no AI test set.
• Number of experts, qualifications, adjudication method: Not present, as there's no expert review for AI-generated output.
• Multi-Reader Multi-Case (MRMC) study: Not present, as there is no AI assistance for human readers mentioned.
• Standalone (algorithm-only) performance: Not present, as no AI algorithm is detailed.
• Type of ground truth (pathology, outcomes data, etc.): Not present, as there's no AI model producing diagnostic or prognostic output.
• Training set size and ground truth for training set: Not present, as there's no AI model that requires training data.

The document's "Performance Data" section outlines the following evaluations:

• Accuracy Verification:
  • Fulfillment of navigation systems instrument accuracy requirements
  • Instrument Length Comparison to Predicate Device
  • Array Characteristics Comparison to Predicate Device
• Navigation Connection Repeatability for Pre-Calibrated Instruments
• CAD Model Evaluation
• Simulated Use Evaluation

These are standard engineering and functional performance tests for medical devices, particularly surgical instruments used with navigation systems, and do not involve artificial intelligence or machine learning.

Ask a specific question about this device