(144 days)
Navigated Everest Instruments
The Navigated Everest Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Everest Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Everest Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Everest Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Mesa Instruments
The Navigated Mesa Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Mesa Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Mesa Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Mesa Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Yukon Instruments
The Navigated Yukon Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Yukon Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Yukon Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Yukon Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Xia 4.5- Xia CT Taps
The Navigated Xia 4.5- Xia CT Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 4.5- Xia CT Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 4.5- Xia CT Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 4.5- Xia CT Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Xia 3- Serrato Deformity Screwdriver
The Navigated Xia 3- Serrato Deformity Screwdriver is intended to be used as an accessory to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3-Serrato Deformity Screwdriver may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.
The Navigated Xia 3- Serrato Deformity Screwdriver is intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine XIA® 3 and ES2® Spinal Fixation Systems using the Stryker Spine Navigation System.
Navigated Spine Instruments are nonsterile, reusable surgical instruments (screw inserters and taps) intended to be used when implanting previously cleared components of Mesa, Everest, Yukon, Xia 3, Xia 4.5, and ES2. These instruments are intended to be used with the Stryker Spine Navigation System.
The provided text describes the regulatory clearance for "Navigated Spine Instruments" by Stryker Spine but does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria.
The "Summary of the Performance Data" section generically states: "Performance testing was conducted to ensure that the Navigated Spine Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Stryker Spine Navigation System using the Rotational Navigation Adapter and associated trackers, and to demonstrate substantial equivalence to the predicate device. The performance of Navigated Spine Instruments has met all acceptance criteria."
This statement confirms that performance testing was done and acceptance criteria were met, but it does not provide the specifics of:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Therefore, based solely on the provided text, I cannot complete the request. The document describes the device, its intended use, and its equivalence to predicate devices, but it does not delve into the specifics of the performance study's methodology or detailed results.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).