(90 days)
The Q Guidance System, when used with the Spine Guidance 5.2 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.
The system is indicated for any surgical procedure on the spine 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 such as the skull, pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
· Screw and Needle Placement in the spine or pelvis
· Bone resection in the spine
The Mako Spine System is intended to be used as an accessory to the Stryker Spine Guidance System. It is intended to be used to facilitate preparation and placement of screws of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients.
The Mako Spine System is intended to be used as part of the Stryker Spine Guidance System, which is indicated for any surgical procedure on the spine 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 such as the spine or pelvis can be identified.
The Stryker System 8 Dual Trigger Rotary Battery Powered Heavy Duty System is intended for use in the drilling, reaming, and decorticating of bone and other bone related tissue in a variety of surgical procedures. They are also usable in the placement of screws, wires, pins, and other fixation devices.
The Stryker System 8 Dual Trigger Rotary Battery Powered Heavy Duty System, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.
The Spine Guidance System is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery on the spine and pelvis. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery. The system is comprised of the Spine Guidance 5.2 Software, Q Guidance System (computer platform), Mako Spine System, navigated accessories/ instruments (e.g., patient/ instrument trackers, pointers), and various system components (e.g., trackers, calibration instruments, etc.).
The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies as well as haptic trajectory guidance to facilitate pedicle preparation and screw placement using Mako Spine System.
The Spine Guidance 5.2 Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via wireless optical tracking technology. The software provides the functions to perform the indicated navigated spine surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated spine surgical procedures.
The Mako Spine System is an accessory to the subject Spine Guidance 5.2 (SG5.2) Software and extends the functionality of the SG5.2 Software to provide trajectory guidance to align the End Effector tube with a pre-planned screw trajectory to facilitate preparation and placement of screws in the non-cervical spine. The Mako Spine System includes a Mako 3.5 Robotic arm, new dedicated instrumentations (i.e. Spine Pedicle End Effector, Spine Pedicle Registration Tool, Pedicle Instruments, etc.), and previously cleared compatible instruments (i.e. Vizadisc, Rio System Quick Connect Base Array, End Effector Tracker Array, Calibration End-Effector, etc.). Mako 3.5 Robotic Arm is connected to the existing Q Guidance System (K233542) via Mako ethernet cable.
The System 8 Dual Trigger Rotary Handpiece is used in the drilling, reaming, and decorticating of bone and other bone related tissue in a variety of surgical procedures. It is also used in the placement of screws, wires, pins, and other fixation devices. The handpiece, when used with a compatible instrument tracker, can be used with the Spine Guidance 5.2 Software to facilitate preparation and placement of screws using Stryker Spine implant systems.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, the document is an FDA 510(k) clearance letter for the Stryker Q Guidance System, Mako Spine System, and System 8 Rotary Handpiece.
A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with specific statistical acceptance criteria as would be found in a clinical trial or a robust standalone AI performance study.
The document mentions "non-clinical performance testing" which includes:
- Software testing as required by IEC 623304 and FDA Guidance on General Principles of Software Validation.
- System accuracy verification per ASTM F2554.
- Full system cadaver validation.
- Biocompatibility verification according to ISO 10993-1:2018.
- Sterilization validation of reusable devices per ISO 17665-1.
- Shelf-life validated per ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980-21.
- Electrical Safety and Electromagnetic Compatibility verification to IEC 60601-1 and IEC 60601-1-2.
However, it does not provide details on:
- A table of acceptance criteria and reported device performance. While "System accuracy verification per ASTM F2554" is mentioned, the specific metrics, thresholds, and results are not provided.
- Sample size, data provenance, number of experts, adjudication methods for any test set, or details of any MRMC study. The document states "No clinical testing was required to support this submission," which means there would be no human reader study or corresponding ground truth establishment on a clinical test set as described in your prompt.
- Standalone (algorithm-only) performance results, as this device is a guidance system, not a diagnostic AI algorithm.
- Type of ground truth used in the context of an AI performance study, as such a study was not required or detailed.
- Sample size for the training set or how ground truth was established for it. This information pertains to AI model development, which is not the focus of this 510(k) submission document.
In summary, based on the provided text, it is not possible to answer your questions regarding acceptance criteria, performance data, test set details, ground truth establishment, or AI-specific study methodologies, because the document is a 510(k) clearance that explicitly states "No clinical testing was required to support this submission" and focuses on demonstrating substantial equivalence through non-clinical performance and other regulatory compliance tests.
The document does describe the Indications for Use for the Q Guidance System and Mako Spine System, which outlines the intended purpose and patient population. It also provides a Summary of Technological Characteristics comparing the subject devices to predicate devices. However, this is for demonstration of substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and results as typically seen for AI/ML devices.
§ 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).