(43 days)
Intended Use: The Stryker Navigation System - CT Based Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.
Indications for Use: The system should be operated only by trained personnel such as orthopedic surgeons and clinic staff. The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures: Any form of Total Hip Athroplasty (THA), e.g. open or minimal-invasive. Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities. Revisions.
The CT Based Hip Module is part of the product series of the Stryker Navigation System. The system comprises a computer assisted hip implantation control and monitoring module based on a wireless video-optical tracking localization device for the use in total hip arthroplasty. The CT-Based Hip module will allow the importation of CT scans into the system. Unique to other hip navigators the Stryker system provides Surgeons with pre-operative, intraoperative and postimplantation assessments of the patient's joint kinematics. The system supports different surgical protocols. The order of femoral and acetabular preparation is configurable as well as other user specific settings. The user settings adjust the workflow and the graphical interface sequence in order to match the user habits.
This 510(k) submission for the Stryker Navigation System - CT Based Hip Module (K050615) is a premarket notification for a navigation system, not a device that relies on AI/ML. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML-specific metrics (like MRMC studies, standalone performance, training data, etc.) is not applicable to this document.
The document focuses on demonstrating substantial equivalence to previously cleared devices based on intended use, safety, and effectiveness. It primarily describes the device's functionality and its intended use as a planning and intraoperative guidance system for total hip arthroplasty (THA) and other orthopedic procedures.
Here's an analysis based on the provided text, explaining why the requested AI/ML-centric information is not present:
Absence of AI/ML-specific information:
- No mention of AI/ML components: The device description ("computer assisted hip implantation control and monitoring module based on a wireless video-optical tracking localization device") does not suggest the use of AI/ML. It describes a computer-assisted system with optics and tracking, which are traditional navigation technologies.
- Focus on substantial equivalence: The core of the submission's argument is that the device is "equivalent in intended use, safety, and effectiveness to existing devices." This implies that the device operates on established principles already accepted by regulatory bodies, rather than introducing novel AI/ML functionalities that would require extensive validation against new criteria.
- No performance metrics or studies: The document does not provide any detailed performance metrics, acceptance criteria, or specific study results (clinical or technical) that would be expected for a novel AI/ML device attempting to prove its efficacy and safety. The safety and effectiveness section simply states that it "do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."
- No ground truth, sample sizes, experts, or adjudication: These elements are critical for validating AI/ML performance against a reliable reference. Their absence further confirms that the device is not an AI/ML product as defined by your query's requirements.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets them because such information is not contained within this document. The document pertains to a traditional medical navigation system and not an AI/ML-based device.
§ 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).