(30 days)
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This condics a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer a generated image for precise bone preparation during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in vhich the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomic of structure, such as a long bone, can be identified relative to a CT or MR hased model of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
- Total Joint Replacement (TJR)
- Revision Surgery of TJR .
- Tumor resection and Bone/Joint Reconstruction
The DePuy Ci ™ Hip Instruments are reusable manual orthopaedic surgical instruments modified with a navigation adapter for use with BrainLAB's VectorVision Hip version software on the DePuy Ci hardware platform.
These instruments are designed for either manual or computer navigation use. The BrainLAB Starlock arrays and marble-sized optical spheres enable the instruments to interface with computer assisted imaging hardware and software. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intra-operatively during surgery.
Instruments are tracked by marble sized marker spheres attached to a reference array creating a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. A virtual 3-D computer image is generated enabling a surgeon to accurately navigate the position of instrumentation for precise bone preparation during intraoperative hip surgery.
This document does not contain the information required to populate the requested table and sections regarding acceptance criteria and a study proving the device meets these criteria.
The provided text is a 510(k) summary for the DePuy Ci™ Hip Instrumentation. It focuses on device description, intended use, and establishing substantial equivalence to predicate devices (DePuy CAS Hip Instrumentation and BrainLAB VectorVision Hip Software).
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details of any specific study (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set details.
The document primarily states that the device is substantially equivalent to existing devices based on similarities in design, intended use, materials, sterility, and computer navigation, implying that its performance is implicitly considered acceptable because it's similar to already cleared 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).