Search Results

BrainLAB hip unlimited is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision or a Ci™ workstation or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface.

The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement (TJR) Revision surgery of TJR Minimally Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction

BrainLAB hip unlimited is intended to enable operational planning and navigation in orthopedic total hip replacement surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is either generated through acquiring multiple landmarks on the bone surface or on patient's intra-operative acquired fluoroscopic images. BrainLAB hip unlimited uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem broach handles and the implant, to the planned position.

BrainLAB hip unlimited allows 3-dimensional reconstruction of the relevant anatomical axes and planes of the pelvis and femur and alignment of the implants. The BrainLAB hip unlimited software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon. The BrainLAB hip unlimited software registers the patient data needed for planning and navigating the surgery intra-operatively without CT-based imaging. The system can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.

The provided document is a 510(k) summary for the BrainLAB hip unlimited and Ci hip unlimited systems. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the manner typically seen for novel AI/machine learning devices.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance directly from a standalone diagnostic study.

Instead, the submission states that:

• "BrainLAB hip unlimited has been verified and validated according to BrainLAB's procedures for product design and development."
• "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate devices."

The following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance
• Sample sizes used for the test set and data provenance (country of origin, retrospective/prospective)
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (e.g., pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to existing, legally marketed devices (predicates) through technical comparisons and verification/validation processes as per the manufacturer's internal procedures. It does not provide a detailed, independent clinical or performance study with numerical performance metrics and acceptance criteria in the format typically requested for AI/ML device assessments.

Ask a specific question about this device