(192 days)
BrainLAB VectorVision is intended to be an intraoperative image guided localization system. 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 Vector vision workstation 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 appropriate 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
Tumor resection and bone/joint reconstruction
BrainLAB VectorVision® Hip is intended to enable operational planning and navigation in orthopedic and surgical procedures. It links a surgical instrument, tracked by passive markers to virtual computer image space on a patient's preoperative image data or an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Vector Vision® Hip uses the registered patient data to guide the cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. If no implant data is available it is possible to provide information in order to define the implant and the bone orientation as defined by the operating surgeon.
VectorVision® Hip allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis. VectorVision® Hip software has been designed to read in data and perform calculations based on the geometry of implants and instruments if provided by the implant manufacturer and offers to individually choose the type of implants and instruments. VectorVision® Hip software registers the patient data needed for prosthesis implantation using the CT free module. The system can be used for planning and navigating the surgery intraoperatively. Special landmarks and any other anatomical information referring to the patient data can be used additionally for surgery, the patient data is then provided by the CT data stored on a standard data storage media.
The provided text (K040368) is a 510(k) summary for the VectorVision® Hip system. It focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, sample sizes, or ground truth establishment typically found in performance studies for new medical devices.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. A 510(k) often focuses on comparing the new device's features and intended use to a predicate device to argue for substantial equivalence, rather than presenting detailed performance study results against specific acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not provided. The document states that the device "has been verified and validated according to BrainLAB's procedures for product design and development," but no specific test set sample sizes are given for this validation.
- Data provenance: Not provided. No information about country of origin, or if data was retrospective or prospective, is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: Not provided. This document does not describe an MRMC study. The VectorVision® Hip is described as an "intraoperative image guided localization system" that "aids the surgeon to accurately navigate a hip endoprothesis." It's not an AI-driven diagnostic tool where "human readers improve with AI vs without AI assistance" would typically be measured.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Not explicitly stated in the context of an "algorithm only" study. The device is described as an "intraoperative image guided localization system" that assists the surgeon. Its performance is inherently tied to human interaction (the surgeon using the system to navigate). The summary focuses on its function as a navigation aid.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided.
8. The sample size for the training set:
Not applicable/Not provided. This device is described as an image-guided surgery system, not a machine learning model that would typically have a "training set" in the sense of supervised learning. While it processes image data and creates 3D models, the core functionality is navigation and not predictive modeling based on a trained dataset.
9. How the ground truth for the training set was established:
Not applicable/Not provided. (See point 8).
Summary of what the document DOES state regarding verification and validation:
The document briefly mentions:
"VectorVision® Hip has been verified and validated according to BrainLAB's procedures for product design and development. This verification and validation demonstrated the safety and effectiveness of the system."
However, it does not elaborate on the specifics of these verification and validation activities, such as:
- What parameters were measured.
- What the quantitative acceptance criteria were.
- What the results of those measurements were.
- How ground truth was established for any performance testing.
- The exact study design or participant details.
This 510(k) submission primarily relies on demonstrating substantial equivalence to its predicate device (VectorVision® Hip K010602 and Vector Vision® CT-free Knee K021306) rather than providing extensive de novo performance study details.
§ 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).