(157 days)
BrainLAB VectorVision 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 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 Minimal Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction
BrainLAB VectorVision® hip Software is intended to enable operational planning and navigation in orthopedic 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, generated through acquiring multiple landmarks on the bone surface either by a pointer probe or by acquiring pairs of registered fluoroscopic images. VectorVision® hip Software uses the registered landmarks to navigate the needed surgical tools like 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 achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon.
Vector\Vision® hip Software allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the implants. The VectorVision® hip 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. The VectorVision® hip Software registers the patient data needed for planning and navigating the surgery intra-operatively within the CT free module. 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 VectorVision® hip Software, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information about a study proving the device meets acceptance criteria is not explicitly stated in this document.
However, I can extract the information that is present and indicate where the requested details are missing based on the content provided.
Here's an attempt to answer your request based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics (e.g., accuracy in angle or translation measurements) from a validation study. It broadly claims "The validation proves the safety and effectiveness of the system."
| Acceptance Criteria (Not explicitly stated as quantitative values in the document) | Reported Device Performance (Not explicitly stated as quantitative values in the document) |
|---|---|
| Safety and Effectiveness of the system | The validation proves the safety and effectiveness of the system. |
| Substantial equivalence to predicate devices (VectorVision® Hip 3.0, VectorVision® Trauma, Hip Module for the StealthStation System) | The information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with predicate devices. |
| Ability to enable operational planning and navigation in orthopedic surgery | The device is intended to enable operational planning and navigation in orthopedic surgery. |
| Ability to link a surgical instrument, tracked by flexible passive markers, to virtual computer image space on an individual 3D-model. | The device links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone. |
| Ability to register landmarks to navigate surgical tools and implants. | VectorVision® hip Software uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. |
| Ability for 3-dimensional reconstruction of mechanical axes/planes and implant alignment. | VectorVision® hip Software allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the implants. |
| Ability to read in implant and tool data. | The VectorVision® hip Software has been designed to read in data of implants and tools if provided by the implant manufacturer. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on any specific test set, sample size, or data provenance (country of origin, retrospective/prospective). It mentions "BrainLAB VectorVision® hip Software has been verified and validated according to BrainLABs procedures for product design and development," but no specifics on the validation study are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document does not describe an MRMC comparative effectiveness study or assess human reader improvement with AI assistance. The device is a surgical navigation system, not an AI diagnostic tool for interpreting medical images by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly present data from a standalone performance study. The entire description of the device implies human-in-the-loop usage (surgeon using the system to navigate). The "validation" broadly states safety and effectiveness, but no specific study design or results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for any validation testing. It mentions the system's ability to navigate to a "preoperatively or intraoperatively planned position," suggesting that surgical plans and intraoperative reality would be relevant for ground truth, but this is not detailed.
8. The sample size for the training set
The document does not mention a training set or its sample size. This type of detail is typically associated with machine learning model development, which is not the primary focus of this 510(k) summary (focused on a navigation system).
9. How the ground truth for the training set was established
As no training set is mentioned, information on how its ground truth was established is also not present.
§ 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).