(159 days)
The KBA3D v2.0.0 is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.
The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bending algorithm is intended for patients older than 22 years old.
The subject device KBA3D v2.0.0 is a SaaS software solution developed by S.M.A.I.O for the medical community; it is a second, independent version of the original KBA3D cleared by FDA in K213975. The current version of the KBA3D software is v.2.0.0. The user needs and requirements of the subject device were jointly defined by S.M.A.I.O and NuVasive. The software is intended to view images, perform spine related measurements, and plan surgical procedures such as osteotomies of the spine and templating of implants (screws, cages, rods).
KBA3D V2.0.0 software can be used by health professionals (orthopedic surgeons, radiologists, neurosurgeons) and service providers (imaging technicians, clinical study technicians) who are trained in spine imaging and pathologies. The KBA3D V2.0.0 software is intended for patients requiring measurements and planning of surgical procedures. KBA3D v2.0.0 aims to achieve three objectives:
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- From two perpendicular patient's standing x-rays including patient's spine and pelvis from the femoral heads to the cervical levels, provide 3D scaled representation of the femoral heads, sacral plate, and vertebral bodies. Provide related shape and positioning parameters measurements (disc/vertebra/height/angulation), main curvatures description and global balance assessment.
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- Simulate potential effects of a spine surgery on spinopelvic alignment and provide related shape and positioning parameters calculation.
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- Visualize scaled representation of implant range (pedicle screws, interbody cages, union rods) relative to spinopelvic representation (pre-op versus realigned) to establish possible implant selection scenarios.
The software is not intended to predict the results of surgery as S.M.A.I.O does not provide tools to carry out planning. Therefore, regarding implant sizing, positioning, and correction impacts, accuracy levels provided by S.M.A.I.O are solely based on theoretical calculations that are not correlated to the output of surgery. KBA3D V2.0.0 provides scaled and simplified representations of the screws and cages relative to the patient's spine and pelvis.
Bendini service (part of NuVasive Pulse System, K210574, reference device):
- The first request from the software to the Bendini system enables the software to retrieve the most up-to-date benders/rods configuration file.
- A second request from the software to the Bendini system enables the software to obtain specific bending instructions for the rod.
Note: The Bendini Rod Bending algorithm is intended for patients older than 22 years old. The NuVasive Bendini Web App service is comprised of an API REST web service that facilities outside clients to utilize the NuVasive Bending algorithm. This algorithm is identical to the Bendini algorithm in K210574 for the NuVasive Pulse System and is hosted using the Microsoft Azure App Service. The KEOPS database manages connection to the software, patient data, and storage of data (X-rays and simulations).
Here's a breakdown of the acceptance criteria and study information for the KBA3D v2.0.0 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Measurement | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| 3D Algorithm Reconstruction (Vertebral Body Dimensions from 2D Images vs. CT-Scan) | Max deviation |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).