(239 days)
OPSReView™ is intended to be used as a postoperative tool for visualising and quantifying component alignment to aid in the analysis of hip alignment following hip replacement surgery.
OPSReView™ provides the surgeon with information to the in-situ implant placement as well as associated functional analysis and 3D biomechanical measurements, based on landmarks derived from patient specific postoperative imaging.
OPSReView™ is an image analysis tool that provides surgeons with postoperative information regarding the femoral stem and acetabular cup orientations and patient pelvic parameters following hip replacement surgery. OPSReView™ is provided to the surgeon in the form of a static PDF report that displays the results of the analysis and uses post-operative CT and X-ray imaging as inputs.
The information provided in the OPS™ ReView report includes the patient's pelvic parameters, in-situ implant measurement describing the in-situ implant placement and post-operative radiographic images.
The implant parameters, including 3D geometry and associated landmarks, required to calculate the in-situ implant measurements are contained within a controlled database.
The provided text describes the OPSReView™ device and its regulatory clearance (K193042) but does not include the detailed information required to fill out the table of acceptance criteria or the specific details of a study proving the device meets those criteria. The document explicitly states that "Non-clinical testing was performed to assess the accuracy of the device, the usability of the OPS™ ReView report provided to the Surgeon, and to demonstrate that the software utilized in the device functions as intended" and "Clinical testing was not necessary for this Traditional 510(k)."
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why the requested information cannot be extracted:
- Table of acceptance criteria and reported device performance: This information is not present. The document mentions non-clinical testing for accuracy and usability but does not provide specific metrics or acceptance thresholds.
- Sample size for the test set and data provenance: Not mentioned.
- Number of experts and their qualifications for ground truth: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document states "Clinical testing was not necessary for this Traditional 510(k)," implying no such comparative study was performed (or at least not for this submission).
- Standalone performance study: The document states "Non-clinical testing was performed to assess the accuracy of the device," which suggests some form of standalone evaluation, but no details of the study, its results, or specific metrics are provided.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
§ 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).