(90 days)
CUPTIMIZE™ Advanced is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component.
It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
CUPTIMIZE™ Advanced is a software as a medical device (SaMD) system that provides acetabular component orientation data for hip replacement surgery. The software guides the user through a workflow that involves positioning digital annotations on preoperative patient radiographic images. CUPTIMIZE™ Advanced utilizes digital annotations to describe the range of motion of the pelvis and provides an orientation of the acetabular component which reduces risk of edge loading and implant impingement. The system also provides warnings for patients with high or low pelvic mobility and high or low pelvic incidence.
CUPTIMIZE™ Advanced will include a pre-operative module that determines spinopelvic tilt relationships and data to provide an implant orientation plan, as well as an intra-operative verification capability that will allow the current implant orientation to be assessed against the plan.
The document provided outlines the K231503 510(k) premarket notification for the "CUPTIMIZE™ Advanced" device. It certifies that the device has undergone non-clinical and/or clinical tests to show its substantial equivalence in safety and efficacy to its predecessor. While the document mentions general categories of tests (model verification, system verification, system validation, and usability evaluation), it does not provide details on specific acceptance criteria or the reported device performance metrics in a table format. It also explicitly states that "Clinical testing was not required to demonstrate substantial equivalence."
Therefore, based solely on the provided text, I cannot complete all sections of your request.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states that tests were performed but does not list specific acceptance criteria or quantitative performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No details on sample sizes, data provenance, or study design are given for any test sets.
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):
- Cannot be provided. No information on expert involvement for ground truth establishment for test sets is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No details on adjudication methods are given.
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:
- Cannot be provided. The document states "Clinical testing was not required," implying a MRMC comparative effectiveness study was not performed or not deemed necessary for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be definitively stated based on the provided text alone. While "system validation tests" are mentioned, there's no explicit confirmation or exclusion of a standalone algorithm-only performance study or its results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. The document does not specify the type of ground truth used for any testing.
8. The sample size for the training set:
- Cannot be provided. The document makes no mention of training sets or their sizes.
9. How the ground truth for the training set was established:
- Cannot be provided. As no training set information is available, how its ground truth was established is also not mentioned.
In summary, the provided FDA 510(k) letter and summary describe the device, its intended use, and its substantial equivalence to a predicate device, noting that non-clinical tests were performed. However, it does not offer the detailed study design, acceptance criteria, and performance results requested.
§ 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).