(219 days)
OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
OPS™ Insight is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patient-specific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and prosthetic impingement detection.
The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPS™ Insight is a closed platform. Please refer to the Instructions for Use for compatible implant systems.
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria, specifically in the format requested. The document is a 510(k) summary for the OPS™ Insight device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed technical report of performance validation.
Here's what can be extracted and what is missing based on your request:
What can be extracted:
- Non-Clinical Testing: "Non-clinical testing was performed to assess the usability and performance of OPS™ Insight software device to demonstrate that the device functions as intended. Software verification and validation testing was conducted according ISO 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
- Clinical Testing: "Clinical testing was not necessary for this Traditional 510(k)."
Information Missing from the provided text:
- Table of acceptance criteria and reported device performance: This detailed information is not present in the 510(k) summary. The summary only states that non-clinical testing was done to show the device "functions as intended" but does not quantify performance against specific criteria.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not necessary for this Traditional 510(k)," which implies no human reader studies (MRMC) were conducted for this submission.
- Standalone (algorithm-only) performance: While non-clinical testing for "performance" was mentioned, the specific metrics, acceptance criteria, and results for standalone algorithmic performance are not detailed.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary of available information:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated or tabulated. The general statement is that non-clinical testing demonstrated the device "functions as intended."
- Study Type: Non-clinical verification and validation testing in accordance with ISO 62304 and FDA guidance for software in medical devices. No clinical testing was deemed necessary.
- Ground Truth: Not detailed.
- Sample Sizes/Expert Details: Not detailed for either test or training sets.
- Human-AI Comparative Effectiveness: No clinical study involved, thus no human-AI comparison.
§ 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).