(106 days)
360KS Implant Positioning System (IPS) is intended for use as patient-specific surgical planning software to aid orthopaedic surgeons in selection, sizing and placement of knee implant components (femur, tibia and patella implants) provided that the required anatomical landmarks of the knee can be identified on pre-operative CT or MRI scans in patients requiring total knee arthroplasty.
360KS IPS is indicated for use with OMNI Life Science Apex Knee System (#K060192, #K073602, #K080842) and Corin Unity Total Knee System (#K113060).
360KS Implant Positioning System (project name KicoCAD) is a medical device consisting of a software application that provides patient-specific pre-operative surgical planning to assist in the positioning of knee implant components (femur, tibia and patella implants) with compatible knee systems (OMNI Life Science Apex Knee System (#K060192, #K073602, #K080842) and Corin Unity Total Knee System (#K113060)) for total knee arthroplasty.
The software is designed to assist qualified medical professionals with implant component placement, orientation, positioning and size selection. 360KS Implant Positioning System uses a Graphical User Interface (GUI), where any input provided by the user will provide visual feedback reflecting the input provided. Pre-operative plans are available for the femur, tibia and patella.
360KS Implant Positioning System (360KS IPS) requires access to pre-processed patient images (CT or MRI scan) to display three-dimensional images. Pre-processing is done by the engineering team of Kico Knee Innovation Company using Scan IP (510(k) accession number: K142779) to generate a threedimensional bone model and landmarks. The bone model and landmarks are then imported into 360KS IPS and Production Engineers of Kico Knee Innovation Company apply the referring surgeon's prescription for sizing and placement of femoral, tibia and patella components to generate a surgical plan. The process of landmarking and surgical plan creation both have independent QC steps. Once the plan is complete and all QC steps have passed, it is uploaded to the cloud and made available to the referring surgeon. The referring surgeon can then view and modify the plan on their own installation of 360KS Implant Position System.
The 360KS Implant Positioning System is developed within the Integrated Development Environment (IDE) of Visual Studio Professional. The software is written in C# (C Sharp) using .NET framework target version 4.5 in Windows Operating System (OS). 360KS Implant Positioning System is recommended to run on a Windows 7 PC with 2.4 GHz or faster intel Core i5-6300 processor for best performance. The 360KS Implant Positioning System requires 4GB of RAM and a DirectX 9 graphics device with WDDM 1.0 or higher driver. The application requires 10GB of available disk space and the visual display resolution should be set to 1920x1080. An internet connection is also required.
The intended users are production trained engineers and trained orthopaedic surgeons who have experience in total knee replacement. To ensure correct user operation of the software, 360KS Implant Positioning System incorporates simple UI design to make the software more intuitive.
Creation of patient specific guides from the surgical plan is neither part of this device nor submission.
The provided text describes the 360KS Implant Positioning System (IPS), a software application for pre-operative surgical planning in total knee arthroplasty. Here is an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (from "Non-Clinical Testing") |
|---|---|
| Safety | Software verification and validation activities demonstrated that appropriate steps have been taken to ensure mitigation of potential risks. |
| Effectiveness | Software verification and validation testing verified that the accuracy and performance of the system is adequate to perform as intended. |
| Performance | Accuracy and performance are adequate to perform as intended. |
Study to Prove Acceptance Criteria
The document explicitly states that non-clinical testing in the form of software verification and validation was performed to assess the safety and effectiveness of the device.
1. Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated. The document mentions "Software verification and validation testing were conducted" and "Testing included both system and unit level." However, the exact number of test cases or "samples" (in the context of software testing, this refers to test cases rather than patient data) used is not provided.
- Data Provenance: Not applicable in the traditional sense of patient data provenance, as the testing described is software verification and validation, not clinical trials with patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document focuses on software verification and validation. While the software aids surgeons, the testing described isn't about expert performance to establish ground truth for a diagnostic task.
3. Adjudication method for the test set:
- This information is not provided and is generally not applicable to software verification and validation testing, which typically involves comparing software output against predefined specifications or expected outcomes.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states under "Clinical Testing": "This section does not apply. Clinical testing is not required for this Traditional 510(k) device." This indicates that no studies involving human readers, with or without AI assistance, were conducted for regulatory submission.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance assessment was done in the context of software verification and validation. The "Software Verification and Validation Testing" and "Non-Clinical Testing" sections refer to assessing the device's accuracy and performance against specifications and intended functionality. This is essentially an assessment of the algorithm's performance in isolation from a human user, verifying that the software functions as designed. The software itself is the "device," and its standalone performance was evaluated through V&V.
6. The type of ground truth used:
- For software verification and validation, the "ground truth" would be established by the software requirements specifications, design documents, and expected outputs based on those specifications. It's not clinical "expert consensus, pathology, or outcomes data" in this context. The document mentions that the process of landmarking and surgical plan creation both have "independent QC steps," which would contribute to establishing the correctness of the software's output against defined standards.
7. The sample size for the training set:
- This information is not provided. The document does not describe the use of machine learning or AI models in a way that would require a "training set" in the traditional sense of data used to train an algorithm. The 360KS IPS uses an existing 510(k) cleared software (Scan IP, K142779) for pre-processing to generate 3D bone models and landmarks, and the core device then allows for surgical planning based on these models. The development appears to be based on traditional software engineering principles rather than a data-driven machine learning approach requiring a training set.
8. How the ground truth for the training set was established:
- This information is not provided and is not applicable given that no "training set" for a machine learning model is mentioned or implied.
§ 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).