(288 days)
The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.
The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.
The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components.
The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an OPS™ Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.
The provided text describes the Corin Optimized Positioning System (OPS™) Plan, which is a pre-operative templating tool for primary total hip arthroplasty. Here's a breakdown of the acceptance criteria and the study information based on the provided document:
Acceptance Criteria and Device Performance for Corin Optimized Positioning System (OPS™) Plan
The document does not explicitly state numerical acceptance criteria in a table format. However, it outlines the general performance aspects that were tested.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance/Conclusion |
|---|---|---|
| Accuracy | Ability to produce accurate implant selection, sizing, and placement of components. | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." The system uses CT scans for 3D patient-specific bone models and X-ray imaging for bony landmarks to achieve this. |
| Repeatability | Consistency of results when the same inputs are processed multiple times. | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
| Reproducibility | Consistency of results when different operators or conditions produce the outputs. | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
| Usability | Ease of use and effectiveness of the OPS™ Plan provided to the Surgeon. | "Testing...demonstrate...the usability of the OPS™ Plan that is provided to the Surgeon." No specific metrics are given, but implies it was found acceptable. |
| Safety & Effectiveness | No new issues in terms of safety or effectiveness compared to the predicate device. | "The differences between the device and its predicate device raise no new issues in terms of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size (number of cases or patients) used for the non-clinical testing.
- Data Provenance: Not explicitly stated. The manufacturer, Optimized Ortho Pty Ltd, is located in Pymble NSW, Australia, suggesting the data may originate from Australia or other regions where Corin operates. The document only mentions "patient imaging in DICOM format are electronically transferred to the manufacturer." It does not specify if these were retrospective or prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the non-clinical testing. The process described for generating the OPS™ Plan states that "Image processing is completed by an OPS™ Simulation Engineer," and "Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results." This implies a Surgeon's clinical judgment is the ultimate arbiter, but detailed information about their role in establishing ground truth for testing is missing.
4. Adjudication Method for the Test Set
The document does not mention a formal adjudication method (e.g., 2+1, 3+1). The process involves an "OPS™ Simulation Engineer" generating the plan and the "Surgeon" confirming final acceptance. For testing purposes, the method by which ground truth was definitively established from multiple expert opinions is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." The testing described is "Non-Clinical testing."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device is described as a "pre-operative templating tool" where "Image processing is completed by an OPS™ Simulation Engineer," and the "Surgeon does not actively interact with the image processing, implant positioning and/or report generation." This indicates a human (the OPS™ Simulation Engineer) is in the loop during the generation of the plan. Therefore, a purely standalone algorithm evaluation without human interaction is not explicitly described or implied for the final output generation. However, the "accuracy, repeatability and reproducibility" testing could have involved testing specific algorithmic components in a standalone manner, but the overall system performance evaluated includes human involvement.
7. The Type of Ground Truth Used
The type of ground truth used for non-clinical testing is implied to be based on established anatomical landmarks and surgical planning principles, likely validated by expert surgical opinion or established surgical methodology. The document mentions "selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray." However, it does not explicitly state whether this involved pathology, outcomes data, or a formal expert consensus process as the ground truth standard for the testing.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set was Established
The document does not provide any information on how ground truth was established for a training set. Given that it's a 510(k) submission not requiring clinical trials, and the process involves human engineers and surgeon confirmation, it's possible that a formal machine learning training set with expert-labeled ground truth in the typical sense was not explicitly detailed or a primary focus of the submission documentation provided.
§ 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).