(25 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, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) and TriFit CF (K173880) 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 consists of the OPS™ Plan Report and the OPS™ Plan Appendix. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components. OPS™ Plan Appendix presents the steps taken by the Engineer on behalf of the Surgeon during the preoperative planning process, which include the identification of anatomical landmarks as well as sizing and positioning of the implants.
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 Corin 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 OPS™ Plan was originally cleared in K171847. The purpose of this submission is to include TriFit CF (K173880) to the Femoral Hip systems intended to be used with the OPS™ Plan.
The design and all the other compatible components for use with the OPS™ Plan subject of this submission are identical to that of the predicate device K171847.
The provided text describes the Corin Optimized Positioning System (OPS) Plan, a pre-operative planning tool for total hip arthroplasty. However, it explicitly states that clinical testing was not necessary for this Traditional 510(k) submission. Instead, the submission relies on non-clinical testing to demonstrate safety and effectiveness.
Therefore, the following information, which typically relies on clinical or comparative studies, is either not applicable or not detailed in the provided document:
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A table of acceptance criteria and the reported device performance: The document does not provide a table with specific acceptance criteria (e.g., minimum accuracy percentages, error margins) and reported performance against those criteria as would be found in a clinical study report. It generally states that "accuracy and performance of the system is adequate to perform as intended."
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample size, data provenance, or whether data was retrospective or prospective from a test set for clinical performance are provided, as no clinical testing was performed for this submission.
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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): Not applicable, as no external expert-validated test set for clinical performance is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication is described.
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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: Not applicable. The device is a planning tool, and a clinical MRMC study evaluating human reader improvement with AI assistance is not mentioned. The "Surgeon does not actively interact with the image processing, implant positioning and/or report generation" (page 4), suggesting a standalone planning process rather than an AI-assisted reading scenario for the surgeon.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Image processing is completed by an Corin 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..." This describes a process where the engineer uses the system to generate a plan, which the surgeon then approves. While not a fully automated 'algorithm only' in the sense of no human intervention, it is a standalone planning tool that an engineer operates, rather than direct human-in-the-loop diagnostic assistance. The non-clinical testing assessed the "processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components," which supports a standalone performance claim for the system's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Since clinical testing was not performed and no direct ground truth for a clinical comparison is mentioned, the ground truth for the non-clinical testing would likely be based on engineering benchmarks, simulated scenarios, or established anatomical measurements against which the system's output (implant selection, sizing, placement) could be validated for accuracy, repeatability, and reproducibility. These details are not elaborated in the provided text.
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The sample size for the training set: The document does not mention a training set size, as it focuses on the regulatory submission and non-clinical testing, not on the underlying machine learning model development (if any, as the system predates this specific submission). The device was originally cleared in K171847, and this submission is for an expanded list of compatible femoral hip stems.
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How the ground truth for the training set was established: Not applicable, as details on a training set are not provided.
Summary from the provided text regarding acceptance criteria and study:
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Acceptance Criteria (Implied / Stated Goals):
- Accuracy: The system must produce accurate implant selection, sizing, and placement of components.
- Repeatability: The system must produce repeatable results.
- Reproducibility: The system must produce reproducible results.
- Usability: The OPS™ Plan provided to the Surgeon must be usable.
- Adequate Performance: The system's accuracy and performance must be adequate to perform its intended use as a pre-operative planning tool.
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Reported Device Performance (from Non-Clinical Testing):
- "Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components, and the usability of the OPS™ Plan that is provided to the Surgeon. Testing verified that the accuracy and performance of the system is adequate to perform as intended." (Page 5)
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Study That Proves the Device Meets Acceptance Criteria:
- Title/Type: Non-Clinical Testing.
- Objective: To assess safety and effectiveness by demonstrating accurate, repeatable, and reproducible implant selection, sizing, and placement, and usability of the OPS™ Plan.
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
- Number of Experts for Ground Truth: Not specified.
- Qualifications of Experts: Not specified.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes (demonstrated through non-clinical testing assessing the system's processing of patient imaging to produce results).
- Type of Ground Truth: Not explicitly stated but inferred to be engineering benchmarks, simulated scenarios, or established anatomical measurements for validating the accuracy, repeatability, and reproducibility of the system's output.
- Training Set Sample Size: Not specified.
- Ground Truth for Training Set: Not specified.
It is important to note that this submission (K183038) is for an update to an already cleared device (K171847) to include a new femoral hip stem. The non-clinical testing mentioned reaffirms the system's core functionalities in light of this update, rather than being a comprehensive clinical validation of a new or significantly altered device.
§ 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).