Search Results

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:

1. 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."

2. 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.

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): Not applicable, as no external expert-validated test set for clinical performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication is described.

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: 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.

6. 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.

7. 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.

8. 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.

9. 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:

• 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.

• 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)

• 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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

The indications for the Corin MetaFix Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union and femoral neck fractures
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The MetaFix Hip is intended for cementless use only.

The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.

This is a 510(k) premarket notification for a medical device called the Corin MetaFix Hip Stem, not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly regarding AI performance, is not applicable.

The document states:

• "Clinical testing was not necessary in this Traditional 510(k)." (Page 4, Section 13)
• The submission is primarily to "modify the labeling to remove an indications for use for the MetaFix Hip Stem, for clarity to ensure safe or effective use." (Page 4)
• The device design and compatible components are "identical to that of the predicate device" (K082525, K120362, K121439, K130634, K131952 and K153381). (Page 4)
• The substantial equivalence is based on similarities in "design, materials, coating, sizes and similar in terms of intended use/indications for use." (Page 4, Section 11)

Therefore, the information for establishing acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details as they relate to an AI/ML device's performance are not provided in this document. The FDA's review concluded substantial equivalence based on non-clinical data and comparison to predicate devices, which is typical for traditional 510(k) submissions of non-AI devices.

Ask a specific question about this device