(137 days)
The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.
The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach.
The Corin OPSTM Femoral PSI is intended for single use only.
The Corin Optimized Positioning System (OPS™) Femoral consists of Femoral Patient Specific Instruments (PSI) and reusable instrumentation. The Femoral Patient Specific Instruments include a Femoral Guide and an optional Trial Femoral Head (Bone Model).
The Femoral Guide is shape-matched to the patient's femoral anatomy and provides a guide for the femoral neck osteotomy during total hip arthroplasty. The planned femoral resection, or target osteotomy, is defined by the previously cleared OPS™ Plan (K171847). The OPS™ Plan is a pre-operative tool used by the Surgeon for the selection, sizing and placement of implant components using anatomical landmarks of the femur and pelvis identified from pre-operative CT scan and AP X-ray. The OPS™ Plan was previously cleared under K171847 and is not submitted for review in this 510k submission.
The provided text does not contain detailed acceptance criteria and a study proving the device meets them in the format requested. The document is an FDA 510(k) clearance letter for the Corin Optimized Positioning System (OPS) Femoral. While it mentions non-clinical testing for accuracy and performance, it does not provide the specific metrics or the details of the study.
However, I can extract the information that is present and indicate where details are missing based on your request.
Missing Information:
The document does not provide:
- A table of actual acceptance criteria values.
- Specific reported device performance values against detailed criteria.
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts, their qualifications, or adjudication method for ground truth establishment.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
- Details on standalone algorithm performance.
- Specific type of ground truth used (beyond "clinical accuracy").
- Sample size for the training set.
- Specifics on how ground truth for the training set was established.
Information Extracted from the Document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Quantitative Assessments of Clinical Accuracy: | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." (Specific metrics and values are not provided in this document.) |
| Biocompatibility: | "Testing completed." (Specific metrics and values are not provided in this document.) |
| Dimensional Stability: | "Testing completed." (Specific metrics and values are not provided in this document.) |
| Packaging, Distribution, Cleaning, Sterilization Validation: | "Testing completed." (Specific metrics and values are not provided in this document.) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The manufacturer (Optimized Ortho Pty Ltd) is based in Pymble NSW, Australia, which might suggest data could originate from Australia, but this is not confirmed. The document only mentions "Non-clinical testing was performed..." without detailing data sources.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document refers to "quantitative assessments of clinical accuracy" but does not detail the method of ground truth establishment or the involvement of experts.
4. Adjudication method for the test set:
- Not specified.
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 specified. This document is for the "Corin Optimized Positioning System (OPS) Femoral", which is described as a patient-specific surgical instrument and planning system (OPS™ Plan). It does not explicitly involve an "AI" component in the context of diagnostic image analysis or human reader improvement, but rather an instrument to deliver a target osteotomy based on a pre-operative plan.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device (OPS™ Femoral) is described as a "patient-specific surgical instrument" that assists a surgeon in delivering a target osteotomy based on a pre-operative plan generated by the "OPS™ Plan". This implies a "human-in-the-loop" system where the instrument guides the surgeon. A "standalone" performance for the instrument itself (without human interaction) would not be directly applicable in the same way as a diagnostic AI algorithm. The accuracy of the instrument in performing its guiding function was tested, but details are not provided.
7. The type of ground truth used:
- The document mentions "quantitative assessments of clinical accuracy." This suggests a comparison against a reference standard or ideal measurement, but the specific nature of this ground truth (e.g., direct measurement, expert opinion, high-resolution imaging) is not detailed. It's implied to be related to the accuracy of the femoral neck osteotomy.
8. The sample size for the training set:
- Not specified. The document does not mention a "training set" in the context of an algorithm that learns from data. The system uses pre-operative CT scans and AP X-rays to plan.
9. How the ground truth for the training set was established:
- Not applicable as a "training set" for an algorithm, as traditionally understood, is not explicitly mentioned. The "OPS™ Plan" (K171847) is a pre-operative tool for implant selection, sizing, and placement based on anatomical landmarks. The details of its development and validation are outside the scope of this particular 510(k) summary (K181061).
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.