(247 days)
The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X- rays and CT imaging scans.
The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.
The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.
The Patient Specific Guides are intended for single use only.
The Corin Optimized Positioning System (OPS) consists of software and hardware components to assist the surgeon in the alignment of components during Total Hip Arthroplasty.
The software component assists the surgeon in determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.
The hardware components assist the surgeon in delivering the target orientation through the use of a Patient Specific Guide and bone model (replica of the patient's acetabulum, into which the guide fits), and associated reusable instrumentation.
The Corin OPS can be used with the Trinity Acetabular System and the respective compatible components.
Here's a breakdown of the acceptance criteria and study information for the Corin Optimized Positioning System (OPS), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Biocompatibility | Raw material biocompatibility performed according to ISO 10993. | Non-clinical testing |
| Mechanical Performance (Patient Specific Guides) | Able to withstand conditions during storage, shipping, distribution, and normal use. No damage or fracture in drop testing. Satisfactory flexural creep. (Specific quantitative metrics not provided) | Non-clinical testing |
| Cleaning and Sterilization (Patient Specific Guides & Reusable Instruments) | Validated. | Non-clinical testing |
| Packaging and Shelf Life (Patient Specific Guides) | Validated. | Non-clinical testing |
| Software Verification and Validation | Completed in accordance with FDA guidance ("General Principles of Software Validation; Final Guidance for Industry and FDA Staff" and "Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices"). | Non-clinical testing |
| Repeatability (Intra-observer variability) of System Performance | Verified adequate to perform as intended. | Cadaver study |
| Reproducibility (Inter-observer variability) of System Performance | Verified adequate to perform as intended. | Cadaver study |
| System Accuracy of Implanted Cup Orientation Relative to Pre-operative Plan | Verified adequate to perform as intended. | Cadaver study |
| Reproducibility and Repeatability of FHA software module and acetabular guide design (processed by multiple operators) | Verified. | Non-clinical testing (specific details of this test, if separate from the cadaver study, are not given) |
2. Sample Size Used for the Test Set and Data Provenance
The text explicitly mentions a cadaver study for device performance verification. However, it does not specify the sample size (i.e., number of cadavers) used. The data provenance is implied to be a laboratory setting (cadaver study). No information is given about the country of origin. The study was conducted retrospectively or prospectively on cadavers for device verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The text does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver study. It states that the study measured "repeatability (intra-observer variability) and reproducibility (inter-observer variability) of the system," which suggests that multiple individuals (likely experts like surgeons or trained technicians) performed measurements to assess variability, but their specific roles in establishing a definitive "ground truth" for the test set are not detailed in the provided summary.
4. Adjudication Method for the Test Set
The text does not explicitly state an adjudication method (e.g., 2+1, 3+1, none). The mention of "repeatability (intra-observer variability) and reproducibility (inter-observer variability)" suggests a comparison among observers' measurements, but how discrepancies or a final "ground truth" were resolved is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not necessary for this Traditional 510(k)." The described studies focus on the device's technical performance and accuracy, not its comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation of the algorithm (software component) was done. The text says:
- "Software verification and validation was completed in accordance with FDA guidance..."
- "Testing was also performed to verify that the FHA software module and acetabular quide design is reproducible and repeatable when processed by multiple operators."
- The system itself is described as assisting in "determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report." This implies the software's ability to generate these outputs on its own.
7. The Type of Ground Truth Used
For the cadaver study, the ground truth was based on the accuracy of the implanted cup orientation relative to the pre-operative plan. This implies that a pre-operative plan (generated by the device's software) served as the target, and the actual physical implantation in the cadaver was measured against this plan. The details of how this "actual" implantation was precisely measured and considered the "ground truth" are not expanded upon (e.g., whether it was through high-precision imaging, direct measurement, etc.).
For the software validation, the ground truth would typically be established through predefined specifications, expected outputs, and comparison against known correct computations or reference data.
8. The Sample Size for the Training Set
The document does not provide information regarding a specific "training set" or its size. This device's purpose (patient-specific surgical instrument based on pre-operative scans) suggests it might not rely on a conventional machine learning model that requires a distinct training/validation/test split of patient data in the typical sense. Instead, its software likely employs computational geometry and image processing algorithms.
If there was an underlying machine learning component used to develop parts of the software (e.g., for automated anatomical landmark identification), this information is not disclosed in the summary.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, the method for establishing its ground truth is also not available in this document.
§ 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.