(129 days)
The indications for the Corin TriFit TS 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, femoral neck and trochanteric fractures of the proximal femur
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The TriFit TS Hip is intended for cementless use only.
The Corin TriFit TS Hip is a double tapered-wedge blade stem design manufactured from Ti6Al4V Titanium alloy (ASTM F-136-08) with a layer of commercially pure titanium (BS ISO 5832-2: 1999) and calcium phosphate(BONIT®)coating(ASTM F1609-08) applied. The TriFit TS Hip is available in a range of sizes in standard and lateralized offsets with a 127° CCD angle. The device isintended to be used with Corin 12/14 modular taper heads.
The TriFit TS Hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients wherethere is evidence of sufficient sound bone to seat and support the components.
Here's a breakdown of the acceptance criteria and study information for the Corin TriFit TS Hip, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Femoral Hip Stem Fatigue (ISO 7206-4: 2010): | All 6 stems passed hip stem fatigue testing for 5 million cycles (mc) at 2.3 kN, meeting the acceptance criteria. |
| Femoral Stem Neck Fatigue (ISO 7206-6: 1992 and ASTM F2068-03): | All 6 stems passed stem neck fatigue for 10 mc at 5.34 kN, meeting the acceptance criteria. |
| Minimum Range of Motion (ISO 21535:2009): | The minimum Range of Motion passed its simulation, meeting the acceptance criteria. |
| CPTi Coating Thickness Testing (Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement): | Tested for porosity, pore size, thickness, surface roughness, mechanical strength (static tensile, static shear, shear fatigue), and taper abrasion. (Implicitly met acceptance criteria as no issues were reported). |
| Calcium Phosphate Coating (BONIT®) Characterization (FDA's "510(k) Information needed for Hydroxyapatite Coated Orthopedic Implants"): | Characterized. (Implicitly met acceptance criteria as no issues were reported). |
| Dual Nonporous Coating Testing (ASTM F1854): | Underwent additional testing to determine thickness, porosity, and pore diameter of the combined coating, as well as bending fatigue testing. (Implicitly met acceptance criteria as no issues were reported). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physical Testing: For both femoral hip stem fatigue and femoral stem neck fatigue, 6 stems were tested. The text does not specify the sample size for the range of motion analysis or the various coating tests, but it indicates these tests were performed on the device or its components.
- Data Provenance: The text does not explicitly state the country of origin for the non-clinical testing. It is implied these tests were conducted as part of the device development and regulatory submission process, likely under controlled laboratory conditions, making them prospective in nature for the purpose of demonstrating device performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This device approval is based on non-clinical testing (mechanical, material, and performance evaluations), not clinical data or expert interpretation of medical images. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical or diagnostic performance is not directly applicable here. The "ground truth" is defined by the established industry standards and test methods (e.g., ISO, ASTM).
4. Adjudication Method for the Test Set
- Not applicable as this is non-clinical performance testing against pre-defined engineering standards, not a diagnostic or clinical efficacy study requiring expert adjudication of results. The results are quantitative measurements against pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not applicable. This document describes the substantial equivalence of a hip prosthesis (a physical medical device), not an AI-assisted diagnostic or triaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is not a software or AI-based device.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests was established by international and national engineering standards and specifications (e.g., ISO 7206-4:2010, ISO 7206-6:1992, ASTM F2068-03, ISO 21535:2009, ASTM F1854) and FDA guidance documents for orthopedic implants and coatings. These standards define the physical properties, mechanical endurance, and other performance characteristics that a hip prosthesis must meet.
8. The Sample Size for the Training Set
- Not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical hip prosthesis, and its evaluation is based on non-clinical engineering tests.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of this device's evaluation.
§ 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.