(114 days)
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Trinity Acetabular System is intended for cementless, single use only.
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and BIOL.OX delta™ ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin utanium femoral stems.
The purpose of this submission is to add 28mm (-5mm offset), 32mm (-6mm offset), 36mm (-8mm offset), and 40mm (-8mm offset) CoCrMo extra short femoral heads to the Trinity Acetabular System, and complete the line of extra long heads with the addition of a 28mm (+7mm offset) CoCrMo heads.
This document describes the Corin Trinity Acetabular System with Extra short Heads and 28mm Extra long Head (K131647).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain explicit acceptance criteria in the traditional sense of performance metrics with specific thresholds (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices for new components being added to an existing system.
The "performance" demonstrated for these new components is primarily through non-clinical testing.
| Acceptance Criteria Category | Specific Criteria (Implicit from Substantial Equivalence Logic) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|---|
| Intended Use & Indications | Must be identical to or covered by predicate devices. | Identical to predicate devices (K093472, K110087, K130343) and similar to predicate devices (K993438, K003363, K042037). |
| Material Composition | Must be identical to predicate devices. | Identical to predicate devices (K093472, K110087, K130343, K993438, K003363, K042037). |
| Design & Sizes | Must be similar to predicate devices, ensuring compatibility and functionality within the existing system. | Similar to predicate devices in sizes and designs. |
| Performance (Mechanical) | Must demonstrate safe and effective mechanical performance, particularly regarding range of motion and fatigue, especially in worst-case scenarios. | Non-clinical testing conducted: impingement testing, range of motion testing, stem fatigue testing and stem neck fatigue testing with head offsets representing the worse-case scenario for compatible stems. |
2. Sample Size Used for the Test Set and Data Provenance
This submission pertains to the addition of new components (extra short and extra long femoral heads) to an existing hip prosthesis system. The evaluation relies on non-clinical testing (mechanical tests) rather than human clinical data. Therefore, the concepts of "test set" and "data provenance" as typically applied to AI/software performance studies are not directly applicable here. The "sample size" would refer to the number of physical components tested in the lab, but this detail is not provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a medical device (hip prosthesis components) and the evaluation relies on non-clinical mechanical testing, there is no "ground truth" established by human experts in the context of diagnostic or interpretive performance. The "ground truth" for mechanical testing would be derived from engineering standards and test protocols.
4. Adjudication Method for the Test Set
Not applicable. Since the evaluation is based on non-clinical mechanical testing, an adjudication method for human interpretation is not relevant.
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. This submission is for physical medical device components, not an AI or software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for physical medical device components, not an AI or software algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be established by engineering specifications, established test methods, and industry standards for mechanical performance of hip prosthesis components. For example, fatigue tests would have pre-defined failure criteria based on regulatory guidance or consensus standards.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this type of physical medical device submission, as it does not involve machine learning or data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved.
§ 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.