(50 days)
The Trinity Acetabular System is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
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 indicated for cementless, single use only.
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell with, ultra high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE) and vitamin E highly cross-linked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW. The Trinity system also includes, BIOLOX delta™ ceramic and CoCr modular heads which are intended for use with Corin titanium femoral stems. The acetabular shell comes in two variants, a standard Trinity (K093472 and K110087) and a Trinity-i (K122305) shell, both coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (BONIT™). The Trinity and Trinity-i acetabular shells are provided with screw holes and come assembled with titanium occluders in place. Dedicated titanium screws are also provided for additional fixation if required.
The purpose of this submission is to add two more acetabular shell variants to the Trinity Acetabular System, the standard Trinity No Hole acetabular shell and the Trinityi No Hole acetabular shell. Both of these variants, subject of this submission, are similar to the standard Trinity Acetabular shells previously cleared (K093472, K110087 and K122305) with the only difference being the shells subject of this submission do not have screw holes in them.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Corin Trinity Acetabular System (K130128):
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
No explicit acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision) or a standalone performance study of the device's diagnostic or therapeutic efficacy are presented in this 510(k) summary.
Instead, the acceptance criteria are met through demonstrating:
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Similarity in: | The Trinity No Hole acetabular shells are identical to the predicate Trinity Acetabular Shell cleared in K093472 and K110087 in terms of: |
| Intended Use | Identical |
| Indications for Use | Identical |
| Substrate Materials | Identical |
| Size Range | Identical |
| Design | Similar (The only difference is the absence of screw holes) |
| Performance | Similar |
| Similarity in: | The Trinity-i No Hole acetabular shells are identical to the predicate Trinity-i Acetabular Shell cleared in K122305 in terms of: |
| Intended Use | Identical |
| Indications for Use | Identical |
| Substrate Materials | Identical |
| Size Range | Identical |
| Design | Similar (The only difference is the absence of screw holes) |
| Performance | Similar |
| Similarity to DePuy Pinnacle 100 Acetabular Shell (K001534): | The intended use, indications for use, substrate material, size range, and design of the Trinity No Hole shells are similar. |
The study underpinning this submission focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a standalone clinical performance study verifying new performance metrics for the modified device.
2. Sample Size Used for the Test Set and Data Provenance:
No specific "test set" in the context of clinical trials or data analysis is mentioned because this submission relies on demonstrating substantial equivalence to previously cleared devices. The testing conducted was "non-clinical testing" including comparisons of designs, materials, intended use, indications, and dimensions. Therefore, there is no sample size for a test set or data provenance from a patient population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. As described above, there was no clinical test set or ground truth established by experts in the context of diagnosing or categorizing patient data.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical test set or adjudication process for diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC study was not performed. The submission relies on establishing substantial equivalence through non-clinical testing and comparison to predicate devices, not on proving improved human reader performance with AI assistance. The device in question is a physical medical device (hip prosthesis components), not an AI-powered diagnostic tool.
7. Type of Ground Truth Used:
For the purpose of this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness of the predicate devices (Corin Trinity Acetabular System K093472, K110087, K122305, and DePuy Pinnacle 100 Acetabular Shell K001534). The current device's "no hole" variants are considered substantially equivalent if they match the predicates in key aspects.
8. Sample Size for the Training Set:
Not applicable. This device is a modified physical implant, not an algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As stated above, there is no training set for an algorithm.
§ 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.