(106 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 allov shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems.
The purpose of this submission is to add 32mm (+7mm offset), 36mm (+8mm offset), and 40mm (+8mm offset) CoCrMo and BIOLOX delta™ ceramic extralong femoral heads to the Trinity Acetabular System.
This document describes a 510(k) submission for the Corin Trinity Acetabular System with Extra Long Heads. It is a modification to an existing hip prosthesis system. The key takeaway is that no clinical studies were conducted to demonstrate the device meets acceptance criteria. Instead, it relies on non-clinical testing and substantial equivalence to predicate devices. Therefore, many of the requested fields regarding clinical study details cannot be populated.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical Testing: | Non-clinical Testing: |
| Stem fatigue testing | Performed (results not detailed, but considered sufficient to demonstrate substantial equivalence) |
| Neck fatigue testing with worse-case head offsets | Performed (results not detailed, but considered sufficient to demonstrate substantial equivalence) |
| Clinical Testing: | Clinical Testing: |
| Not applicable (no clinical testing performed) | Not applicable |
2. Sample size used for the test set and the data provenance
- Not Applicable: No clinical test set was used. Non-clinical testing (fatigue testing) typically involves a small number of samples (e.g., 6-12 samples per condition) tested under specified load conditions, but the exact sample sizes are not provided in this summary. The data provenance would be from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: Given that no clinical studies were performed and the device relies on non-clinical testing and substantial equivalence, there was no "ground truth" established by experts in the context of a clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set and thus no adjudication method for ground truth determination.
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 device is a hip implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a physical medical device (hip prosthesis), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: For the non-clinical testing, the "ground truth" would be the engineering specifications and performance standards for fatigue resistance. For the regulatory submission, the "ground truth" is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not Applicable: No training set was used as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable: No training set was used.
§ 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.