(71 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 crosslinked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique and 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 ttanium 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 Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell and the Trinity-i Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell. Both of these variants, subject of this submission, are coated with a rough titanium plasma spray, contain non-threaded holes for the use of titanium screw fixation and do not come pre-assembled with the hole occluders in place.
This document describes the premarket notification (510(k)) for the Corin Trinity Non-occluded Titanium Plasma Sprayed (TPS) Acetabular Shells. It clarifies that no clinical testing was deemed necessary to demonstrate substantial equivalence, and therefore, the concept of "acceptance criteria" as applied to device performance in a clinical study isn't directly applicable for this submission.
Instead, the submission relies on non-clinical testing to show that the new variants are substantially equivalent to previously cleared predicate devices. Substantial equivalence for this medical device (hip prosthesis components) is established by demonstrating that the new devices have the same intended use, indications for use, substrate materials, and similar design and coating characteristics as the predicate devices, and that non-clinical testing supports their safety and effectiveness.
Here's an analysis based on the provided document, addressing the specific points where information is available or noting its absence:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence based on non-clinical testing, explicit "acceptance criteria" and "device performance" in terms of clinical outcomes are not defined in the provided text. The "performance" is demonstrated through substantial equivalence to predicate devices and non-clinical bench testing.
| Acceptance Criterion (Implicit) | Reported "Device Performance" |
|---|---|
| Intended Use: (Same as predicate devices) | The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of intended use. |
| The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of intended use. | |
| Indications for Use: (Same as predicate devices) | The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of indications for use. |
| The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of indications for use. | |
| Substrate Materials: (Same as predicate devices) | The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of substrate materials. |
| The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of substrate materials. | |
| Size Range: (Same as predicate devices) | The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of size range. |
| The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of size range. | |
| Design Similarity: (Similar to predicate devices, specifically regarding non-threaded holes for screw fixation and rough TPS coating) | The standard Trinity Non-occluded TPS and the Trinity-i Non-occluded TPS shells are similar in design to the Corin predicates with non-threaded holes for the use of titanium screw fixation and a rough titanium plasma spray coating only. |
| Coating Characteristics: (Similar/identical to predicate devices) | The titanium plasma spray coating of the non-occluded TPS variants is similar to the titanium plasma spray coating of the United U2 Acetabular Component (K050262) and identical to the titanium plasma spray coating applied to predicates K093472, K110087, and K122305. |
| Non-Clinical Test Results: (Demonstrate safety and effectiveness, supporting substantial equivalence) | "Non-clinical testing conducted to demonstrate substantial equivalence includes: screw range of motion and bench testing of the Trinity titanium shells and characterization and testing for the coating... The results of this testing show that the Trinity and Trinity-i non-occluded TPS variants are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices." (Specific numeric acceptance criteria for these tests are not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific non-clinical tests in this 510(k) summary. These would typically be detailed in the full non-clinical test reports submitted to the FDA, but not in the summary.
- Data Provenance: Not applicable in the context of an AI device's test set for a clinical study, as this submission is for a medical implant and relies on non-clinical (bench) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No clinical test set or human expert review for establishing ground truth was used for this submission. The "ground truth" for substantial equivalence is derived from the characteristics of the predicate devices and the results of non-clinical engineering and material tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
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 is not an AI device or a diagnostic imaging device requiring human reader assessment. It is a hip prosthesis component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established safety and effectiveness of the predicate devices, as demonstrated through their own prior clearances (K093472, K110087, K122305, K050262) and the engineering and material science principles applied in the non-clinical testing. It's essentially equivalence to known performance of existing devices.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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.