(255 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 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, ceramic and Co-Cr modular heads and titanium femoral stems.
The purpose of this submission is to add ECIMA acetabular liners to the Trinity Acetabular System. Corin's ECIMA is a cold irradiated, mechanically annealed, vitamin E blended ultra high molecular weight polyethylene.
The provided document is a 510(k) summary for the Corin Trinity Acetabular System ECIMA Liners. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical trial or a standalone algorithm performance study.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
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Acceptance Criteria/Device Performance: The document does not describe specific acceptance criteria for performance metrics in a clinical context. Instead, it relies on non-clinical testing to demonstrate performance in various aspects (tensile strength, impact strength, wear, etc.) and states that the new components are "similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance." The implicit acceptance criterion is "substantial equivalence" to the predicate device based on these similarities and the non-clinical test results.
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Study Proving Acceptance Criteria Met: No clinical study is presented to prove the device meets acceptance criteria.
Let's address the specific points you asked for, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Efficacy/Safety | Not specified (no clinical study performed) | Not reported (no clinical study performed) |
| Material/Mechanical Properties | Implied to be similar to predicate device (K110087) based on non-clinical testing. | Non-clinical tests were performed for: tensile strength, impact strength, compressive strength, small punch strength, thermal properties, free radical concentration, oxidation resistance, swell ratio, hip simulator wear (normal and abrasive conditions), wear particle characterization, rim impingement, liner push-out, torque-out resistance, GCMS analysis of hexane and IPA extracts, consolidation assessment, fatigue crack propagation, trans-vinylene index, cyclic loading with accelerated ageing, and biocompatibility (genotoxicity, acute systemic toxicity, irritation, sensitization, cytotoxicity, implantation). |
| The document states: "The additional components of the Trinity Acetabular System are similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance. Based on these similarities, the additional components of the Trinity Acetabular System are believed to be substantially equivalent to the predicate devices." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes but these are not disclosed in the summary.
- Data Provenance: Not applicable. No clinical data is presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. No clinical test set or ground truth established by experts.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. No clinical study, and no human-in-the-loop AI component discussed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
- For the non-clinical tests, the ground truth would be the objectively measured values of the material and mechanical properties. For the purpose of the 510(k), the "ground truth" for substantial equivalence is the predicate device's characteristics and performance, against which the new device's non-clinical test results are compared.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical implant, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.