(112 days)
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis o
- Rheumatoid arthritis 0
- o Correction of functional deformity
- O 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, ultra-high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE), vitamin E highly cross-linked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, BIOLOX deltaTM ceramic and CoCr modular heads and titanium femoral stems. The acetabular shells are coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (BonitTM).
The provided text is a 510(k) summary for the Corin Trinity Acetabular System with Trinity-i Acetabular Shells. It describes a medical device, specifically a hip prosthesis, and its substantial equivalence to previously marketed devices.
Based on the information provided in the text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Evidence |
|---|---|---|
| Material Equivalence | The additional components of the Trinity Acetabular System are exactly the same as the predicate devices in terms of materials. | Stated as "exactly the same" as predicate devices (K093472 and K110087). |
| Intended Use Equivalence | The additional components of the Trinity Acetabular System are exactly the same as the predicate devices in terms of intended use. | Stated as "exactly the same" as predicate devices. |
| Indications for Use Equivalence | The additional components of the Trinity Acetabular System are exactly the same as the predicate devices in terms of indications for use. | Stated as "exactly the same" as predicate devices. |
| Design and Performance Equivalence | The additional components are similar in sizes, design, and performance to the predicate devices. | Stated as "similar in sizes, design and performance" to predicate devices. Specifically mentions the Trinity-i Acetabular Shells having a smaller inner diameter with the same outer diameter to accommodate a larger liner/head. |
| Shell Stiffness | Performance related to shell stiffness. | Non-clinical testing conducted, including determination of shell stiffness. Specific acceptance values are not provided in this summary. |
| Coating Process Effect on Shell Taper Form | The coating process does not adversely affect shell taper form. | Non-clinical testing conducted, including the effect of the coating process on shell taper form. Specific acceptance values are not provided. |
| Shell Deformation Effect on Liners | The shell deformation does not adversely affect HXLPE and ECiMa liners. | Non-clinical testing conducted, including the effect of shell deformation on HXLPE and ECiMa liners. Specific acceptance values are not provided. |
| Previous Bench Testing & Characterization | Bench testing for Trinity titanium shells and characterization/testing for the coating should have been completed and found acceptable in previous submissions (K093472 and K110087). | This testing was "included in previous submissions for the Corin Trinity Acetabular System (K093472 and K110087)". Specific acceptance values are not provided here. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Non-clinical testing conducted to demonstrate substantial equivalence includes: determination of shell suffness, effect of the coating process on shell taper form, and the effect of shell deformation on HXLPE and ECiMa liners."
However, no specific sample sizes for these non-clinical tests are provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned in this summary. These are bench tests, so "data provenance" in the sense of clinical patient data would not apply.
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)
This 510(k) pertains to a medical device (hip prosthesis) and its substantial equivalence based on non-clinical bench testing. Therefore, no "ground truth" derived from expert consensus on patient data or clinical scenarios is applicable here. The "truth" is established by engineering specifications and material science standards met during the bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is a non-clinical bench study, no adjudication method involving human readers or experts for a "test set" in a clinical context is relevant or described. The results of the engineering tests would be assessed against pre-defined engineering and material standards.
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
No MRMC comparative effectiveness study was done. This 510(k) is for a hip prosthesis and its substantial equivalence through non-clinical testing. It does not involve AI or human image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a physical hip prosthesis, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this substantial equivalence determination is based on engineering specifications, material properties, and performance standards for the device and its predicate devices, as demonstrated through non-clinical bench testing. There is no clinical "ground truth" from pathology or outcomes data presented in this summary, as clinical testing was not deemed necessary.
8. The sample size for the training set
No training set is applicable or described. This is a physical medical device, and the evaluation is based on non-clinical bench testing and comparison to predicate devices, not on machine learning or AI models that require training data.
9. How the ground truth for the training set was established
As there is no training set, the concept of establishing ground truth for it is 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.