(382 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) and 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 (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset and 10° hooded designs) and a dedicated range of 28mm and 32mm zirconia and cast cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic or metal on UHMWPE articulation for use in total hip replacement procedures using Corin Tri-fit femoral stems with a 12/14 taper connection. The UHMWPE is previously cleared. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole. 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.
This document is a 510(k) summary for the Trinity Acetabular System Hip Prosthesis. It does not describe an AI medical device or a study proving its performance against specific acceptance criteria in the way you've outlined for AI/software-based devices.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary pathway for 510(k) clearances. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices.
Therefore, I cannot populate the requested table and answer the questions related to AI/software performance studies as this is a traditional orthopedic implant device submission.
Here's a breakdown of why the requested information isn't present in the document provided:
- Type of Device: The Trinity Acetabular System is a physical medical device (a hip prosthesis), not an AI/software-as-a-medical-device (SaMD).
- Regulatory Pathway: It's a 510(k) premarket notification for a Class II device. This pathway relies heavily on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance acceptance criteria through clinical trials for novel technology.
- "Study" type: The "study" described is entirely non-clinical (bench testing and coating characterization), not a clinical trial or performance study against a ground truth.
Key takeaways from the document that relate to its "acceptance":
- Substantial Equivalence: The primary "acceptance criteria" is that the device is "substantially equivalent" to legally marketed predicate devices. This means it performs at least as safely and effectively as those predicates.
- Non-Clinical Testing: A range of bench tests were performed to support substantial equivalence, including:
- Retention mechanism testing (push-out, lever-out, torque-out)
- Range of motion analysis
- Bone screw testing (torque-out, pull-out, range of motion)
- Oxidative index testing (for UHMWPE)
- Impingement testing (for UHMWPE)
- Wear testing (for UHMWPE)
- Coating characterization: porosity, pore size, surface roughness, mechanical strength (static tensile, static shear, shear fatigue), taper abrasion for CPTi coating.
- Calcium phosphate coating characterization as per FDA guidance.
- Shell stiffness, shell occluder locking strength, fretting/corrosion testing, and pull-off testing of the femoral head.
- No Clinical Testing: The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the Trinity Acetabular System and the predicate devices."
In summary, the provided text describes a traditional orthopedic device's regulatory submission, not an AI or software device. The acceptance is based on substantial equivalence demonstrated through non-clinical bench testing, not an AI performance study with ground truth.
§ 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.