(296 days)
The indications for the Corin Trinity™ PLUS Acetabular Shell as a total hip arthroplasty include:
o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
o Rheumatoid arthritis,
o Correction of functional deformity,
o Revision of previously failed total hip arthroplasty
o Developmental dysplasia of the hip (DDH),
The Trinity™ PLUS Acetabular Shell is indicated for cementless use only.
The Trinity™ PLUS Acetabular Shell is a component of a modular cup system consisting of a hemispherical press fit, titanium alloy shell for use with cobalt chrome alloy (Dual Mobility articulations only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip replacement procedures using any Corin femoral stem with a 12/14 taper connection. The acetabular shell has an outer porous structure produced by additive manufacturing using titanium alloy powder (ASTM F3001). The shell is available with or without a layer of electrochemically deposited biomimetic calcium phosphate coating. The Trinity™ PLUS acetabular shell is available with or without screw holes which permit the use of dedicated titanium screws to provide additional fixation if required.
The provided text describes a 510(k) premarket notification for a hip implant device, the Corin Trinity™ PLUS Acetabular Shell. The notification focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria based on a study of its performance in a clinical setting against defined metrics.
Therefore, many of the requested categories (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, how ground truth for training set was established) are not applicable to this type of submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document as this is a 510(k) submission for substantial equivalence, not a clinical trial report with performance metrics. The "acceptance criteria" here are essentially proving the device is as safe and effective as predicate devices. The document details non-clinical testing to demonstrate this.
Non-Clinical Testing Conducted to Demonstrate Substantial Equivalence:
| Test Category | Specific Tests | Result/Conclusion |
|---|---|---|
| Mechanical Tests | Static (Shear, Tensile, Compression) | Performed to show the device is comparable to predicate, within acceptable limits for intended use. |
| Dynamic (Deformation, Bending Fatigue, Shear Fatigue, Range of Motion, Impingement, Shell Fatigue) | Performed to show the device is comparable to predicate, within acceptable limits for intended use. | |
| Material/Structure Characterization | Porous Structure Characterization | Performed to show the device's porous structure is similar to predicate. |
| Biocompatibility | Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology | Conducted on finished, sterilized product, presumably to confirm endotoxin levels are within acceptable limits. |
| Biological Response | Animal Data | Used to support substantial equivalence. (Specifics not detailed) |
Conclusion from Non-Clinical Testing: The culmination of the results of the mechanical testing, characterization, and animal data indicate that the devices perform within their intended use and are substantially equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable for this 510(k) submission, as it relies on non-clinical testing and comparison to predicates, not a clinical test set with human subjects. The non-clinical tests would have their own sample sizes for mechanical specimens, but these are not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not Applicable. Ground truth, in the context of clinical studies, is not established for this type of submission. The "ground truth" for a 510(k) is the performance and safety profile of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. There is no clinical test set requiring adjudication in this 510(k) submission.
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 a medical device for total hip arthroplasty, not an AI-assisted diagnostic or imaging device for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a physical implantable device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not Applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices, which the new device is being compared against.
8. The sample size for the training set:
Not Applicable. There is no "training set" in the context of a clinical study for this 510(k) submission. Non-clinical tests were performed on device samples.
9. How the ground truth for the training set was established:
Not Applicable. As there is no training set, there's no ground truth to establish for it in this context.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.