(28 days)
The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or
psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis.
· Avascular necrosis of the femoral head.
· Acute traumatic fracture of the femoral head or neck.
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Versafitcup CC Trio family of acetabular components is designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, K083558, and K112115). The AMIStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944, K103189). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Versafitcup CC Trio extension that are the subject of this 510(k) consist of new sizes of flat and hooded liners, new sizes of the two-hole acetabular shell, and no-hole acetabular shells. The liners are made from either ultra-high molecular weight polyethylene (UHMWPE) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE) conforming to ISO 5834. The acetabular shells are made from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3. The outside of the metal component has macrostructures in the equatorial region. The outer surface of the metallic cup has a dual laver of coatings: Ti (ASTM F 1580) plasma spray and Hydroxyapatite (ASTM F 1185).
All the Versafitcup CC Trio extension components are supplied sterile in single-use individual packages.
The provided text describes a 510(k) premarket notification for a medical device, the Versafitcup CC Trio extension, which is an acetabular component for total hip arthroplasty. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with acceptance criteria in the typical sense of a diagnostic or AI device.
Therefore, the information requested for AI/diagnostic devices, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is not applicable or available in this document.
Instead, the performance testing described is focused on mechanical characteristics, comparing the new device components to "worst case liners and acetabular shells of the predicate devices."
Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Range of Motion | Compared to predicate, found to be acceptable. |
| Instability of connection between liner and acetabular shell | Compared to predicate, found to be acceptable. |
| Wear | Compared to predicate, found to be acceptable. |
| Safety & Effectiveness | "does not introduce any new issues in regards to safety and effectiveness." |
Note: The document does not provide specific numerical acceptance criteria or performance metrics (e.g., maximum allowable wear per year, specific range of motion values). The acceptance is implicitly based on being comparable to or not worse than the predicate devices' "worst case" performance for these mechanical tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The testing is described as mechanical testing of the device components, not involving human subjects or clinical data in the form of a test set.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing is laboratory-based mechanical 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. The "ground truth" here is based on engineering specifications and mechanical test results, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of expert opinions for clinical ground truth.
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 type of study is for diagnostic or AI-assisted interpretation, which is outside the scope of this device's submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implanted medical device, not a diagnostic algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" or basis for evaluation is compliance with mechanical testing standards and comparison to the performance of predicate devices for parameters like range of motion, connection stability, and wear. These are engineering and material science metrics.
8. The sample size for the training set
- Not applicable. This refers to training data for an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This refers to establishing ground truth for AI training data.
§ 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.