(168 days)
The Versafit Cup Double Mobility Family is intended for cementless use in total hip arthroplasty and 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. - Dislocation risks
The Versafit Cup Double Mobility Acetabular Component is a two piece modular designed device consisting of the metal acetabular shell and a mating polyethylene liner. The metal component is machined from stainless steel M30NW conforming to ISO 5832-9. The outer surface of the metallic cup has two types of coatings: Ti plasma spray and HA/Ti plasma spray. The polyethylene liner is a double mobility liner made of standard UHMWPE conforming to ISO 5834. The liner has a minimum thickness of 5 mm. The acetabular component is available in 10 sizes which accept both CoCrMo and MectaCer BIOLOX forte Ceramic ball heads with diameters of 22 and 28 mm. The polvethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafit cup Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation. The Versafit Cup Double Mobility Family is designed to be used with the Medacta Total Hip Prosthesis' Quadra S Stems and ball heads (K072857, K073337, K080885, K082792).
The provided text describes the 510(k) summary for the Versafit Cup Double Mobility Family, a medical device for total hip arthroplasty. The document focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested elements about acceptance criteria, study details, human reader performance, sample sizes, and ground truth establishment are not explicitly available in the provided text. The document refers to "performance testing" but does not provide the results of these tests in a quantifiable manner as described in a scientific study.
Here's a breakdown of what can be extracted and what information is missing based on the prompt:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-defined acceptance criteria (specifics not provided) | "The testing met all acceptance criteria" and "verifies that the performance of the Versafit Cup Double Mobility family is substantially equivalent to the predicate devices." (Specific performance metrics are not given.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states testing was "conducted on the worst case component size and option/design," but no number of samples is given.
- Data Provenance: Not specified. The study is described as "Performance Testing" for design verification, implying it's data generated during the development and testing phase by the manufacturer. It does not state if human data was used, but given the device is mechanical, it's likely bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for this type of device (mechanical hip implant) would be based on engineering specifications, material science standards, and established biomechanical performance requirements, not expert clinical interpretation of data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. As this is likely bench testing against predefined engineering specifications, "adjudication" in the sense of reconciling expert opinions on medical imaging or clinical outcomes is not relevant.
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
- MRMC Study: No. This is a medical device (hip implant), not an AI-powered diagnostic tool. Therefore, an MRMC study and effects on human readers are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Based on the context of a 510(k) submission for a mechanical implant, the ground truth would be based on international standards (e.g., ISO 5832-9, ISO 5834) and FDA guidance documents for mechanical and material performance (e.g., strength, wear, biocompatibility). These standards define acceptable material properties and performance characteristics. The document mentions "written protocols with pre-defined acceptance criteria."
8. The sample size for the training set
- Sample Size: Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable for a training set. The "ground truth" for evaluating the device's conformity to standards is established by the specifications in the relevant international standards and FDA guidance documents.
§ 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.