(226 days)
The Versafitcup™ 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 Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are a modification of the polyethylene liners to be made of a highly crosslinked ultra high molecular weight polyethylene. The liners are identical in sizes, dimensions and functionality as the standard UHMWPE liners which were cleared as part of the original 510(k) submission. The Highcross® UHMWPE liners are manufactured from UHMWPE that has been crosslinked by controlled exposure to radiation followed by a stabilizing heat treatment prior to machining of the liners. The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to wear. The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648. There is no change to the metal acetabular cup of the Versafitcup™ Double Mobility system. The polyethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafitcup™ Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation. The Versafitcup™ Double Mobility Family including the new highly crosslinked UHMWPE liners are designed to be used with the Medacta Total Hip Prosthesis' Quadra Stems and ball heads (K072857, K073337, K080885, K082792).
This document describes the premarket notification (510(k)) for the Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners, a hip joint prosthesis component. The focus of the submission is on demonstrating substantial equivalence to a predicate device, which is primarily achieved through performance testing and comparison of material properties and design.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table detailing "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might expect for software or diagnostic devices. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with various international standards and FDA guidance documents. | Testing results met all pre-defined acceptance criteria. |
| Physical and mechanical properties similar to standard UHMWPE. | "The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE..." |
| Increased resistance to wear compared to standard UHMWPE. | "...has increased resistance to wear as shown in simulator wear data" |
| Substantial equivalence to predicate device (K083116) in intended use, raw material, manufacturing method, design, sizes, dimensions, mating components, sterilization, and packaging. | The submission asserts and FDA concurs that the device is substantially equivalent to the predicate device in these aspects. |
| Compliance with ASTM F648 for highly crosslinked UHMWPE. | "The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "testing was conducted on the worst case component size and option/design." No specific numerical sample size is provided for the performance testing.
- Data Provenance: The data is generated from in vitro performance testing (e.g., "simulator wear data") conducted by the manufacturer, Medacta International SA. It is not patient or clinical data. The country of origin of the data would be where Medacta International SA performed the testing, which is Switzerland. The data is retrospective in the sense that it describes the performance of the manufactured product under test conditions, not prospective clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This criterion is not applicable in the traditional sense for this type of device and submission. The "ground truth" for the device's performance is established through objective engineering and material science testing against predefined standards and specifications, not through expert consensus on medical images or diagnoses. There's no mention of experts establishing ground truth for the test set.
4. Adjudication Method for the Test Set
This criterion is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases (e.g., radiology reads) to establish a consensus ground truth. The performance testing for this orthopedic implant relies on objective measurements from instruments and protocols.
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
This criterion is not applicable. The device is an orthopedic implant (hip liner), not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or assessment of AI assistance improvement for human readers was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This criterion is not applicable. The device itself is a physical medical device. There is no "algorithm" to be tested in a standalone manner without human-in-the-loop performance. The testing performed is on the physical properties and wear characteristics of the implant material.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the device's performance is based on:
- Material Specifications and Standards: Compliance with ASTM F648 for highly crosslinked UHMWPE.
- Engineering Performance Benchmarks: Comparison of physical and mechanical properties to standard UHMWPE and demonstration of increased wear resistance through simulator testing.
- Design and Manufacturing Consistency: Ensuring the new liners maintain the same design, sizes, dimensions, functionality, and manufacturing methods as the predicate device.
8. The Sample Size for the Training Set
This criterion is not applicable. There is no "training set" in the context of an AI/machine learning model. The device is a physical product, and its development and validation rely on engineering design, material science, and physical testing.
9. How the Ground Truth for the Training Set Was Established
This criterion is not applicable as there is no training set for an AI/machine learning model.
In summary: The provided document describes the regulatory submission for a physical medical device (hip joint liner). The performance testing and acceptance criteria are rooted in material science, engineering standards, and direct comparison to a predicate device's established characteristics, rather than clinical efficacy studies, expert consensus on images, or AI algorithm validation methods.
§ 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.