(119 days)
The DURASUL acetabular insert is a snap-in acetabular shell liner that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The insert is available in three styles and is intended to be used in conjunction with an Inter-Op acetabular shell to replace the acetabulum during total hip arthroplasty. Inter-Op acetabular components (shell/insert combination) may be implanted with or without bone cement.
Diagnostic indications for use of this device include:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of previously failed hip arthroplasty. ●
Sulzer Orthopedics currently markets a polyethylene shell liner (insert) in conjunction with its Inter-Op Acetabular System. The UHMWPE insert was originally cleared via 510(k) K955033 and is available in three styles, all of which mate with various shell designs in the system.
The purpose of this submission is to describe a different UHMWPE treatment process that was developed and patented by Massachusetts General Hospital (MGH) and Massachusetts Institute of Technology (MIT). This treatment produces a highly cross-linked polyethylene and reduces free radicals that can lead to oxidative degradation. This in turn provides a highly wear resistant surface which has been demonstrated through hip simulation.
Sulzer Orthopedics has licensed this process for use in the manufacture of Inter-Op acetabular inserts. Sulzer Orthopedics does not intend to change the intended use of this device, nor do we intend to alter the basic geometrical design of the three insert styles. Moreover, while there is a change in process to enhance the wear properties of UHMWPE, there is no change to the raw material (GUR 1150/1050 conforming to ASTM F 648).
The provided text describes a medical device, the Sulzer Orthopedics Inter-Op™ DURASUL™ Acetabular Insert, and its clearance process. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity).
The submission is for a 510(k) premarket notification for a Class II medical device, which is a hip joint prosthetic component. The "study" mentioned is an in vitro wear test, not a diagnostic study with human subjects, and the acceptance criteria are related to mechanical performance rather than diagnostic accuracy.
Therefore, many of the requested fields cannot be filled as they pertain to diagnostic device studies.
Here's a breakdown of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance (DURASUL™) | Comparator (Control) Performance |
|---|---|---|---|
| Wear Properties (Hip Simulation) | Reduced wear compared to existing inserts | Undetectable wear over 5 million cycles | Steady average wear rate of approximately 12 mg/million cycles |
| Mechanical Properties | Not compromising fatigue and creep behavior | Fatigue and creep behavior essentially same as standard material | Fatigue and creep behavior of standard material |
| Locking Strength | Not compromising shell/liner interface locking strength | Locking strength same as currently available device | Locking strength of currently available device |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable for a diagnostic performance study. The wear test refers to "DURASUL inserts" and "CONTROL inserts," implying multiple samples were tested, but specific numbers are not provided.
- Data Provenance: In vitro hip simulator test. Countries of origin for data or retrospective/prospective nature are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is an in vitro mechanical performance study, not a diagnostic study requiring expert ground truth.
4. Adjudication method for the test set:
- Not applicable as this is an in vitro mechanical performance study.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance evaluation was focused on the material properties of the insert itself in a simulated environment.
7. The type of ground truth used:
- Mechanical/Physical Measurements: The "ground truth" for the wear study was the direct measurement of material loss (wear) over a specified number of cycles in a hip simulator. For fatigue, creep, and locking strength, it was based on standard mechanical testing protocols and measurements.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning model.
Summary of Device and Study Focus:
The provided document describes the modification of an existing acetabular insert (a component of a total hip replacement) to improve its wear characteristics. The "study" mentioned is an in vitro hip simulation wear test comparing the new DURASUL™ insert to the previous version (CONTROL). The success criteria revolve around the mechanical performance and material properties of the UHMWPE, specifically its wear resistance, fatigue, creep behavior, and locking strength. There is no diagnostic component to this device or its evaluation as described.
§ 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.