(154 days)
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- Previously failed hip surgery.
- Fractures of the femoral neck or head.
- Avascular necrosis of the femoral head.
- Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to prosthesis.
The proposed subject device is a line extension to the acetabular cup system previously cleared in K103384. The predicate is a modular system intended for the replacement of the natural articular surface of the hip joint in total hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.
The subject and predicate acetabular liners are both made of highly cross-linked polyethylene and are hemispherical in shape with positive locking, liner stabilization, and anti-rotation features.
The Legend Acetabular Liners (subject device) differ from the predicate device, cleared in K103384, through the addition of new sizes. Other components of the system have not been modified and are not a part of this submission other than by reference.
This document is a 510(k) premarket notification for the Legend® Acetabular Liners. It is a submission for a medical device and, as such, does not involve studies related to AI, image interpretation, or human-in-the-loop performance. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing of a physical medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Impingement Performance per ASTM F-2582 | Met predetermined acceptance criteria. |
| Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011 | Met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the non-clinical tests (impingement performance and bacterial endotoxin testing). It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective, though for non-clinical lab testing of a physical device, these provenance details are less commonly reported in summary documents.
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" in this context refers to the performance standards set by ASTM and ANSI/AAMI for the physical properties of the device, not expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a physical device performance test, not an interpretive one requiring adjudication.
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
No. This is a medical device, specifically an orthopedic implant, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by the specified industry standards and methodologies: ASTM F-2582 for Impingement Performance and ANSI/AAMI ST72:2011 for Bacterial Endotoxin Testing. These are objective engineering and microbiological performance standards.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
§ 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.