(30 days)
The EMPHASYS Acetabular System is indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
EMPHASYS Acetabular Cups are indicated for cementless use only.
The subject devices in this line extension to the EMPHASYS Acetabular System (previously cleared through Primary Predicate 510(k) K221636) include three additional porous-coated titanium alloy Acetabular Shells in a multi-hole configuration and ten corresponding AOX polyethylene Acetabular Liners in three configurations (Neutral, +4 Neutral and ELV)
This is a medical device submission, not a software or AI device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable in the context of this document. This document pertains to the clearance of an acetabular system for total hip replacement, which involves physical device testing and comparison to predicate devices, not algorithmic performance.
Here's why each point is not applicable:
- A table of acceptance criteria and the reported device performance: This usually applies to diagnostic or AI algorithms where performance metrics like sensitivity, specificity, AUC are relevant. For a physical orthopedic implant, performance is assessed through mechanical and material testing against established standards, not necessarily a concise table of "acceptance criteria" as would be seen for software. The document states that testing was done for "Interconnection strength of shell and liner per ASTM F1820-22," implying adherence to a standard, but does not provide specific acceptance values or results in this summary.
- Sample sized used for the test set and the data provenance: Not applicable for a physical implant. "Test set" in an AI/software context refers to data. Here, it refers to physical units of the device tested in a lab.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is generally for classification/detection tasks. For an implant, "ground truth" would be the physical properties confirmed through engineering tests.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in expert reviews of data/images.
- 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 for AI-assisted diagnostic tools, not an orthopedic implant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its material properties and mechanical performance confirmed by standardized testing, not expert consensus on medical images or pathology.
- The sample size for the training set: Not applicable. This is for AI/machine learning models.
- How the ground truth for the training set was established: Not applicable. This is for AI/machine learning models.
Summary of Relevant Information (from the document) for a Physical Device:
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Performance Testing: The EMPHASYS Acetabular System subject devices were compared to predicate devices. Testing and analyses included:
- Interconnection strength of shell and liner per ASTM F1820-22.
- No new worst-case was identified for: Range of motion, Deformation, Impingement, Unsupported Shell Fatigue, Analysis of shell and liner thickness, Articular clearance, Wear Friction, MRI Safety.
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Substantial Equivalence: The device is substantially equivalent to identified predicates with respect to intended use, indications, materials, geometry, range of sizes, and method of fixation. Performance testing and analyses demonstrate that it performs as well as the predicate devices.
§ 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.