(336 days)
The Meridian™ ST Femoral Stem and Vitalock® Solid Back Acetabular Shell with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum damaged as a result of non-inflammatory joint disease, avascular necrosis or trauma.
The Meridian® ST Femoral Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum damaged as a result of non-inflammatory joint disease, avascular necrosis or trauma. These devices are identical to the Meridian® ST femoral stem and Vitalock® Solid Back shell previously released under K94507, K930223, and K952397 respectively, except for a thin layer of hydroxyapatite coating applied to the porous coated surface.
The provided text describes a 510(k) premarket notification for the Meridian® ST Femoral Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating. This document focuses on establishing substantial equivalence to previously marketed devices rather than presenting detailed performance studies with acceptance criteria in the way one might find for a new diagnostic or AI-powered device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not available in the provided text. The submission primarily relies on comparing the new device's intended use, materials, design, and operational principles to existing predicate devices.
Here's what the document does state about the assessment:
- Equivalence Basis: "This equivalence is based upon similarities in intended use, material, design, and operational principles to the legally marketed devices."
- Specific Testing Mentioned: "Testing to characterize the Peri-Apatite™ coating was presented, along with the results of an animal study."
- FDA's Determination and Limitations: The FDA's letter states, "The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." It explicitly prohibits claims for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." This indicates that while some testing was done (coating characterization, animal study), it was not sufficient to support efficacy claims beyond mechanical interlock, thus not meeting higher 'acceptance criteria' for biological performance.
Conclusion:
The provided text does not contain the specific information required to complete the table and answer the questions regarding acceptance criteria, study design, sample sizes, ground truth, experts, or MRMC studies. The 510(k) submission process outlined here is for demonstrating substantial equivalence based on fundamental device characteristics and existing predicate claims, not necessarily for proving novel performance metrics against pre-defined acceptance criteria in the manner an AI or diagnostic device would.
§ 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.