(205 days)
The Tritanium® Non-Modular Shell & X30 All-Poly Insert are a sterile, single use device intended for use in both primary and revision applications.
Indications:
- Noninflammatory degenerative joint disease incuding osteoarthritis and avascular necrosis:
- Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup);
- Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
The Tritanium Non-Modular Shell is intended for cementless use, while the X30 All-Poly Insert is intended for cemented use only.
The Tritanium Non-Modular Shell described in this Traditional 510(k) submission consist of single use devices which is intended for cementless fixation within the prepared acetabulum. The X3® All-Poly Insert, also single use devices, are intended to mate only with the Tritanium® Non-Modular Shell and must be fixed with bone cement within the metal shell.
The assembled acetabulum component is used in conjunction with any appropriately sized Howmedica Osteonics stem with a compatible head size, excluding bi-polar and uni-polar heads, to that of the respective insert, to achieve total reconstructive replacement of the hip joint.
The provided text is a 510(k) summary for the Tritanium® Non-Modular Shell & X3® All-Poly Insert, which are artificial hip replacement components. It describes the device, its intended use and indications, and states its substantial equivalence to predicate devices.
However, this document does not contain information about the acceptance criteria for a device's performance, nor does it describe any study (including clinical or standalone performance studies) that proves the device meets such criteria.
The 510(k) process for this type of device (hip replacement components) typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish performance metrics like sensitivity, specificity, or reader improvement with AI assistance. Instead, mechanical testing, material characterization, and sometimes animal studies are used to support safety and effectiveness and substantial equivalence.
Therefore, I cannot fulfill the request to provide the acceptance criteria and a study proving the device meets them, as the provided document does not contain this information.
Specifically, the following points cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not applicable/Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present.
- Adjudication method for the test set: Not applicable/Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable/Not present. This device is not an AI/software device that would typically undergo such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not present. This device is a physical implant, not an algorithm.
- The type of ground truth used: Not applicable/Not present.
- The sample size for the training set: Not applicable/Not present.
- How the ground truth for the training set was established: Not applicable/Not present.
§ 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.