(21 days)
The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatoid . arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
The existing Trident® Polyethylene Acetabular System features acetabular liners in neutral, hooded, eccentric and elevated rim versions. The subject Trident® Crossfire® Polyethylene Liners are an addition to the existing liners (standard and eccentric versions). The subject liners will be offered in fourteen new sizes which include the addition of a 36mm size eccentric liner in both 0° and 10° versions and 26mm, 28mm, 32mm and 36mm size standard liners in both 0° and 10° versions in the same polyethylene thicknesses as the Trident® Elevated Rim Liners. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.
The provided text does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria in terms of analytical or clinical performance.
Instead, the document is a Special 510(k) Premarket Notification for a line extension to an existing acetabular system. The purpose of this type of submission is to demonstrate that a modified device is substantially equivalent to a legally marketed predicate device, not to establish performance against specific acceptance criteria for a new device.
The "Testing Summary" section mentions:
- Engineering analysis was used to ensure the risk of cam-out for the subject device is less than the risk associated with predicate devices.
- Hip wear simulator testing of a similar cup liner was used to demonstrate comparable safety and effectiveness of the new liner sizes to the predicate devices.
However, it does not provide:
- Specific acceptance criteria (e.g., maximum allowable wear rate, specific cam-out force thresholds).
- Detailed results from these tests or how they "prove" meeting acceptance criteria.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone studies, or details about training sets/ground truth for machine learning algorithms. This is because the device (acetabular liners for hip replacement) is a physical medical implant, not an AI/ML-driven diagnostic or analytical device.
Therefore, I cannot provide the requested table and information, as the input document describes a mechanical device submission, not an AI/ML device submission that would typically involve such performance metrics and study designs.
§ 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.