(99 days)
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is to be used for uncemented applications.
This Traditional 510(k) is a line extension to the X-alt Highly Cross Linked Acetabular Liner with Vitamin E product line to expand femoral head compatibility within the system by making larger femoral heads compatible with smaller acetabular cups.
The provided text describes a medical device called "FMP Extended Liners" for hip joint replacement. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.
Here's why and what information is missing:
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Acceptance Criteria and Device Performance (Question 1): The document states "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices" after listing non-clinical tests (wear, impingement, push-out, lever-out, torsion, range of motion). This indicates that the device met the performance standards demonstrated by the predicate devices. However, the specific acceptance criteria (e.g., "wear not to exceed X mm^3/million cycles") and the reported device performance values for each test are not provided.
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Sample Size, Ground Truth, Adjudication, MRMC, Standalone, Training Set (Questions 2-9): The document explicitly states: "Clinical Testing: Clinical testing is not required." This means that no human-based studies (like those involving test sets, ground truth establishment, expert adjudication, or MRMC studies) were conducted or reported for this submission. The tests performed were non-clinical (mechanical and material tests). Similarly, there is no mention of a training set or how ground truth for a training set would be established, as algorithm-only performance (standalone) studies typically apply to software or AI/ML devices, not mechanical implants.
In summary, based on the provided text, I cannot answer questions 1-9 comprehensively because the submission focuses on demonstrating substantial equivalence through non-clinical laboratory testing, rather than clinical trials or AI/ML performance studies with specific acceptance criteria and performance metrics for such studies.
The information available is:
- Device Name: FMPT™ Extended Liners
- Tests Performed: Wear per ISO 14242-2/3, impingement per ASTM F2582-14, push-out, lever-out, torsion per ASTM F1820-13, and range of motion per ISO 21535:2009.
- Conclusion of Tests: "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices."
- Clinical Testing: Not required.
§ 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.