(199 days)
The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total joint replacement.
The XR-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® X-Series femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-620. The stem diameters and lengths are identical. The product offering has been expanded to include reduced proximal profile devices. All devices have a trapezoidal, polished neck.
The provided text is a 510(k) summary for a medical device (XR-Series Bi-Metric® Femoral Components), which is a premarket notification for a Class II medical device. These types of submissions typically outline how a new device is substantially equivalent to existing legally marketed devices, rather than presenting de novo clinical study data to prove novel performance criteria.
Therefore, the document does not contain the kind of information requested in your prompt, which is primarily focused on acceptance criteria, study design, and performance metrics for a device that detects or analyzes data (e.g., an AI-based diagnostic tool).
Here's why the information cannot be extracted from this document:
- Nature of the Device: The device is a "Hip joint replacement device" (femoral component), which is a mechanical implant. It does not generate diagnostic data or rely on algorithms for its function.
- Type of Submission (510(k) Summary): For devices seeking substantial equivalence, the primary focus is on demonstrating that the new device is as safe and effective as a predicate device. This often involves comparing device characteristics, materials, design, and intended use, and may include mechanical testing to ensure engineering integrity. It rarely involves clinical studies with human readers, ground truth establishment, or AI performance metrics.
- Absence of Clinical Testing: The document explicitly states "Clinical Testing: None provided." This confirms that no human-based clinical performance study, as envisioned by your prompt's questions, was conducted or submitted for this specific 510(k).
In summary, none of the requested information regarding acceptance criteria, study design, expert involvement, or AI performance metrics can be provided from this document because it pertains to a mechanical implant device cleared through a substantial equivalence pathway without clinical testing.
§ 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.