(29 days)
The ADVANCE® Revision Product Line Extension components are indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
These products are for use with cement only.
The ADVANCE® Revision Product Line Extension components consists of femoral and femoral augments, and tibial inserts intended to be used only with bone cement.
The provided text describes a medical device, the ADVANCE® Revision Product Line Extension, which is a total knee revision replacement implant. However, the document is a 510(k) summary and FDA approval letter. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria, as is typically found in a clinical study report or a more detailed technical submission.
The "Testing Summary" section only states: "Testing meets the requirements cited in the FDA Guidance Documents." This is a general statement and does not provide specific acceptance criteria or details of actual performance.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.
The available information is limited to:
- Device Name: ADVANCE® Revision Product Line Extension
- Common Name: Total Knee Revision Replacement Implant
- Indications for Use: Total knee replacements for noninflammatory degenerative joint disease, inflammatory degenerative joint disease, correction of functional deformity, revision procedures, and treatment of unmanageable fractures.
- Materials: Cobalt chrome alloy (femoral component), ultra high molecular weight polyethylene (tibial components), titanium (femoral augments).
- Limitations: Intended for cemented use only.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.