(134 days)
The OMEGA® II Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Not Found
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for the OMEGA® II Modular Total Hip System.
This type of letter grants clearance for a device based on its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria or the details of a study proving the device meets those criteria. The letter refers to the "indications for use" and mentions general controls and regulations but doesn't elaborate on performance testing or clinical studies for this particular submission.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and reported device performance: This information is not present.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- MRMC comparative effectiveness study details: Not mentioned.
- Standalone algorithm performance: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.