Search Results

The PROFEMUR® LX 5/8 Coated Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed

The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

The design features of the PROFEMUR® LX 5/8 Coated Hip Stem are summarized below:

• Manufactured from titanium alloy (Ti6A14V) ●
• Proximal 5/8 of stem plasma sprayed .
• . Offered in Sizes 10-18
• Polished distal tip and collar .
• Threaded hole with slot impaction mechanism .

The provided text describes a 510(k) summary for a medical device, the PROFEMUR® LX 5/8 Coated Hip Stem. However, it does not contain any information regarding specific acceptance criteria, performance studies, or test methodologies typically associated with device performance evaluations, especially for AI/ML-based devices.

This document focuses on:

• Device Identification: Proprietary name, common name, classification, product code.
• Intended Use: Specific conditions for which the hip stem is indicated in total hip arthroplasty (e.g., osteoarthritis, rheumatoid arthritis, revision procedures).
• Device Description: Material (titanium alloy), coating (plasma sprayed), sizes, polished features, and impaction mechanism.
• Substantial Equivalence: A statement that the device is substantially equivalent to previously cleared predicate devices based on identical indications for use, similar design features, and materials. It explicitly states that "The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
• FDA Communication: The FDA's letter confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information in the table format or answer the specific questions (2-9) about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

The document makes no mention of AI, machine learning, or any performance metrics that would require the types of studies outlined in your request (e.g., MRMC studies, standalone algorithm performance). It is a traditional medical device submission for a physical implant.

Ask a specific question about this device