(29 days)
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:
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- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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- inflammatory degenerative joint disease such as rheumatoid arthritis;
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- correction of functional deformity; and,
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- 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.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.