(160 days)
The Preserve Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity: and.
- revision procedures where other treatments or devices have failed
The Preserve hip stem is intended for cementless hip arthroplasty.
The Preserve stems are short modular hip stems that couple with modular necks. Design features of the stems are summarized below:
- . Cementless stem with proximal cpTi plasma spray coating
- Available in 9 sizes (4-12)
- Manufactured from Ti alloy
The Preserve Hip Stems were evaluated via mechanical testing; including fatigue, fretting; and distraction evaluation. A review of these results indicates that the Preserve Hip Stems are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
Based on the provided text, the document is a 510(k) Summary of Safety and Effectiveness for the PROFEMUR® Preserve Hip Stems, a medical device used in hip replacement surgery. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device.
The document focuses on demonstrating substantial equivalence to predicate devices through:
- Device Description: Material, size, and design features.
- Intended Use and Indications for Use: Identical to previously cleared predicate devices.
- Technological Characteristics: Similar to predicate devices.
- Nonclinical Testing: Mechanical testing (fatigue, fretting, distraction evaluation) per ISO standards.
- Clinical Testing: Explicitly states, "Clinical data was not provided for the class III hip stem."
Therefore, I cannot extract the requested information to fill in the acceptance criteria table or describe a study proving the device meets acceptance criteria as an AI/algorithm.
If this were a submission for an AI-based device, the missing information would be crucial for FDA review. The current document describes a traditional orthopedic implant, where "acceptance criteria" are typically met through engineering testing (like fatigue strength), material compatibility, and demonstrated substantial equivalence to predicate devices, rather than statistical performance metrics of an algorithm.
§ 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.