(89 days)
The Renewal™ Acetabular Cup System is intended for primary or revision reconstruction, with or without bone cement, of the acetabular portion of severely disabled and/or very painful hip joints, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
- patients with failed previous surgery where pain, deformity, or dysfunction persists;
- revision of previously failed hip arthroplasty; and
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Renewal™ Acetabular Cup System consists of metal acetabular shells and UHMWPE acetabular liners.
The Renewal™ Acetabular Shell will be available in a hemispherical titanium alloy shell with and without a 2 mm peripheral rim flare. The shells will be coated with commercially pure titanium porous beads.
Design features of the Renewal™ Acetabular shell are summarized below:
- Total hemispherical design .
- Hemispherical design with a 2 mm peripheral flare .
- Coated with CPTi porous beads ●
- . No-Hole, 3-hole, 5-Hole, and 9-Hole options
- Threaded apical hole plug
The Renewal™ Acetabular Liners will be available with 0°, 10°, 15°, 20° overhangs with/without a 6+mm lateralized shift. The liner's internal geometry will be intended to be used with existing femoral heads manufactured from cobalt chrome or ceramic. The Renewal™ liner's external geometry will be designed to accept the Renewal™ Acetabular Shells.
Design features of the Renewal™ Acetabular Liner are summarized below: - 360° liner overhang positioning options .
- Features an easy-to-assemble snap lock system to lock the liner into the shell .
- . The lip of the 10° and 20° liners will be full hemispheres
- The lip of the 15° liner will be machined to 180° .
- The liners will be offered with 0°, 10°, 15°, and 20° overhangs .
- The 0° and 10° liners will also be offered with a 6+mm lateralized shift ●
- Internal diameter will have a 2mm chamfer to minimize impingement. .
The thinnest part of any UHMWPE articulating insert will be greater than 4mm if attached to a metal backing.
This document is a 510(k) summary for the Orthopaedic Innovations Renewal™ Acetabular Cup System. It is an FDA submission seeking clearance to market a medical device, and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel device or a clinical trial.
Therefore, the provided text does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Instead, the document asserts that the device is "substantially equivalent" to previously cleared competitive devices based on its intended use, material, type of interface, and design features. It also mentions "testing results provided within the Premarket Notification" but does not detail what those results were, what the acceptance criteria for those tests were, or how they were quantified in terms of device performance.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- Acceptance Criteria and Reported Device Performance: Not provided. The document states "The safety and effectiveness of the Renewal™ Acetabular Cup System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." However, it does not enumerate specific acceptance criteria or report performance against them.
- Sample Size for Test Set and Data Provenance: Not provided.
- Number of Experts and Qualifications: Not applicable as no expert-adjudicated test set is described.
- Adjudication Method: Not applicable as no expert-adjudicated test set is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. This type of study is typically used for diagnostic devices involving human interpretation, which is not directly applicable to an acetabular cup system.
- Standalone (Algorithm Only) Performance: Not applicable. This is a medical device (implant), not an algorithm.
- Type of Ground Truth Used: Not applicable in the context of an "AI" or diagnostic device study. The "ground truth" for an implant's safety and effectiveness relies on material testing, design validation, and clinical outcomes (which are not presented here, but are typically part of post-market surveillance or larger clinical trials).
- Sample Size for Training Set: Not applicable. This is not an AI/ML device.
- How Ground Truth for Training Set was Established: Not applicable. This is not an AI/ML device.
In summary, the provided text is a regulatory submission focused on "substantial equivalence" for a physical medical implant (acetabular cup system), not a study report detailing performance metrics against specific acceptance criteria for an AI or diagnostic device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.