(207 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip: fracture of the pelvis and diastrophic variant; inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
When used in combination with an appropriately sized Reflection metal acetabular shell, Reflection Acetabular Liners are intended for cemented or uncemented use. Reflection All Polyethylene Cups are intended for cemented use only. Reflection Acetabular Liners and All Polyethylene Cups are intended for single use only.
The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Reflection Acetabular System (i.e. acetabular liners and all polyethylene cups)
There have been no changes in indications for use, design, or material property changes to any Reflection Acetabular Liner or All Polyethylene Cup components that will be sterilized using the VHP® process.
The VHP® sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization of Reflection Acetabular System components (acetabular liners and all polyethylene cups) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations.
The provided text describes the 510(k) summary for the UHMWPE Components of the Reflection® Acetabular System, focusing on the VHP® sterilization process. This document does not describe a study involving an AI/Machine Learning device or its performance criteria.
Instead, it details the sterilization process validation for medical devices (acetabular liners and all polyethylene cups made from UHMWPE). The "acceptance criteria" and "device performance" in this context refer to the sterilization efficacy and the material's integrity after sterilization, not the diagnostic performance of an AI system.
Therefore, I cannot fulfill your request for information related to AI/Machine Learning device acceptance criteria and study details based on the provided text. The questions you've asked (sample sizes for test sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are specific to AI/ML device validation, which is not what this document addresses.
However, I can extract the information related to the sterilization process validation as it appears in the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microbicidal effectiveness of vaporized hydrogen peroxide | Demonstrated |
| Effects of VHP® sterilization cycle on UHMWPE materials in which the product is packaged | Demonstrated |
| Process validation efforts to demonstrate effectiveness and reproducibility, resulting in a Sterility Assurance Level (SAL) of at least 10⁻⁶ | Verified achievement of a SAL of 10⁻⁶. Safe, reproducible, predictable, and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek®/Mylar® pouches. |
Important Note: The questions related to sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established are not applicable to this document, as it concerns the validation of a sterilization process, not an AI/ML 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.