(27 days)
The POLARCUP® Dual Mobility System is indicated for:
- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis.
- . Fracture or avascular necrosis of the femoral head
- Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
- All forms of osteoarthritis .
- Patients with hips at risk of dislocation .
- . Femoral neck fracture or proximal fracture to hip joint
The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement. The POLARCUP® Dual Mobility System is intended for single use only.
The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. This dual mobility design results in higher intra-prosthetic stability to address the treatment of patients with a high risk of dislocation (especially for elderly patients) or patients with recurrent dislocation. The subject of this premarket notification is the addition of an outer hydroxylapatite coating to the currently available acetabular shell.
The provided text is a 510(k) summary for the POLARCUP® Dual Mobility System, a medical device. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/software validation.
Instead, this document describes:
- The device (POLARCUP® Dual Mobility System) and its components (metal shell, plastic liner).
- Its intended use (treatment of advanced degeneration of the hip joint, fractures, failures of previous hip surgery, osteoarthritis, and patients at high risk of dislocation).
- Its classification and regulatory information.
- Its technological characteristics, specifically noting that mechanical data indicates it can withstand in vivo loading.
- Its substantial equivalence to predicate devices (other hip prostheses from Smith & Nephew).
- A brief conclusion that, based on similarities to predicates and mechanical testing, the device is substantially equivalent.
Therefore, I cannot provide the requested information because the document does not describe acceptance criteria for an AI/software device, nor does it detail a study that proves such a device meets acceptance criteria.
The questions you've asked (about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are all highly relevant to the validation of AI/Software as a Medical Device (SaMD) or AI-enabled medical devices. This document, however, is for a physical orthopedic implant and does not involve AI or software in the way your questions imply.
§ 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.