(59 days)
The OR30 Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.
Indications
· 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, arthrodesis, hemiathroplasty, surface replacement athroplasty, or total hip replacement.
· All forms of osteoarthritis.
· Patients with hips at risk of dislocation.
· Femoral neck fracture or proximal hip joint fracture.
The OR3O Dual Mobility System is intended for single use only. The modular OR3O Liners and Inserts are to be implanted without bone cement.
The OR3O Hip System was originally cleared via K220959. The OR3O Hip System is a modular dual mobility implant system containing two distinct articulating surfaces. The hip system consists of a metal acetabular shell, diffusion hardened oxdized zirconium (OXINIUM DH) alloy liner, a cross-linked polyethylene (XLPE) Insert and a femoral head.
The purpose of this Taditional 510(k) is to add the MR safety information to the product labels and update the MR information within the package insert for the Snith & Nephew OR3O Dual Mobility System included within the scope of this 510(k). The subject OR30 Dual Mobility System is identical in design, technological characteristics, function, packaging, and sterilization to the commercially available predicate devices.
The provided text is a 510(k) summary for a medical device (OR30 Dual Mobility System), seeking clearance to market based on substantial equivalence to predicate devices. It primarily focuses on the device's design, materials, indications for use, and a specific change related to MR safety information.
This document does NOT contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria. It discusses the testing done for MR compatibility for a physical implant, not a software or AI device. Therefore, it's impossible to extract the requested information (acceptance criteria for a software device, test set details, expert ground truth, MRMC study, standalone performance, training set details) from the provided text.
The closest relevant section is:
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
"Magnetic Resonance Imaging (MRI) compatibility testing was performed and the results of the testing performed were evaluated and used to generate recommended MRI safety labeling for the subject devices. Testing and evaluation were performed in accordance with the standards listed below:
- Magnetically induced displacement force (ASTM F2052)
- Magnetically induced torque (ASTM F2213)
- Radiofrequency (RF) induced heating (ASTM F2182)
- MR image artifact (ASTM F2119)
Based on the MR assessment performed for the subject devices are MR Conditional and substantially equivalent to the predicate MRI 510(k) K211176."
This describes physical testing of the implant's interaction with MRI, not the performance of an AI/software.
§ 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.