(266 days)
Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
- Osteoarthritis
- Post-traumatic arthrosis
- Focal avascular necrosis of the humeral head
- Previous surgeries of the shoulder that do not compromise the fixation
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the humeral head (with Short Humeral Stems)
- Fractures of the proximal humerus (with Standard or Long Stems)
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.
The INHANCE™ Hybrid Anatomic Glenoid Implants are offered in five sizes: X-Small (21.5mm), Small (24.0mm), Medium (26.5mm), Large (29.0mm), and X-Large (31.5mm). The Glenoid Implants consist of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) articulation surface and fixation ring along with an additively manufactured Ti-6Al-4V (titanium alloy) central fixation post.
The INHANCE™ Hybrid Anatomic Glenoid Implants have a lateral surface that is concave and designed to articulate with the Humeral Heads from the Ignite Anatomic Stemmed and Stemless Shoulder Systems that are indicated for use in total shoulder arthroplasty.
The provided document is a 510(k) summary for a medical device (INHANCE™ Hybrid Anatomic Glenoid Implant) and does not describe a study involving algorithms, AI, or human readers. Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove a device meets criteria in the context of AI/algorithm performance.
The document focuses on demonstrating substantial equivalence of a new glenoid implant to existing predicate devices based on non-clinical testing of mechanical properties, biocompatibility, and material characteristics.
The following points are explicitly stated in the document:
- Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Hybrid Anatomic Glenoid Implants to the predicate device."
- Studies performed are non-clinical, mechanical, and material evaluations.
Therefore, the questions regarding acceptance criteria and studies for AI/algorithm performance cannot be answered from the provided text.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. 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. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”