(144 days)
Surgical indications for the Avanta Orthopaedics Tendon Spacer include: Reconstruction of the flexor or extensor tendons of the fingers, thumb and wrist. Scared or adherent tendons following trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is a single-use, temporary implantation for 2-6 months.
The Avanta Orthopaedics Tendon Spacer is a device intended to be implanted made of silicone elastomer which is reinforced with dacron polyester mesh and suture. The device is intended to be used in the surgical reconstruction of a flexor or extensor tendon of the hand. The device may be implanted long enough to permit maturation of the tendon bed to the point at which it can nourish and lubricate the gliding tendon graft. The device may be implanted for a period of time from 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon or to function as a scaffold for soft tissue ingrowth.
The tendon spacer will be available in four sizes, 3,4,5 and 6 mm diameter and 24 cm in length:
The provided text is a 510(k) summary for a medical device (Avanta Orthopaedics Tendon Spacer) and does not contain information about acceptance criteria or a study proving the device meets said criteria using AI/ML technology. The document describes a physical implantable device, its intended use, and device description, but lacks any mention of AI/ML, performance metrics, or clinical study methodologies related to AI.
Therefore, I cannot extract the requested information from the given text.
§ 888.3025 Passive tendon prosthesis.
(a)
Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.(b)
Classification. Class II.