(294 days)
OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include:
- Opening wedge osteotomies of the foot (including osteotomies for Hallux Valgus).
- Opening wedge of Medial Cuneiform or Cotton osteotomies.
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy).
- Metatarsal/Cuneiform arthrodesis.
OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine
The OsteoSinter® EVANS and COTTON wedges are sterile, single use porous titanium implantable wedges, available in varied footprints and heights, intended to be used for correction of foot deformities.
The provided text does not contain information about acceptance criteria for a medical device or a study proving that the device meets such criteria within the typical context of a diagnostic AI/ML device.
This document is a 510(k) Premarket Notification for a physical medical device, the "OsteoSinter® EVANS and COTTON wedges and related accessories," which are sterile, single-use porous titanium implantable wedges used for internal bone fixation.
The discussion focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and material comparisons, not AI/ML performance metrics.
Therefore, I cannot provide the requested information from the given text as it pertains to AI/ML device acceptance criteria and studies. The document only describes traditional medical device equivalence testing.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.