(99 days)
The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the device.
The OsteoMed Foot Plating System implants are intended for single use only.
This submission describes the OsteoMed Foot Plating System consisting of various shape and sizes plates featuring compression, locking, elongated or compression elongated holes, and ulated locking, non-locking and cannulated screws, implantable K-wires, washers, and angulated instrumentation. The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device. All implants are intended for single use only. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, , or other bones appropriate for the size of the device.
The implants are made of Titanium (ASTM F-67, ASTM F-136, or ASTM F-1472) or Stainless Steel (ASTM F-138 or ASTM F-139). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
The provided text does not contain information about acceptance criteria or a study proving that the OsteoMed Foot Plate and Screw Rigid Fixation System meets such criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, materials, design, and operational principles.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details.
The document explicitly states: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices we believe that the OsteoMed Foot Plating System does not raise any new safety or effectiveness issues." This statement suggests that the clearance was based on demonstrating equivalence to existing, legally marketed devices rather than on a new performance study with specific acceptance criteria as you've outlined.
§ 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.