(119 days)
The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the screw. The washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
Sonoma Cancellous Bone Screws and Washers are a family of stainless steel screws and washers used for various skeletal repairs where cancellous screw thread profiles are clinically desired. The screws are offered in range of diameters from 4mm to 7.3mm, in both cannulated and solid configurations. The screw dimensions including thread profile, thread length, core diameter, cannulation diameter (where applicable), head diameter, overall length, and driving socket size are equivalent to the predicate device. Where applicable, these features are dimensioned as described by ASTM F543-13 (i.e. 4.0mm and 6.5mm solid screws). The washers are sized according to screw diameter and can be used to prevent head subsidence in soft bone. The screws and washers are manufactured from 316 stainless steel per ASTM F138.
The provided text describes the Sonoma Cancellous Bone Screw and Washer and its regulatory submission. It does not present a study or acceptance criteria related to a medical device's performance in diagnosing or treating a condition, nor does it involve any form of AI or algorithm.
The information provided pertains to the substantial equivalence of a bone screw and washer to a predicate device, focusing on material, dimensions, and mechanical properties. The FDA 510(k) summary explains how the device meets regulatory requirements, not how it meets clinical performance acceptance criteria in a study involving human or image data.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth details, or training set information) because this document does not contain an AI/algorithm-related study or performance data for such criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.