(86 days)
The OrthoSolutions 'System26' cannulated screws (headed and headless compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless compression and Twist-Off) bone screws are applicable, as well, for bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
'System26' non-cannulated 2.0mm (headed, headless compression and Twist-Off) bone screws and cannulated (headed and headless compression) bone screw sizes of 2.0mm, 2.5mm 3.0mm are indicated for treating small bone fractures as well as performing osteotomies, arthrodesis and joining cancellous bone fragments in the upper and lower limb and extremities.
'System26' cannulated bone screw sizes (headless compression and headed with optional matching washer) of 4.0mm, 5.0mm, 6.5mm, and 8.0mm are indicated to be used with large and long bones. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive bone fracture/joint reconstructions; Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus; Fractures of the tibia; Cooper fractures of the tibia; Bone fractures of the radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Bone fractures of the acetabulum and dorsal pelvic ring; Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Bone fractures of the calcaneus and talus; Arthrodesis of the ankle joint; Arthrodesis of foot joints and; Avulsion fractures.
The OrthoSolutions ‘System26’ Bone Screws are not intended for spinal use.
OrthoSolutions 'System26' Bone Screws are comprised of noncannulated/cannulated bone screws and washers manufactured from Titanium Alloy (to ISO 5832-3/ASTM F136) for implantation within the human body. The instrumentation is made from medical grades of stainless steel and silicon. The 'System26' implants are threaded screws offered in both a 'headed' and 'headless compression' design. The implant screws are available in a range of diameter sizes between 2mm thru 8mm, (each identified with a Type III color anodising) with lengths between 10mm (shortest length) and 120mm (longest length). The implant screw devices (headed with washers and headless compression) and associated instrumentation are available in specifically designed, modular trays and are provided 'Non-sterile' to the end user for 'Single Use'. The 'System26' instruments include guide wires and size specific guides, drill bits and size specific guides, tissue protectors, depth gauges, countersinks, screw driver shafts, ratcheting screw driver handles and bone distractors. These instruments are used to ensure correct positioning and placement of the screws.
The provided text is a 510(k) Summary for the OrthoSolutions 'System26' Bone Screws. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
The document is for a traditional medical device (bone screws), not an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this submission.
The "study that proves the device meets the acceptance criteria" mentioned in the document is an "Engineering Analysis" to demonstrate "Substantial Equivalence (SE)" to predicate devices. This type of analysis typically involves comparing material properties, geometric dimensions, mechanical testing results (if applicable), and intended use of the new device against the predicate devices. It does not involve performance metrics like sensitivity, specificity, or AUC that would be seen in an AI/ML device study.
Therefore, I cannot provide the requested information for an AI/ML device based on the provided text.
§ 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.