(89 days)
The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
The Bone Bolt System consists of various sizes and lengths of bolts and nut-sleeves, which are implanted from opposing bone surfaces to provide stabilization of bones and bone fragments for the fixation of fractures, arthrodeses, and osteotomies. The bolts and nut-sleeves are cannulated for use with guidewires for precise placement in bone. The Bone Bolt System includes optional washers of various sizes.
The provided text describes the 510(k) premarket notification for the "Bone Bolt System." It outlines the device's indications for use, description, predicate devices, materials, and performance data. However, the document does not contain information about a study proving the device meets acceptance criteria related to an AI/machine learning model.
The performance data section explicitly states: "No clinical or animal testing was conducted." The performance characterization was based on in vitro mechanical testing (Torsional Strength Testing, Driving Torque Testing, Axial Pull-out Strength Testing, Static and Dynamic Bending Testing) according to ASTM standards.
Therefore, I cannot fulfill the request to provide the detailed information about an AI/ML study, including:
- A table of acceptance criteria and reported device performance (for an AI/ML model)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and qualifications
- Adjudication method for the test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details
- Standalone (algorithm-only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
The document describes a traditional medical device (metallic bone fixation fastener) and its clearance based on substantial equivalence to predicate devices, supported by in vitro physical performance data. The questions posed are highly relevant to the evaluation of AI/ML-based medical devices, but this document does not pertain to such a device.
§ 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.