(224 days)
HBS2 Headless Bone Screw is used for the treatment of intraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of:
HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures of the processus styloideus ulnae, Proximal radial head fractures
HBS2 MINI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures of the processus styloideus radii
The HBS2 Headless Bone Screws are used in the field of hand surgery, accident surgery and reconstructive surgery, and in orthopedics for the treatment of intraarticular and extra articular fractures and pseudo arthroses of small bone fragments, and for arthrodesis on small joints.
The system consists of various screws and instruments for different treatment options.
HBS2 screws are cannulated, self-drilling, self-cutting, have a reversing thread and are available in two diameters with different thread lengths.
HBS2 MIDI screws (magenta) are available with a diameter of 2.0 mm (shaft) and in different lengths. HBS2 MINI screws (green) are available with a diameter of 1.7 mm (shaft) and in different lengths too.
These devices are delivered in non-sterile condition and must be reprocessed before use. All implants are made out of Ti6Al4V 3.7165.
The provided text is a 510(k) summary for the HBS2 Headless Bone Screw. It details the device's indications for use, description, classification, and comparison to predicate devices. It explicitly states that no clinical studies were performed for this device, and therefore, an AI/ML-based study with acceptance criteria, ground truth, and expert evaluation as described in the prompt is not applicable to this document.
The document primarily focuses on non-clinical tests to demonstrate substantial equivalence to legally marketed predicate devices. The non-clinical tests are summarized in a table, which includes standards for biological safety (cytotoxicity, chemical analysis, characterization of organic extractable, bioburden, LAL endotoxin, particle) and mechanical safety (torsional properties, driving torque, axial pullout strength, static and dynamic 3-point bending).
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML-based device and its study, as this document pertains to a medical device that was evaluated through non-clinical testing and substantial equivalence, not through AI/ML performance studies.
§ 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.