(131 days)
Inion CPS Orbital Plates are intended for use in trauma and reconstructive procedures of the orbital cavity as part of the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.
The Inion CPS® Orbital Plate fixation plates made of resorbable polylactic acid/trimethylcarbonate copolymer: This copolymer degrades in vivo by hydrolysis into L-lactic, D-lactic and TMC monomers which are then metabolised by the body.
Inion CPS® Orbital Plates are of dimensions: length: 25-40 mm, width: 24-40 mm, thickness: 0.5 mm. The fixation of the plates with Inion CPS® ø1.5 mm screws. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized.
The Inion CPS® Orbital Plates provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.
The Inion CPS® Orbital Plates are designed to be used with customized instrumentation consisting of template, drill bits, bone taps, screw driver, plate benders and a heating device.
The provided text describes a 510(k) summary for the Inion CPS® Orbital Plate, focusing on the device description, indications for use, and performance testing for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in discussions of AI/ML device performance.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI performance, ground truth, or study details.
The document primarily discusses:
- Device Description: Resorbable polylactic acid/trimethylcarbonate copolymer plates for orbital cavity trauma.
- Indications for Use: Trauma and reconstructive procedures of the orbital cavity as part of the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.
- Performance Testing: Mechanical shear test, biomechanical fixation test, in vitro degradation testing, functional and handling test, and simulated clinical use test were performed to demonstrate substantial equivalence to a predicate device (Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System K010352). These tests verified strength, fixation, degradation profile, and functionality.
No information regarding the performance of an AI/ML device, its acceptance criteria, or a study to demonstrate its performance against such criteria is present in the provided text.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.