(23 days)
Ø 1.5 and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX are used for plate fixation fasteners in trauma and constructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; orbital floor fractures; trauma of the midface or craniofacial skeleton and reconstructive procedures of the midface or craniofacial skeleton.
Ø 2.0 mm screw models of BioSorb™ FX can be used for plate fixation fasteners with BioSorb™ 2.0/2.4 O/M plates in trauma and reconstructive procedures in the midface, maxilla and mandible. Especially in mandible BioSorb™ FX 2.0/2.4 O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).
Ø 1.5mm and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families. Originally the screw head design of Ø 1.5 and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families was designed as a crosshead screw. Further development of head design for easier insertion of 0 1.5mm and 2.0mm screw models continued and finally new head design with outer attachment of screw driver was finalized. The main purposes were improvement of installation properties without sacrificing torsion properties of the screw model. The revision of head design has no effect on intended use, principles of operation, production methods, raw material or sterilization. The screw drivers are revised accordingly, but other parts of instrumentation are remaining unchanged.
This 510(k) summary describes a modification to an existing medical device, specifically screw head redesigns for bioabsorbable fixation fasteners. As such, the submission focuses on demonstrating substantial equivalence to the predicate devices rather than proving a new device meets specific acceptance criteria through a clinical study. The provided text does not include the information requested regarding conventional acceptance criteria and a study proving those criteria are met, as this type of submission is for device modification and substantial equivalence.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on explaining that the new screw head design has no effect on intended use, operating principles, production methods, raw materials, or sterilization, and thus is substantially equivalent to the previously cleared devices. It lists contraindications and indications for use, but these are for the device family as a whole and not specific to demonstrating performance of the new head design against defined acceptance criteria.
§ 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.