(75 days)
The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
The Synthes 2.4 mm Universal Locking Plate System is a plate and screw system intended for mandible trauma and reconstruction procedures. The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws. The system includes Threaded Drill Guides and 2.4 mm Insert Screws. The device is provided non-sterile and requires moist heat sterilization prior to use.
This document pertains to a 510(k) summary for a medical device (Synthes 2.4 mm Universal Locking Plate System). It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of diagnostic or AI-driven performance as described in your request.
The document discusses:
- Device description: Synthes 2.4 mm Universal Locking Plate System, intended for mandible trauma and reconstruction.
- Components: Plates, self-tapping cortex and/or locking screws, threaded drill guide, 2.4 mm insert screw.
- Sterilization: Device provided non-sterile, recommendations for moist heat sterilization provided.
- Equivalence claim: Based on mechanical test results, the manufacturer believes the devices are "at least equivalent" to the Synthes 2.7 mm Reconstruction Plate System.
Therefore, I cannot extract the information requested as it is not present in the provided text. The terms like "acceptance criteria," "device performance," "sample size," "ground truth," "experts," "adjudication," "MRMC study," "standalone performance," and "training set" are irrelevant to the content of this 510(k) summary, which focuses on a physical medical implant and its safety/equivalence from a mechanical perspective.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters, with a circled "R" symbol to the left of the word. To the right of the word "SYNTHES" is the number "K96147" written in black ink. The number appears to be handwritten.
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
JUN 26 1996
(610) 647-9700 Contact: Angela Silvestri April 1996
Device: Synthes 2.4 mm Universal Locking Plate System, as compared to Synthes 2.7 mm Reconstruction Plate System.
The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws.
The following instrumentation is used with the 2.4 mm ULPS:
Threaded Drill Guide is used for guiding the drill bit to bone by threading the tip into the plate's screw hole. The bore (inside diameter) of the drill guide is dependent upon the screw size when selected since each screw diameter requires a specific drill diameter. They are available with bores from 1.5 mm to 2.5 mm.
2.4 mm Insert Screw is used by the surgeon while bending the plate to avoid deforming the threaded screw holes. The inserts are screwed into the plate holes prior to bending and removed once the bending operation is complete.
Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance."
Based on mechanical test results, we believe that the devices are at least equivalent.
§ 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.