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510(k) Data Aggregation
(97 days)
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.
Synthes 3.5mm Quadrilateral Surface Plates consist of metallic plates pre-shaped to fit the quadrilateral surface of the pelvis. The plates are provided in short, standard, and long versions
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a medical device (Synthes 3.5mm Quadrilateral Surface Plates).
It includes information such as:
- Sponsor and device name
- Classification and predicate device
- Device description and indications for use
- A determination of substantial equivalence by the FDA
However, it does not detail:
- Specific acceptance criteria (e.g., performance metrics, thresholds)
- Any study design, test set characteristics, expert qualifications, adjudication methods, or results of performance testing that would demonstrate conformance to such criteria.
Therefore, I cannot fulfill your request for the table and study details based on the given input.
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