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510(k) Data Aggregation
(356 days)
Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.
Synthes Distal Radius Fixator is intended for the fixation of the distal radius.
Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are:
- Delayed treatment of dislocated and stiff elbows .
- Chronic, persistent joint instability .
- Acute joint instability after complex ligament injuries .
- . Unstable elbow fractures
- Additional stabilization of post-operative unstable internal fixation
The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator System for adults (rod diameter: Øl 1 mm), and with components of the Synthes Medium External Fixator System (rod diameter: Ø8mm) for children and small stature adults.
The Synthes External Fixation Devices, MR Conditional consists of previously cleared Medium External Fixation, Distal Radius Fixator, Low-profile Wrist Fixator and Elbow Hinge Fixator devices that are used to construct an external fixation frame.
The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for the "Synthes External Fixation Devices, MR Conditional."
The document is a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to predicate devices, not on performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
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(40 days)
VIVACAP HR is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I
Two surface cavities such as MO, DO, FO, LO
Three surface cavities such as MOD, FOD.
Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental filling material called VIVACAP HR. This document grants market clearance based on substantial equivalence to a predicate device and details the intended use of the product.
Crucially, this document does not contain any information regarding clinical studies, acceptance criteria for device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.
Ask a specific question about this device
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