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The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

The Synthes 1.6 mm burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.6 mm or 1.9 mm emergency self-tapping & self-drilling screws.

This 510(k) premarket notification for the "Synthes Low Profile Neuro System" does not include any acceptance criteria or details of a study that proves the device meets such criteria.

The document is a clearance letter from the FDA (Form 510(k)) indicating that the device has been found substantially equivalent to a previously marketed predicate device. This type of submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device, often through comparative information rather than new performance studies with pre-defined acceptance criteria.

Therefore, I cannot populate the requested table or provide answers to the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth. These elements are typically found in detailed design validation reports or clinical study summaries, which are not part of this 510(k) summary.

Key takeaway from the provided document:

• Substantial Equivalence: The FDA's clearance is based on the finding that the Synthes Low Profile Neuro System is substantially equivalent to the predicate device (also the Synthes Low Profile Neuro System, implying perhaps an update or modification rather than a completely new design) for the stated indications for use.
• No new performance data presented: This specific document does not describe new performance testing with acceptance criteria or a study designed to prove the device meets those criteria.

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