(41 days)
The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and ostetotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Synthes 3.0 mm Headless Compression Screws are cannulated and are self-drilling / self-tapping with a stardrive mechanism, and have a threaded head which can be countersunk into the bone. The screws are available in short and long thread lengths ranging from 10 mm to 40 mm. The screws are available in Stainless Steel and a Titanium Alloy.
The provided text is a 510(k) summary and FDA clearance letter for the Synthes 3.0 mm Headless Compression Screws. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.
The 510(k) pathway for medical device clearance is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through extensive clinical studies in the same way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory clearance based on equivalence rather than detailed performance study results against predefined acceptance metrics.
Here's an explanation of why the requested information isn't available in this document type:
- Acceptance Criteria & Device Performance Table: This type of detail would typically be found in a performance testing report (e.g., mechanical testing, biocompatibility testing) or a clinical study report. The 510(k) summary doesn't include these specific performance metrics or a table comparing them to acceptance criteria.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type for Test Set, Training Set Sample Size, Training Set Ground Truth: All these points relate to specific clinical study design and execution, which are not detailed in a 510(k) submission unless it's a very complex device requiring specific clinical data for equivalence, or if a new indication requires it. For a bone screw, the primary evidence relies on existing predicate devices, material properties, and mechanical testing.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a performance study report.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.