(85 days)
The Synergy Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.
Synergy Cannulated Screw System
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "Synergy Cannulated Screw System" and a separate "510(k) Summary" for "DBX® Inject".
The first document (FDA clearance letter) states that the Synergy Cannulated Screw System is substantially equivalent to legally marketed predicate devices. It lists the regulation number, name, and product code.
The second document (510(k) Summary for DBX® Inject) describes the device, its intended use, and argues for its substantial equivalence to other cleared devices based on the absence of "new types of safety and effectiveness questions." It provides a table of indications for use for DBX® Inject (Putty and Paste forms).
Neither document includes details about:
- Specific acceptance criteria (e.g., performance metrics, thresholds)
- A study design or results that demonstrate the device meets any such criteria
- Sample sizes for test or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone performance studies
- Types of ground truth
- How ground truth was established
§ 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.