(70 days)
The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that care common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatassi, fibular shaft, malleolus fractures where indicated, The DRG Medium Screw™ System is indicated for:
Humeral Shaft Distal and proximal humerus Distal and proximal radius and ulna Radial and ulna shaft
Distal tibia and ankle Talus-calcaneus-matatarsal Fibular shaft and Malleolus fractures Intermediate Bone Fractures
The Dolphin Medical Technologies DRG Medium Screw™ System will be offered in Ti-6A1-V ELI. It will be available in common styles and assorted lengths for bone fixation and stabilization. A range of twenty six screw lengths will be made available in 4.5 mm diameter (16-72 mm) with four different distal thread length dimension (6.5mm, 16mm, 26mm). The screws are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated, on center axis.
The provided document is a 510(k) premarket notification for a medical device (DRG Medium Screw™ System), which focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the requested information elements (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size) are not applicable in the context of this document.
Explanation:
- 510(k) Premarket Notification: This regulatory pathway is used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and technological characteristics, and showing that the new device raises no new questions of safety or effectiveness. It does not inherently require a clinical study with predefined acceptance criteria for device performance in the same way a PMA (Premarket Approval) or De Novo application might.
- Performance Standards: The document explicitly states: "No performance standards applicable to the Bone Screw have been established by the FDA." Instead, it relies on meeting voluntary material standards (ASTM F136-84) and demonstrating equivalence to existing devices.
- Substantial Equivalence: The primary "proof" in this document is the comparison to a list of existing, approved bone screws (e.g., Ace Medical Company K903810, Osteomed K924018). The study that "proves" the device meets acceptance criteria is implicitly the comparison against these predicate devices based on their known design, materials, and clinical history.
In summary, the document addresses substantial equivalence, not performance acceptance criteria through a dedicated study.
§ 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.