(28 days)
The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).
The plate is manufactured from commercially 316LS Stainless Steel which in conformance with ASTM F138 and an alternative material which is Pure Titanium. The plates designed are from 1.5mm to 6.5mm thickness, from 6.5mm to 17.5mm width, and are available variously in length from 24.0mm (2 holes) to 394.0mm (22 holes). It should assembly with the same screw that was the predicate device in concurrence by FDA, (K983495).
This 510(k) summary (K090839) describes the Syntec-Taichung Bone Plates and Screw Implants. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) submission, and its purpose is to demonstrate substantial equivalence to a predicate device, not necessarily to present performance studies in the way a clinical trial or a detailed engineering test report would.
Here's why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria: The text does not list any specific performance metrics (e.g., tensile strength, fatigue life, accuracy, sensitivity, specificity) with corresponding thresholds that the device needs to meet.
- No Study Details: There is no description of a study conducted to evaluate the device's performance against any criteria. The document focuses on material composition and intended use, comparing it to a predicate device.
- Focus on Substantial Equivalence: The primary objective of this 510(k) is to demonstrate "Substantially Equivalence" to an already cleared predicate device (K983495), implying that its performance is presumed to be similar to the predicate based on material, design, and intended use, rather than through new, explicit performance studies detailed in this summary.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in performance testing reports, clinical study summaries, or detailed engineering analyses, which are not present in this 510(k) summary.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.