(24 days)
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation of fractures and osteotomies of long bones.
The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method. The Tivanium 3.5 mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.
I am sorry, but the provided text is a 510(k) summary for a medical device (NCB Polyaxial Locking Plate System). It describes the device, its intended use, comparison to predicate devices, and regulatory information.
However, it does not contain the specific information required to answer your request about acceptance criteria for a study and its proving evidence.
The "Performance Data (Nonclinical and/or Clinical)" section explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that a clinical study with acceptance criteria for device performance, as you've requested, was not performed or at least not submitted as part of this 510(k). Instead, the performance data cited is: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance." This likely refers to non-clinical, benchtop testing to ensure the device meets engineering specifications, not a clinical study on patient outcomes or human reader performance.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This 510(k) summary is for a bone fixation system, not an AI/software device that would typically involve the type of performance evaluation you are asking about (e.g., assessing accuracy, sensitivity, specificity, and human reader improvement with AI).
§ 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.