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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).

This system makes up of non-sterile bone plate and screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. They are principally differentiated by their function. Thus there are four kind of styles: Dynamic Compression Plate (DCP), tubular, special, and mini. The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. Every plate is divided various types as following: DCP (narrow, narrow lengthening, broad, and broad lengthening straight), Tubular (semi-tubular, one-third, and quarter), Special (L-shaped, T-shaped, spoon, cobra, lateral tibial head, condylar buttress, head, and hook), and Mini (T-shaped, Straight, L-shaped, condylar, special, and reconstruction). The plates are manufactured from commercially 316 LS stainless steel; however, all of titanium plates except mini are included above-style. They range in thickness from 1.0 to 5.0 mm, width from 3.8 to 17 mm, length from 17 to 262 mm, and hole number from 2 to 20 holes.

On the other hand, the screws used either to fasten plates or similar devices onto bone, or. as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Thus there are four kind of style: cortex, cancellous, malleolar, and cannulated. All screws have a hexagonal recess; this feature has proven itself to be of great advantage at the time of the screw removal and insertion.

The screws are manufactured from commercially 316 LS stainless steel. However, all of titanium screws except malleolar were included above-style. They range in thread diameter from 1.5 to 7.3 mm, total length from 6 to 150 mm, and hexagonal socket width from 1.5, 2.5,or 3.5 mm.

This document does not describe any acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text is a 510(k) summary for a medical device (Syntec-Taichung Non-sterile Bone Plate and Screw Implants) and the FDA's marketing clearance letter for that device.

Here's why it doesn't contain the requested information:

• 510(k) Submissions: A 510(k) submission is a premarket notification demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. It typically relies on comparisons of design, materials, indications for use, and performance characteristics to a previously cleared device, rather than new clinical or performance studies with specific acceptance criteria that an AI device would require.
• No AI Component: The device described (bone plates and screws) is a physical, passive implant. It has no AI, software, or diagnostic component that would require assessment against performance metrics like sensitivity, specificity, accuracy, or AUC.
• Lack of Study Description: There is no mention of any study conducted to measure the device's performance, let alone one that would establish ground truth, sample sizes, or expert adjudication. The "Basis of Substantial Equivalence" section explicitly states it's based on a comparison to an existing device, not a performance study.

Therefore, I cannot populate the table or provide answers to the questions you've posed, as the input document does not contain this type of information.

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