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Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Those are designed with various sizes of partially and fully threaded to satisfy with different kinds of fractures as using on small bones or large bones. The subject components are plates available in width from 3.8mm to 17.5mm, in total length from 15mm to 319mm and the hole numbers are 2 to 22 holes. The threads of the screws are available in diameters from 2.4mm to 7.3mm, and in length from 6mm to 180mm. Those screws have been designed for fitting on different symptoms of fractures and the plates have been designed to distribute for local anatomies and should be necessary to be used with its intended screws. Basically, the screws used to fasten plates onto bone, or, as lag screws, to hold together fragments of bone. We have totally the same kinds of the screws and plates as the predicate devices' functions, but with self-tapping or self-drilling to promote the operation efficiency. Besides this, we have another alternative screws and plates which are designed with locking head of the screws taken place with the traditional screw head, and threaded aside locking hole of the plates taken place with the aside plain hole of the plates.

This document describes a 510(k) premarket notification for a medical device and is a submission for substantial equivalence to a predicate device, not a study proving the device meets acceptance criteria via clinical trials or AI performance metrics. Therefore, many of the requested fields regarding acceptance criteria, AI performance, ground truth, expert involvement, and sample sizes for training/test sets are not applicable in this context.

Here's the information extracted from the provided text, modified to acknowledge the nature of a 510(k) submission:

1. Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to a predicate device through engineering performance tests, rather than clinical outcomes. The device performance is reported as meeting or being comparable to the predicate device in specific mechanical tests.

2. Sample Size for Test Set and Data Provenance

• Sample size used for the test set: Not explicitly stated. The document refers to "test results" from mechanical tests rather than human subject testing or specific data sets.
• Data provenance: The mechanical tests were performed on the "Syntec Osteo-plate and screw Fixation" device. The provenance of the data is internal testing conducted by Syntec Scientific Corporation in Taiwan. The tests compare the new device to the predicate device (Syntec-Taichung Non-sterile Bone Plate and Screw implants). This would be considered internal, laboratory-based, prospective testing of the device prototypes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a 510(k) submission for a physical medical device based on mechanical testing, not a study involving expert-established ground truth for a diagnostic or AI device.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study requiring human review or consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. This is a 510(k) submission for a physical medical device. MRMC studies are typically for diagnostic devices or AI systems.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a 510(k) submission for a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is the established mechanical performance of the legally marketed predicate device (Syntec-Taichung Non-sterile Bone Plate and Screw implants) and compliance with recognized industry standards (ASTM F138, ASTM F136) for material properties. The claim is that the new device performs equivalently in these mechanical tests.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device. There is no "training set" in the context of AI or machine learning. The device design is based on engineering principles and existing designs.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, no ground truth was established for it in the context of this 510(k) submission.

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