(277 days)
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.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Compression strength of plates and screws | Demonstrated substantial equivalence to predicate device. |
| Pull-out strength of screws | Demonstrated substantial equivalence to predicate device. |
| Torsional strength of screws | Demonstrated substantial equivalence to predicate device. |
| Material composition (ASTM F138, ASTM F136) | Complies with ASTM F138 and ASTM F136 standards. |
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.
§ 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.