(52 days)
Metallic Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
Metallic Locking Compression Bone Plates and Screws System contains (1) locking compression plates (LCPs) with various specifications, (2) two kinds of screws with various specifications and (3) various specific instruments. Locking Compression Plates that made of Titanium. They have combi-holes. the threaded hole sections on the plates for locking screws provides ability to create fixed-angle constructs; the un-threaded hole sections for cortex screws allows utilization of familiar AO plating techniques. The limited-contact design of LCPs reduces plate-to-bone contact, thus limiting vascular trauma.The screws are available in locking screws and cortex screws. There are various instruments specific to the proposed device intend for completing the surgery.
Here's a breakdown of the acceptance criteria and study information for the Metallic Locking Compression Bone Plates and Screws System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Test) |
|---|---|
| ASTM F382-99 (Reapproved 2008) | Static and Dynamic Performance tested per ASTM F382 |
| ASTM F543-07 | Torsional, Driving Torque, and Pull out strength tested per ASTM F543 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical tests performed to demonstrate that the device met design specifications and was substantially equivalent to predicate devices. It does not mention a traditional "test set" in the context of clinical data or a sample size of patients. Instead, the tests were conducted on the device components themselves.
- Sample Size for Test Set: Not applicable in the context of clinical data. The tests were performed on the device components.
- Data Provenance: The tests were conducted by the manufacturer, Tianjin Walkman Biomaterial Co., Ltd, located in Tianjin, P.R. China. The data would be considered "non-clinical" and laboratory-based, not patient-derived.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The performance was assessed against established engineering standards (ASTM F382 and F543).
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring adjudication. The device performance was compared directly to the specifications outlined in the ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical implant (bone plates and screws), not a software algorithm or AI-based diagnostic tool. Therefore, "standalone" performance in the context of an algorithm or AI is not relevant. The performance tests done were solely on the physical device components.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance was the specifications and requirements outlined in the relevant ASTM standards:
- ASTM F382-99 (Reapproved 2008) for metallic bone plates.
- ASTM F543-07 for metallic medical bone screws.
These standards define the acceptable mechanical properties and performance characteristics for such devices.
8. The Sample Size for the Training Set
This information is not applicable. As this is a submission for a physical medical device (bone plates and screws) and not a software/AI algorithm, there is no "training set" in the computational sense. The device's design and manufacturing are based on established engineering principles and materials science, not on machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. There is no concept of a "training set" or "ground truth for a training set" for this type of device 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.