(79 days)
The AOS Small Fragment Plating System is intended to be used for fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, including osteopenic bone.
The AOS Small Fragment Plating System consists of titanium plates in various configurations and sizes. The system includes non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.
This document describes a 510(k) premarket notification for the "AOS Small Fragment Plating System."
It indicates that the device is substantially equivalent to legally marketed predicate devices based on indications for use, similar shape and design, and fundamental technology.
Here's the breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Four-point bend strength (based on ASTM F382-14)
- Variable Angle Locking Mechanism strength (screw-plate interface) | Substantially Equivalent to Predicate Devices:
- The AOS Small Fragment Plating System met the mechanical performance requirements tested, demonstrating substantial equivalence to the predicate devices in terms of four-point bend strength and variable angle locking mechanism strength. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "comparative mechanical testing" but does not detail the number of samples tested for each device or test.
- Data Provenance: Not specified. The testing was reported by Advanced Orthopaedic Solutions, Inc., located in Torrance, CA, USA, but the origin of the data itself (e.g., specific lab, country) is not mentioned. The testing is likely prospective, as it was performed specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This device is a physical implant (plating system), not a diagnostic or AI-driven device that requires expert review for ground truth establishment. The "ground truth" for this device's performance is established through mechanical testing against industry standards (ASTM F382-14) and comparison to predicate devices, rather than expert medical interpretation of data. Therefore, this question is not applicable in the typical sense for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in diagnostic studies. For mechanical testing, the results are objectively measured per a defined protocol.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical orthopedic implant system, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established through mechanical testing data demonstrating that it meets predefined physical and mechanical properties and performs comparably to the predicate devices. The ASTM F382-14 standard provides the benchmark for performance, and the predicate devices serve as the comparative ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The "training" for such devices involves adherence to engineering design principles and manufacturing quality control.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.