(90 days)
The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
The Skeletal Dynamics Forearm Plating System include Midshaft Radius Plates and Midshaft Ulna Plates, manufactured from titanium alloy (ASTM F-136) and available in multiple lengths and hole configurations.
The provided text describes a 510(k) submission for the "Skeletal Dynamics Forearm Plating System." This type of submission is for medical devices, specifically bone fixation appliances, not AI or software medical devices. Therefore, the information requested regarding acceptance criteria and studies that prove device meets criteria for an AI/ML device (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical devices in the US.
Here's the relevant information that can be extracted from the provided text, modified to address the non-AI nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance |
|---|---|
| Intended Use (similar to predicate) | Treatment of fractures, fusions, and osteotomies of the radius and ulna. |
| Indications for Use (similar to predicate) | Treatment of fractures, fusions, and osteotomies of the radius and ulna. |
| Materials (similar to predicate) | Titanium alloy (ASTM F-136). |
| Design (fundamental scientific technology) (similar to predicate) | Midshaft Radius Plates and Midshaft Ulna Plates, multiple lengths and hole configurations. |
| Performance (Mechanical Testing) (equivalent to predicate) | Met requirements of ASTM F382 (Standard Specification and Test Methods for Metallic Bone Plates). |
| Sterility (similar to predicate) | Not explicitly detailed but stated as similar to predicate. |
| Packaging (similar to predicate) | Not explicitly detailed but stated as similar to predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a traditional medical device (bone plate system), not an AI/ML device that uses test sets or data provenance in the same way. The performance was demonstrated through mechanical testing.
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 information is not applicable. Ground truth establishment by experts is relevant for diagnostic or AI-driven devices. For a bone plate system, performance is assessed through standardized mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical trials or for evaluating human expert performance, not for the mechanical testing of a bone plate.
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
This information is not applicable. An MRMC study is relevant for diagnostic AI tools that assist human readers. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through standardized mechanical testing, specifically ASTM F382, which evaluates the physical properties and strength of the metallic bone plates. The goal is to demonstrate that the device performs equivalently to the predicate devices under these test conditions.
8. The sample size for the training set
This information is not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This device is not an AI/ML algorithm.
§ 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.