(115 days)
The Medline Unite® Mini Plates and Screws are in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients.
Examples include:
- · Metatarsal or metacarpal fractures and osteotomies
- · Cuboid fractures
- Navicular fractures
- Talar neck fractures
- · Jones and avulsion fractures of the 5th metatarsal
- · Lesser metatarsal shortening osteotomies (i.e. Weil Osteotomies)
- ·Phalanges fractures and osteotomies
The Medline Unite® Mini Locking and Non-Locking Screws are indicated for use with the Medline Unite® Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The Medline Unite® Mini Plates and Screws are manufactured from Titanium Alloy. The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.0mm, 2.4mm and 2.7mm diameter locking and non-locking screws to be used with the polyaxial locking holes and compression slots included in the plates as well as 4.0mm cannulated screws to be used with the hook plate. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits.
This document is a 510(k) premarket notification for a medical device, specifically bone fixation plates and screws. It details an equivalency comparison to a predicate device. As such, it does not contain information about AI models, algorithms, or typical machine learning study designs.
Therefore, most of the requested information (sample sizes for training/test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this document.
Here's what can be extracted based on the document's content:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than setting specific acceptance criteria for a new, AI-driven performance metric. The acceptance criteria implicitly involve demonstrating equivalent mechanical properties to the predicate device. The reported device performance refers to the results of these equivalency tests.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Plates: | ||
| Single Cycle 4-Point Bend | Bending stiffness of proposed device equivalent to predicate device (per ASTM F382-17) | "The results from single cycle 4-point bend test demonstrate that the Medline Unite® Mini Plates and the predicate Wright Medical ORTHOLOC® 2.0/2.4 plates are substantially equivalent in 4-point static bend testing." |
| Screws: | ||
| Static Axial Pullout | Axial pullout strength of proposed device equivalent to predicate device (per ASTM F543-17) | "The results from the axial pullout test demonstrate that the Medline Locking and Non-locking Screws and the predicate Wright Medical ORTHOLOC® 2.0/2.4 Locking and Non-locking Screws are equivalent in axial pullout." |
| Static Torsion | Torsional strength of proposed device equivalent to predicate device (per ASTM F543-17) | "The results from the static torsional testing show that the Medline Locking and Non-locking Screws and the predicate Wright Medical ORTHOLOC® 2.0/2.4 Locking and Non-locking Screws are equivalent in torsional strength." |
Since this 510(k) is for a traditional medical device (metallic bone fixation appliances) and not an AI/ML powered device, the following points are not applicable to the provided text.
2. Sample size used for the test set and the data provenance: Not applicable - this is a mechanical testing report, not a study of an AI algorithm on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable - ground truth in this context is based on mechanical engineering standards and measurements, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable - no human interpretation or adjudication is involved in these mechanical tests.
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 not an AI-powered device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable - this is a traditional medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is typically the measured physical properties of the materials and devices, determined by standardized laboratory methods (ASTM standards in this case).
8. The sample size for the training set: Not applicable - no AI training set is involved.
9. How the ground truth for the training set was established: Not applicable - no AI training set is involved.
§ 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.