(61 days)
The OrthoHelix Edgelock Plate System is indicated for fixation of fractures, fusions and osteotomies of the small bones in the hand, wrist, foot and ankle in pediatric and adult patients.
The OrthoHelix Edgelock Plate System is a set of metallic, implantable, bone fixation plates. All plates are made from implant grade titanium alloy.
This is a 510(k) summary for a medical device (Edgelock Plate System) and does not contain information about an AI/ML powered device or a study involving human readers or ground truth in the context of diagnostic performance. Therefore, most of the requested fields cannot be filled.
Here's what can be extracted:
Device Name: Edgelock Plate System
Device Description: The OrthoHelix Edgelock Plate System is a set of metallic, implantable, bone fixation plates, made from implant grade titanium alloy.
Intended Use/Indications for Use: The Edgelock Plate System is indicated for fixation of fractures, fusions and osteotomies of small bones in the hand, wrist, foot and ankle in pediatric and adult patients.
Study Type: Substantial Equivalence Study
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Edgelock Plate System) for intended use. | Finite Element Analysis and mechanical testing confirm that the implants within the Edgelock Plate System are substantially equivalent to its predicate devices. The device meets the specified requirements for its intended use. |
| No new issues of safety or efficacy raised. | No new issues of safety or efficacy have been raised. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The study was a non-clinical evaluation (Finite Element Analysis and mechanical testing) comparing the device to its predicates.
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)
Not applicable. The study involved engineering analysis and mechanical testing, not ground truth established by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical study.
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 device is a bone fixation plate, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" equivalent here would be engineering standards and performance characteristics for bone fixation plates, established through Finite Element Analysis and mechanical testing, and comparison to predicate devices, rather than medical ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, 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.