(343 days)
The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:
- · Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
- · Fusions of the joints and bone (hand, foot, long-bone)
- · Correction of bone or soft tissue deformities
- · Correction of segmental or non-segmental bone, soft tissue defects or bone loss
- · Neutralization of fractures stabilized with limited internal fixation
- · Adult and Pediatric subgroups except newborns
Revolution is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus.
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
A plating system consists of a stacked welded plate module and a footplate. These two plates are connected by four super-struts attached by the surgeon to give the best support for the patient. Once assembled, the module is attached to the patient's limb with half-pins or wires. The halfpins are threaded pins with a buttress thread form. Half pins come in three sizes, 4mm, 5mm, and 6mm. Half pins comes in 215mm overall length, but various thread lengths to encompass the size of the bone. Wires come In 1.8mm in diameter and come in 400mm overall lengths. They're meant for traction to the bone. These are inserted through or to the bone and attached to the frame to create a stable construction patient's limb thereby allowing the surgeon to correct or repair the patient's indications.
This document describes Revolution External Plating System, an external fixator. The following is an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Connector static axial grip testing | Not explicitly stated but implied to be sufficient for clinical use and substantially equivalent to predicates. | Results showed substantial equivalence to legally marketed predicate devices. |
| Connector static torsion grip testing | Not explicitly stated but implied to be sufficient for clinical use and substantially equivalent to predicates. | Results showed substantial equivalence to legally marketed predicate devices. |
| Ring static in-plane compression testing | Not explicitly stated but implied to be sufficient for clinical use and substantially equivalent to predicates. | Results showed substantial equivalence to legally marketed predicate devices. |
| Strut static axial compression testing | Not explicitly stated but implied to be sufficient for clinical use and substantially equivalent to predicates. | Results showed substantial equivalence to legally marketed predicate devices. |
| Construct dynamic axial compression testing | Not explicitly stated but implied to be sufficient for clinical use and substantially equivalent to predicates. | Results showed substantial equivalence to legally marketed predicate devices. |
2. Sample Size and Data Provenance
This document does not describe a clinical study involving human patients, but rather non-clinical mechanical performance testing. Therefore, there is no information on sample sizes for a test set in the context of human data or data provenance (e.g., country of origin, retrospective/prospective). The "test set" in this case refers to the physical devices tested.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is a mechanical performance study of a device, not a study requiring expert interpretation of data or images to establish ground truth.
4. Adjudication Method
Not applicable, as this is a mechanical performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes mechanical testing of a medical device, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, in the sense that the mechanical tests were performed directly on the Revolution External Plating System device itself, without human intervention in the device's function during the test. The "performance" being evaluated is the mechanical integrity and strength of the device.
7. Type of Ground Truth Used
The ground truth for this study is not clinical outcomes or expert consensus, but rather the physical properties and mechanical strength standards as defined by ASTM F1541 and compared against legally marketed predicate devices. The "truth" is whether the device can withstand specified mechanical stresses.
8. Sample Size for Training Set
Not applicable. This is not an AI/machine learning model where a "training set" of data is used. The "training" for this device would be its design and manufacturing process.
9. How Ground Truth for Training Set Was Established
Not applicable. As noted above, this is not an AI/machine learning context. The design of the device (if that were considered a 'training set') would be based on engineering principles, material science, and the existing predicate devices.
§ 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.