(241 days)
Synthes External Fixation Devices are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
The Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for:
· Preliminary fixation before ORIF
· Unstable fractures of the distal radius (both intra- and extra-articular)
· Open and/or comminuted bilateral fractures
· Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement
· Fracture dislocations
· Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)
· Pediatric open fractures with bone loss and osteotomies
The Synthes Large External Fixation Systems is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
• Stabilization of soft tissues and fractures
• Poyltrauma/multiple orthopedic trauma
• Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
• Arthrodeses and osteotomies with soft tissue problems; failures of total joints
• Neutralization of fractures stabilized with limited internal fixation
• Non-unions/septic non-unions
• Intra-operative reductions/stabilization tool to assist with indirect reduction
• Unilateral rectilinear bone segment transport or leg lengthening
Synthes Reprocessed External Fixation Devices consist of various clamps, rods, bars and rings which are used to construct an external fixation frames in the treatment of various types of fractures.
This document describes the acceptance criteria and study proving the "Synthes Small and Large External Fixation Systems - MR Conditional" devices meet these criteria for safe use in an MRI environment.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Displacement | Meets requirements in ASTM F2052 | Met the requirements |
| Torque | Meets requirements in ASTM F2213 | Met the requirements |
| RF Heating | Acceptable heating in accordance with ASTM F2182 | Shown to have acceptable heating |
| Image Artifact | Determined through testing in accordance with ASTM F2119 | Determined through testing in accordance with ASTM F2119 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of individual devices or configurations) used for the testing. It mentions "The devices" (plural) were tested, implying multiple units or configurations were evaluated.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The study is a performance study for medical devices in an MR environment, not a diagnostic study requiring expert ground truth for interpretation. The acceptance criteria are based on established ASTM standards for MR compatibility, which define objective, measurable physical parameters.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective human interpretation of data for ground truth establishment. This study relies on objective physical measurements against predefined engineering standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is not relevant for testing the MR compatibility of physical implants. The study is focused on the physical interaction of the device with an MRI field.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was effectively done. The testing described (displacement, torque, RF heating, image artifact) evaluates the intrinsic physical properties of the devices themselves in an MRI environment, independent of human interaction or interpretation beyond setting up the test and recording measurements. There is no "algorithm" in the context of this device; it is a physical implant.
7. The Type of Ground Truth Used
The "ground truth" for this study is the set of established, quantifiable physical limits and measurement methodologies defined by the ASTM standards (ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) for assessing MR compatibility of medical implants. The device performance is compared directly to these objective standards.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a performance study of physical devices, not a machine learning model or diagnostic algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set in this context.
§ 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.