(211 days)
Smith&Nephew Modular Rail System:
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudarthrosis of long bones
- Limb lengthening by distraction
- Correction of bony or soft tissue deformities
- Infected fractures
- Nonunions
Smith & Nephew Taylor Spatial Frame Fixator:
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudarthrosis of long bones
- Limb lengthening by distraction
- Correction of bony or soft tissue deformities
- Joint arthrodesis
- Infected fractures
- Nonunions
Smith & Nephew JET-X Fixator:
- Open and closed fractures fixation
- Bony or soft tissue deformities
- Infected fractures
- Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius
Smith & Nephew Ilizarov System:
- Fractures and disease which generally may result in ioint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudarthrosis of long bones
- Limb lengthening by distraction (not applicable for use with COMPASS Universal Hinge)
- Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge)
- Joint arthrodesis (not applicable for use with COMPASS Universal Hinge)
- Infected fractures
- Nonunions
The Smith & Nephew External Fixation Systems consist of the TAYLOR SPATIAL FRAME Fixator, ILIZAROV External Fixator, JET-X Fixator and the Smith & Nephew Rail System. In general, each system consists of a unique combination of pins, bars, clamps, rings, struts, rods and/or rails to achieve fixation of a bone or joint. The JET-X system can be used with various clamps, pins, and carbon fiber bars to provide versatility in achieving fixation. The JET-X MINI system utilizes a smaller subset of components from the JET-X system. The MRS consists of a combination of pins, modular rail segments (linear or arcs), clamps, and distraction/compression device(s) to provide fixation. The TSF assemblies generally utilize 2-3 rings (half ring, 2/3 ring, full ring, and/or foot ring) or plates (U-plate), as well as struts to provide the framework for fixation. A series of rods, pins, and wires are then used to provide stability and fixation to the bone. The ILIZAROV system generally implements thin wire fixation alone or as an adjunct to internal fixation. Like the TSF, the ILIZAROV system contains a frame that consists of a combination of rings and rods, while pins and wires provide fixation of the frame to the bone.
This document is a 510(k) premarket notification for Smith & Nephew's Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, and Other External Fixation systems. The primary purpose of this submission is to add MR safety information to the labeling and update indications for use and package inserts due to European MDR related changes.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test Standard) | Device Performance |
|---|---|
| Magnetically induced displacement force (ASTM F2052) | Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits) |
| Magnetically induced torque (ASTM F2213) | Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits) |
| Radiofrequency (RF) induced heating (ASTM F2182) | Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits) |
| MR image artifact (ASTM F2119) | Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits) |
2. Sample size used for the test set and the data provenance:
The document states that "MRI compatibility testing/assessment was conducted." However, it does not specify the sample size for the test set (number of devices tested for MRI compatibility). The data provenance is not explicitly mentioned in terms of country of origin, but the testing was conducted to FDA guidance, suggesting a U.S. regulatory context. It is a prospective assessment of the device's MR safety characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For MRI compatibility testing, ground truth is typically established by comparing test results against established safety limits and standards (e.g., maximum temperature increase, allowable displacement). This typically involves engineering and physics experts rather than medical experts for ground truth establishment.
4. Adjudication method for the test set:
This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data, which is not directly applicable to a performance study for MRI compatibility of an external fixator. The assessment relies on meeting predefined technical standards.
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 is not applicable to this submission. This submission is for physical devices (external fixators) and their MRI compatibility, not for an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this submission as it concerns physical medical devices, not algorithms or AI.
7. The type of ground truth used:
The ground truth used for this study is based on established scientific and regulatory standards for MRI compatibility. Specifically, the document references:
- FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," December 11, 2014.
- International standards: ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119.
These standards define the acceptable limits for various magnetic resonance interactions (displacement, torque, heating, artifact) for medical implants.
8. The sample size for the training set:
This is not applicable. This submission is for the physical performance testing of medical devices, not for a machine learning or AI model that requires a training set. The devices being cleared are substantially equivalent to existing predicate devices, with the primary new information being MR safety data.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for an AI model mentioned in this submission.
§ 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.