(257 days)
The Orthofix Galaxy Fixation System and is intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and all pediatric subgroups patients except newborns, as required.
The indications for use include:
- Open or closed fractures in long bones;
- Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
- Infected and aseptic non-unions;
- joint pathologies/injuries of upper and lower limbs such as:
- proximal humeral fractures; .
- intra-articular knee, ankle and wrist fractures; .
- Delayed treatment of dislocated and stiff elbows; .
- Chronic, persistent elbow joint instability; .
- Acute elbow joint instability after complex ligament injuries; .
- Unstable elbow fractures; .
- Additional elbow stabilization of post-operative unstable internal fixation. .
The Orthofix Galaxy Fixation System includes various frames, bars, clamps, accessories and instruments. The system is designed to be used with commercially available Orthofix pins. The clamps enable the frame to be coupled to bone by securing the pins/wires for the intended use.
The Galaxy Fixation System can be combined to construct different frame configurations that have been shown to be MR conditional in 1.5T and 3T MR environment. The system consists of various modules which are designed to be applied in different anatomical sites of the upper and lower limb as well as the pelvis and allow the surgeon to:
- Position screws where the condition of the bone and soft tissues permits
- Reduce the fracture in order to restore alignment
- Stabilize the fracture safely
The Orthofix Galaxy Fixation System is a medical device and, as such, its acceptance criteria and the study proving it meets these criteria are based on non-clinical laboratory testing rather than human clinical studies with performance metrics like sensitivity, specificity, or reader improvement.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily centered around demonstrating substantial equivalence to predicate devices through mechanical performance and safety in a Magnetic Resonance (MR) environment.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | The Orthofix Galaxy Fixation System must demonstrate mechanical strength and performance that is equivalent to or better than the predicate devices. This includes: |
- Static testing on Connector
- Static testing on Joint
- Static testing on Construct
- Static testing on Ring Segment
- Multi-cycle testing on Construct (Fatigue tests on Configurations)
- Force and Torque Testing | Testing in accordance with ASTM 1541-02 shows the mechanical strength of the Galaxy Fixation system to be equivalent or better than the predicate devices. Specific numerical results are not provided in this summary but the statement confirms the device met this criterion. |
| MR Environment Safety | The Orthofix Galaxy Fixation System must demonstrate safety and compatibility in a Magnetic Resonance environment, specifically: - Radio Frequency Heating Testing
- Artifact Testing
The system must be "MR Conditional" in 1.5T and 3T MR environments. | The Galaxy Fixation System can be combined to construct different frame configurations that have been shown to be MR conditional in 1.5T and 3T MR environment. Testing was performed to assess Radio Frequency Heating and Artifacts, with the implication that the results confirmed MR conditional compatibility under predetermined conditions, similar to one of the predicate devices (Hoffmann 3 Modular External Fixation System, K111786). |
2. Sample Size Used for the Test Set and Data Provenance
For a medical device like the Orthofix Galaxy Fixation System, the "test set" refers to the specific configurations and components of the device that underwent non-clinical laboratory testing.
- Sample Size: The document does not specify an exact numerical sample size for the mechanical and MR environment tests (e.g., "N units tested for static strength"). Instead, it states that "the Orthofix Galaxy Fixation System" underwent testing, implying a representative selection of various frames, bars, clamps, and accessories.
- Data Provenance: The testing was "non clinical laboratory testing" performed by the manufacturer, Orthofix Srl, likely at their facilities or a contracted testing lab. The location is Italy (Bussolengo (VR)), as indicated by the submitter's address. This is inherently prospective for the device being submitted, as the tests were conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this 510(k) submission. For mechanical and MR safety testing of a physical medical device, "ground truth" is established by adherence to recognized preclinical testing standards (e.g., ASTM 1541-02) and objective measurements using calibrated equipment, not by human expert consensus or interpretation of images. The performance is objectively measured against engineering specifications and predicate device performance.
4. Adjudication Method for the Test Set
This question is not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment (e.g., radiology reads) to resolve discrepancies among experts.
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 is relevant for diagnostic imaging devices or AI tools where human readers interpret medical images. The Orthofix Galaxy Fixation System is an external fixation device, and its evaluation focuses on mechanical and safety performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Orthofix Galaxy Fixation System is a physical medical device, not an algorithm or AI system. Its "performance" is inherently standalone in the sense that the device itself is tested for its physical properties and interactions with an MR environment, without human "in-the-loop" performance as a diagnostic aid.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Orthofix Galaxy Fixation System is established by:
- Engineering Specifications and Standardized Test Methods: Adherence to established industry standards like ASTM 1541-02 for mechanical testing.
- Objective Measurements: Direct measurement of forces, torques, fatigue cycles, RF heating, and artifact size using specialized testing equipment.
- Comparison to Predicate Devices: The measured performance of the device is compared directly against the known performance of legally marketed predicate devices, with the ground truth being "equivalent or better" performance.
8. The Sample Size for the Training Set
This question is not applicable. The Orthofix Galaxy Fixation System is a physical medical device, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
§ 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.