(79 days)
The Construx External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.
The Construx External Fixation System consists of a central body, and several other components that can be used to create an external fixation frame. These components include:
- Male Stem Assembly
- Aluminum Ankle Assembly
- Carbon Ankle Assembly
- Carbon Straight Clamp Assembly
- Aluminum Male Straight Clamp
- Aluminum Female Straight Clamp
- Aluminum T-clamp
- Aluminum Angular Hinge Clamp
- Aluminum Ring Adapter
These components can be used with the DFS Bone Screws, and other components of the DFS Standard Fixator, DFS Ring and Vision External Fixation Systems.
The presented document is a 510(k) Summary for the Construx External Fixation System, which is a medical device for bone fixation. The document details the device description, indications for use, and a summary of performance data. However, the available text does not contain the specific acceptance criteria or an in-depth study report that would allow for a detailed answer to all parts of your request regarding AI/algorithm performance.
Here's what can be extracted and inferred from the provided text regarding the device's performance assessment, along with the information that is not present:
Acceptance Criteria and Study for Construx External Fixation System (Non-AI Device)
The Construx External Fixation System is a mechanical device, not an AI/algorithm. Therefore, the questions related to AI performance, such as human reader improvement with AI, standalone algorithm performance, training data, and expert ground truth for AI models, are not applicable to this document. The "Performance Data" section solely discusses mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established by Predicate Devices) | Reported Device Performance |
|---|---|
| Met for Static Testing (Assumed, based on text) | New Construx components met the established acceptance criteria set by the predicate devices. |
| Met for Fatigue Testing (Assumed, based on text) | New Construx components met the established acceptance criteria set by the predicate devices. |
- Note: The specific numerical values or qualitative descriptions of the acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the exact performance results are not detailed in this summary document. The document only states that the new components met the established criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Mechanical testing was performed on the Construx External Fixation System. Static and fatigue testing was performed on the new Construx components assembled as external fixation constructs."
- Sample Size for Test Set: Not specified. The number of constructs or individual components tested is not provided.
- Data Provenance: The nature of mechanical testing generally means the "data" is generated in a lab setting, not typically originating from a country or being retrospective/prospective in the way clinical data would be.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable to mechanical testing of a physical device. Ground truth for mechanical testing is based on engineering specifications and physical measurements, rather than expert clinical consensus.
4. Adjudication Method for the Test Set
- This question is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation or clinical data, not for objective mechanical performance.
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 question is not applicable. The Construx External Fixation System is a physical medical device, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The Construx External Fixation System is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications and established performance benchmarks derived from the predicate devices. For mechanical testing, this typically involves stress, strain, displacement, and cycle count measurements against pre-defined limits.
8. The Sample Size for the Training Set
- This question is not applicable. Mechanical testing does not typically involve a "training set" in the context of machine learning or algorithms. The "training" for such a device would be the design and manufacturing process, optimized based on engineering principles and prior device data.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reasons as #8. The "ground truth" for the design and manufacturing would be based on biomechanical principles, material science, and regulatory requirements, informed by the performance of predicate devices.
Summary of Missing Information:
The provided 510(k) summary is a high-level overview. For a comprehensive understanding of the acceptance criteria and study, one would typically need access to the full test report, which would detail:
- Specific test methods (e.g., ASTM standards referenced).
- Exact load conditions, displacement limits, and cycle counts for static and fatigue tests.
- The number of samples tested for each configuration.
- The actual measured performance values compared against the criteria.
- Detailed information about the predicate device's performance data that established these criteria.
§ 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.