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510(k) Data Aggregation
(100 days)
The Orthofix Contours VPS III is intended for volar fixation of fractures and osteotomies involving the distal radius.
The Contours VPS is an anatomically contoured, delta-shaped plate intended for volar applications to the distal radius. The Contours VPS features an angled head with two rows of holes for placement of screws distally on the radius to secure bone fragments and provide stabilization. If a bone graft is required, access to the site is made possible by the opening in the plate that spans from the plate head to the distal portion of the shaft that may also be utilized for screw placement. The shaft of the Plate is placed proximally on the distal radius and offers a variety of K-wire and screw placement options for secure fixation to the external surface of the bone. The device provides the stabilization and fixation necessary in the treatment of distal radius fractures and osteotomies.
This document describes the Contours VPS III Volar Plating System, a bone plate intended for volar fixation of fractures and osteotomies involving the distal radius. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a bone plate for orthopedic fixation), the primary acceptance criteria revolve around biomechanical performance and material properties, demonstrating it is at least as safe and effective as a predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biomechanical Strength | The modified plates must meet or exceed the criteria for mechanical strength and stiffness of the predicate device when tested in uni-axial compression. (Implied: The device must be strong and stiff enough to stabilize distal radius fractures). | "The results of the testing demonstrated that the Contours VPS exceeded all mechanical testing criteria." (This explicitly states the device exceeded the criteria, implying successful meeting of acceptance standards). |
| Material Composition | The device material must be biocompatible and meet established standards for implantable titanium alloys. (Implied: Material should be safe and suitable for long-term implantation). | "The Contours VPS III plates and screws are made from titanium alloy, Ti6AL-4V ELI conforming to ASTM F136." (Conforming to ASTM F136 indicates it meets recognized material standards for medical implants). |
| Substantial Equivalence | Demonstrate substantial equivalence in design, function, and intended use to the predicate device (Orthofix Volar Distal Radial Plate, K042766). | The conclusion states: "Based upon the results of biomechanical testing, the modified Contours VPS III plates and expanded range of sizes is substantially equivalent to the Orthofix Volar Distal Radial Plate. The Contours VPS III has the mechanical properties needed to perform its indications for use and is considered to be substantially equivalent to the predicate device in design, intended use, material and function." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the test set: Not explicitly stated as a number of devices. The document mentions "the modified Contours VPS III plates." It refers to "testing" in the context of biomechanical properties. For mechanical testing, this typically involves a specified number of samples (e.g., n=5 or n=10) per test condition to achieve statistical significance. However, the exact count is not provided.
- Data Provenance: The study is reported internally by the manufacturer, Orthofix Inc. There's no mention of country of origin of the samples or if the data is retrospective or prospective, as it's a preclinical biomechanical testing study, not a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a biomechanical study comparing physical properties of a device, not a study evaluating human interpretation of medical data where expert radiologists or clinicians would establish ground truths. The "ground truth" here is the established mechanical properties and performance standards of the predicate device and relevant ASTM standards.
4. Adjudication Method for the Test Set
Not applicable for a biomechanical testing study. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data (e.g., imaging) and need a consensus to establish ground truth or resolve discrepancies.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical implant (bone plate), not an AI/software device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this preclinical study is primarily based on:
- Established mechanical properties and performance of the predicate device: The Contours VPS III was tested against the "same criteria for mechanical strength and stiffness as the predicate device."
- Industry consensus standards: The material conformity to "ASTM F136" is a standard ground truth for implant materials.
8. The sample size for the training set
Not applicable. This is a biomechanical testing study for a physical device, not an AI/machine learning study that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of study.
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