(49 days)
The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.
Indications include:
- compression fractures .
- intra-articular and extra-articular fractures ●
- . displaced fractures
Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.
This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Distal Radius Plating, which was cleared in K04022, as the Universal Distal Radius System. The subject plate consists of distal radius fragment specific plates (lateral and dorsal medial). The subject components will be available sterile and non-sterile. The VariAx Distal Radius Plating System consists of multiple internal fixation plates in varying lengths and widths. The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, K132502 and K140769.
The provided document describes a 510(k) submission for a line extension to a bone plating system, specifically the VariAx Distal Radius Plating System. This type of submission is for medical devices that are "substantially equivalent" to predicate devices already on the market. Therefore, the "acceptance criteria" and "study" are focused on demonstrating this substantial equivalence through non-clinical testing, rather than a clinical study establishing efficacy or diagnostic performance as would be expected for an AI/ML device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Device) | Reported Device Performance (Reference Standard) |
|---|---|
| Mechanical Performance: Meet "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008" for the worst-case subject plates. | The non-clinical laboratory testing "[demonstrated] that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the TriMed Bone Plates (K060041)." |
| Intended Use Equivalence: Same intended use as predicate devices. | The device is intended for internal fixation of small bone fractures, primarily including distal radius fractures, similar to the TriMed Wrist Plates (K060041). |
| Operational Principles Equivalence: Similar operational principles for use. | The device is similar to the TriMed Wrist Plates (K060041) in regards to operational principles for use for internal fixation for fractures of the bones in the distal radius. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document mentions "worst case subject plates" were tested. It does not specify the exact number of plates or samples tested, but implies that representative samples deemed "worst case" were selected for mechanical testing.
- Data Provenance: The testing was "non-clinical laboratory testing." The document does not specify the country of origin of the data beyond implying it was conducted to ASTM standards, which are international standards. The testing was retrospective in the sense that it evaluates the manufactured product against established standards and a predicate device, not in the context of a prospective patient study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for this device's acceptance is based on engineering standards (ASTM F382-99:2008) and comparison to a legally marketed predicate device, not on expert medical consensus on diagnostic outcomes or interpretations.
4. Adjudication Method for the Test Set
This is not applicable. There was no expert-based ground truth to adjudicate for this type of submission. The performance was assessed against engineering 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. This submission is for a physical medical device (bone plating system), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is:
- Engineering Standards: Compliance with "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."
- Predicate Device Performance: Demonstrating substantial equivalence to the mechanical, intended use, and operational principles of the TriMed Wrist Plates (K060041).
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Manufacturing processes are validated, but this isn't referred to as a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8. There is no training set mentioned in the context of an AI/ML algorithm.
§ 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.