(78 days)
The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- Evans lengthening osteotomies
The Trigon Ti wedges are intended for use with ancillary fixation.
The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.
This document describes the Nvision Biomedical Technologies, Inc. Trigon HA Stand-Alone Wedge Fixation System, which is intended for internal bone fixation for bone fractures or osteotomies in the foot, specifically Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. It is not intended for use in the spine.
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1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not specify explicit quantitative acceptance criteria for device performance in the same way a clinical trial would for a new drug or diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "acceptance criteria" are implicitly met if the test results demonstrate equivalence and do not raise new issues of safety or efficacy.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compression performance: Demonstrate mechanical integrity and resistance to compression forces. | Testing performed per ASTM F2077. The submission states: "The results of these tests indicate that the Trigon™ HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices." (Page 5) The conclusion reiterates this: "Based on the testing performed, including compression, expulsion, and engineering analysis, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Trigon™ HA Stand-Alone Wedge Fixation System are assessed to be substantially equivalent to the predicate devices." (Page 5) |
| Expulsion performance: Demonstrate resistance to expulsion under relevant forces. | Testing performed (expulsion). The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Screw mechanical strength: Ensure the ancillary screws possess adequate strength. | Engineering analysis performed. The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Screw pullout strength: Ensure the ancillary screws maintain adequate fixation within the bone/wedge. | Engineering analysis performed. The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Material Equivalence (HA PEEK vs. PEEK): Demonstrate that the use of HA PEEK does not negatively impact equivalence compared to predicates made of standard PEEK. | "Trigon™ wedges are manufactured from HA PEEK while the primary predicate is manufactured from standard PEEK, however testing, analysis, and comparison to reference devices also manufactured from HA PEEK demonstrated that this does not negatively impact equivalence." (Page 5) This is a specific point of comparison where the "performance" is the demonstration that changing a material property does not lead to a negative impact on equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical (bench) testing, not human studies or clinical trials with test sets involving patients.
- Sample size: The document does not specify the exact number of samples (e.g., number of wedges or screws) used for each non-clinical test (compression, expulsion, screw strength/pullout). It only lists the types of tests performed.
- Data provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as these are bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a 510(k) submission for a medical device cleared through substantial equivalence based on non-clinical (bench) testing, not a diagnostic algorithm requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
Not applicable for a non-clinical device submission based on bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool where human reader performance would be evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, it does not involve algorithms or AI.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by the objective measurements and engineering standards (e.g., ASTM F2077 for compression) against which the device performance is measured to demonstrate substantial equivalence to predicate devices. It is thus engineering and mechanical testing standards.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a mechanical implant.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for it. The submission focuses on demonstrating equivalence of the mechanical properties of a new device to existing predicate devices.
§ 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.