(447 days)
Ankle Arthrodesis, Tibio-talo-calacaneal Arthrodesis
The Vilex FUZETM is a single-piece intramedullary nail fixed to the tibia and foot with locking cross screws for fusing the ankle joint(s). The FUZETM is a straight cannulated metallic implant offered in five diameters and various lengths in either 316L VM (ASTM 138) stainless steel or Ti6Al4V titanium alloy (ASTM 136). The FUZETM System is a modular system consisting of the implant, locking screws, and instrumentation for fixation. The screws, (offered in one diameter and various lengths), are manufactured from identical materials (either stainless steel or titanium alloy, matching the implant). The targeting device is radio translucent, designed to lock into the FUZETM for the correct insertion of the locking screws. The system also includes drills, reamers, screwdrivers, guide wires and Steinman pins.
Here's an analysis of the provided 510(k) summary for the FUZE®: Intramedullary Arthrodesis Nail System, focusing on acceptance criteria and the supporting study, based only on the information provided in your input:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., tensile strength, fatigue life thresholds). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is framed in terms of achieving this equivalence and demonstrating mechanical integrity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Design features comparable to predicate devices. | "The design features of the FUZETM Intramedullary Arthrodesis Nail System are substantially equivalent to the design features of other predicate devices previously cleared for market. The methods used to establish equivalence are indications for use, material of construction, sizes, hole locations, and shape." |
| Mechanical Integrity: Sufficient for the intended application. | "Engineering analysis, cadaver, sawbones, and components tests confirm that the design possesses the mechanical integrity necessary for this application and implant can compress the tibi-talo-calcaneal joints." |
| Safety and Effectiveness: Adequately supported. | "The safety and effectiveness of the FUZETM is adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." (This is a summary statement, not a specific performance metric, but it encapsulates the overall goal of the submission). |
| Material Compatibility: Suitable for human implanting. | "Material: Titanium Ti6Al4V, ASTM 136 or stainless steel alloy 316L ASTM 138, suitable for human implanting" (This is a material specification that inherently implies suitability for implantation, which is a form of acceptance). |
| Intended Indications for Use: Ankle Arthrodesis, Tibio-talo-calcaneal Arthrodesis. | The device is indicated for these uses, and the equivalence argument implicitly supports its ability to perform these functions similarly to predicates. The performance is that it can be used for these indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a numerical count of cadavers, sawbones, or specific test pieces. The summary mentions "cadaver, sawbones, and components tests."
- Data Provenance: The nature of the tests (engineering analysis, cadaver, sawbones, and components tests) suggests the data is likely prospective in the sense that these tests were conducted specifically for this submission to evaluate the device. The geographical origin of the data is not specified but would typically be from the manufacturer's testing facilities or contract labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the summary. The "tests" mentioned (engineering, cadaver, sawbones, components) are mechanical and material performance tests, where "ground truth" would be established by scientific measurement and engineering principles rather than expert clinical consensus in the way it applies to diagnostic devices evaluating images/data.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., reading medical images) to resolve discrepancies among multiple expert opinions in establishing a ground truth. The tests described are engineering and material performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases, and the AI's impact on their performance is evaluated. The FUZE system is an implantable orthopedic device.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study (algorithm only) was not done. This concept is also primarily applicable to AI/ML diagnostic algorithms. The FUZE is a physical medical device; its performance is evaluated through mechanical testing, material analysis, and comparison to predicate devices, not through an "algorithm only" study.
7. Type of Ground Truth Used
The "ground truth" in this context is established by:
- Engineering principles and measurements: For mechanical integrity (e.g., strength, stiffness, fatigue).
- Material specifications: Conformance to ASTM standards for Titanium and Stainless Steel.
- Comparison to predicate devices: Establishing that its design features (indications, materials, sizes, hole locations, shape) are substantially equivalent.
- Biomechanical performance: Demonstrated through cadaver and sawbones tests for its ability to compress tibi-talo-calcaneal joints.
8. Sample Size for the Training Set
Not Applicable. The FUZE system is a physical orthopedic implant, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, there is no corresponding ground truth to establish for it.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.