(164 days)
The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Frontier Devices FUSIO Screw Fuze System consists of titanium bone screws of 7mm, 9.5mm, and 11mm diameter of various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw. The screws are made from titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.
The provided document describes the Frontier Devices FUSIO Screw Fuze System, a medical device for sacroiliac joint fusion. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific acceptance criteria in the typical sense of a clinical trial or algorithm performance study.
Instead, the "acceptance criteria" here relate to demonstrating that the new device performs similarly in mechanical tests to legally marketed predicate devices, thereby meeting the FDA's requirements for 510(k) clearance.
Here’s a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Insertion Torque: | FUSIO Screw Fuze System: |
| - Comparable insertion torque to predicate screws. | - Tests showed "similar results as predicate screws" (Globus and X-Spine) into Grade 15 polyurethane foam blocks. Peak torque measured after 4 revolutions was recorded and compared using mean torque values with standard deviations. "The insertion torque measurements... support the fact that the Frontier Devices FUSIO Screw Fuze System screws are substantially equivalent to predicate screws." |
| Mechanical Properties (Cross-Sectional): | FUSIO Screw Fuze System: |
| - Comparable ability to handle forces and stresses. | - Engineering analysis (using SolidWorks) of the worst-case FUSIO Screw Fuze screw at the cross-section (middle of the screw) determined it could "handle forces and associated stresses similarly" to the legally marketed X-Spine Silex screw. |
| Thread Properties (Projected Thread Engagement Area): | FUSIO Screw Fuze System: |
| - Comparable thread engagement area. | - SolidWorks was used to calculate the projected threaded area, showing "substantial equivalence" to the predicate devices. |
| Cyclic Bending Endurance: | FUSIO Screw Fuze System: |
| - Meet pass-fail criteria for endurance under cyclic loading. | - Cyclic bending tests on the worst-case FUSIO Screw Fuze screw produced an endurance curve "which yielded acceptable factors of safety for the force and moment." The system "successfully passed the pass-fail criteria." |
| Material Composition: | FUSIO Screw Fuze System: |
| - Made from titanium alloy (ASTM F136). | - The screws are made from titanium alloy, Ti-6Al-4V, conforming to ASTM F136. This is consistent with predicate devices. |
| Dimensions (Diameter and Length): | FUSIO Screw Fuze System: |
| - Similar diameters and lengths. | - Available in 7mm, 9.5mm, and 11mm diameters of various lengths, which are "similar to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of individual screws tested for each assessment (insertion torque, cyclic bending). The document mentions "representative screws" for insertion torque and "the worst-case FUSIO Screw Fuze screw" for engineering analysis and cyclic bending tests. This suggests a limited number of physical samples for mechanical testing, characteristic of device design verification.
- Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory mechanical testing of the FUSIO Screw Fuze System and comparative measurements/analyses against predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This question is not applicable to this type of device submission. There is no "ground truth" to be established by medical experts for mechanical performance tests of bone screws. The "ground truth" here is the objective physical measurement of mechanical properties.
4. Adjudication Method
- Not applicable. There is no adjudication required for laboratory mechanical test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a mechanical device, not an imaging or diagnostic AI device. MRMC studies are not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a physical medical device (bone screw), not an algorithm or AI.
7. The Type of Ground Truth Used
- Objective Mechanical Measurements and Engineering Analysis: The "ground truth" for the performance tests consists of:
- Direct physical measurements (e.g., peak insertion torque, force sustained during cyclic loading).
- Engineering calculations and simulations (e.g., stress analysis using SolidWorks, projected threaded area).
- Comparison against established ASTM standards (ASTM F136 for material).
- Comparison against the known performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set. The design of the device would be informed by engineering principles, material science, and the existing predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.