(86 days)
The N-Force Fixation System is intended for the fixation of bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver injectable bone void fillers to a surgical site.
The N-Force Fixation System includes fully and partially cannulated screws in various diameters and lengths, in both fenestrated and non-fenestrated options. The system also includes washers and accompanying instruments.
The N-Force Fixation System implants are made of titanium alloy.
This document is a 510(k) premarket notification for the InnoVision N-Force Fixation System. It establishes substantial equivalence to a predicate device, which means detailed studies proving device performance against specific acceptance criteria for a novel device are not typically included in these types of FDA submissions. Instead, the submission relies on demonstrating the new device is as safe and effective as a legally marketed predicate.
Therefore, the following information, if applicable, would be derived from the provided document, but it's important to understand that a 510(k) does not typically contain the level of detailed study information (e.g., sample sizes for test sets, expert qualifications, MRMC studies, ground truth details for training sets) that would be found in a De Novo submission or a PMA application for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to) | Reported Device Performance (Summary) |
|---|---|
| Predicate N-Force Fixation System (K102528, K132244) | Demonstrated substantial equivalence in: |
| - Indications | - Indications for use match predicate. |
| - Design | - Design similar, with fully/partially cannulated, fenestrated/non-fenestrated screws, washers, and instruments. |
| - Function | - Functions similarly for bone fixation and BVF delivery. |
| - Performance (Mechanical) | - Mechanical testing (static three-point bending, torsion, axial pull-out, insertion torque) demonstrated similar performance. |
| - Performance (BVF Injection) | - Bone void filler injection testing (injectability, void fill imaging, paste hardness, X-Ray diffraction, static extraction torque) demonstrated similar performance. |
| - Materials | - Implants made of titanium alloy, similar to predicate. |
| - Ability to deliver BVF to a surgical site | - Explicitly stated as equivalent. |
2. Sample size used for the test set and the data provenance
The document states "Testing performed on the N-Force Screw indicates that it is substantially equivalent to the predicate devices." However, it does not specify the exact sample sizes used for each type of mechanical or BVF injection test.
Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned in this 510(k) summary, as the focus is on laboratory-based mechanical and functional testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. Substantial equivalence for this device relies on mechanical and material testing, not on human interpretation of medical images or data requiring expert consensus for a "ground truth" as typically seen in AI/diagnostic device studies.
4. Adjudication method for the test set
This information is not applicable and not provided, as the testing involves objective mechanical and material properties rather than subjective interpretation requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical implant (bone fixation system), not a diagnostic device that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical implant, not an algorithm or AI system.
7. The type of ground truth used
For mechanical and material testing, the "ground truth" would be established by the physical properties and performance characteristics of the predicate device, as well as established engineering standards and specifications for medical implants. For example, for "static three-point bending," the ground truth would be the established maximum bending moment or deflection tolerance for the predicate, and against which the new device's performance is compared.
8. The sample size for the training set
This is not applicable as the document describes a physical medical device, not an AI or machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.