(36 days)
The AxSOS 3 Ti Locking Plate System Line Extension is intended for long bone fracture fixation. Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- Non-unions and malunions .
- Normal and osteopenic bone .
- . Osteotomies
This Special 510(k) submission is being supplied to the U.S. FDA to introduce additional screw types and drive features to the currently marketed AxSOS 3 Ti Locking Plate System (K123964). The additional screw types will include: 3.5mm and 4.5mm Cortex Shaft screws, 4mm and 6mm Cancellous partially and fully threaded screws. The subject device is an internal fixation device that consists of monoaxial locking plates and various types of screws to fit different types of fractures in the tibia and femur. The subject device consists of anatomically contoured Femur and Tibia plates and various types of screws which were previously cleared in K123964. All components are manufactured from Titanium alloy per ASTM F136. The Distal Lateral Femur plates are fixed to the femur using 5mm locking screws or non-locking screws with either or 4.5mm Cortex and 6mm cancellous non-locking screws. The Proximal Lateral Tibia plates are fixed to the tibia using 4mm locking screws with either or 3.5mm Cortex and 4mm cancellous non-locking screws.
The provided text describes a 510(k) summary for the AxSOS 3 Ti Locking Plate System Line Extension, a medical device for long bone fracture fixation. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not applicable or available in this type of regulatory submission.
The document states that a non-clinical test was performed, which involved a risk analysis according to ISO 14971. This analysis aimed to demonstrate that the new device components did not present a "new worst case" and that the same verification and validation methods applied to the predicate devices were used. It concluded that the subject components met performance requirements and were as safe and effective as the predicate devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (relative to predicate devices) | The risk analysis demonstrated that the subject device did not present a new worst case. The same verification and validation methods were applied as to predicate devices. The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not applicable/Available. The submission describes a non-clinical risk analysis and verification/validation methods rather than a clinical test set with human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Available. Ground truth as typically understood for clinical performance studies (e.g., diagnostic accuracy) is not established or discussed in this non-clinical submission.
4. Adjudication method for the test set:
- Not applicable/Available. No clinical test set requiring adjudication is described.
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:
- Not applicable. This submission is for a medical implant (bone fixation system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not a standalone algorithm.
7. The type of ground truth used:
- Not applicable. The "ground truth" in this context is based on engineering performance requirements and safety analyses as compared to predicate devices, not clinical outcomes or expert consensus for diagnosis.
8. The sample size for the training set:
- Not applicable. There is no "training set" as understood in machine learning or clinical study design, given this is an implant device verification.
9. How the ground truth for the training set was established:
- Not applicable. See 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.