(77 days)
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.
RCI Fixation Screws are rounded head interference screws which include diameters from 7 to 9 mm and a range of lengths from 25 mm to 50 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI screw.
The provided text describes a 510(k) submission for the "RCI Fixation Screws." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study for an AI/ML device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory submission. The document details bench testing, which is a different type of performance evaluation.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable fixation strength | Found to have suitable fixation strength for use as interference screws (via bench testing) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document describes bench testing, not a clinical study with a "test set" in the context of an AI/ML device evaluation.
- Data Provenance: The RCI Fixation screws were "tested in the laboratory," indicating internal bench testing. No country of origin for clinical data is relevant here. The data is prospective for this specific bench test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert consensus on images or pathology) is not relevant for this type of mechanical device bench testing.
4. Adjudication method for the test set
- Not applicable. This concept is for clinical studies with expert reviewers, not mechanical bench testing.
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 is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used
- The "ground truth" for the bench testing would be the measured mechanical properties (e.g., pull-out strength, insertion torque) compared against pre-defined engineering specifications for "suitable fixation strength."
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Study Description:
The safety and effectiveness of the RCI Fixation Screws were demonstrated through bench testing. The document states, "RCI Fixation screws have been tested in the laboratory and found to have suitable fixation strength for use as interference screws." This implies that the device underwent mechanical tests to assess its ability to provide stable fixation for bone-tunnel-bone or hamstring grafts, as required for ACL/PCL reconstruction. While specific quantitative results are not provided in this summary, the conclusion is that the device met the internal specifications for fixation strength. The 510(k) summary primarily relies on demonstrating substantial equivalence to existing legally marketed devices (Arthrex Extra Long Screw K915424 and RCI Screw K945687) by comparing indications, dimensions, material, and sterilization methods. The bench testing further supported the performance claim for the new device.
§ 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.