(86 days)
The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.
The Cable-Ready Cable Grip System Cable Button is a temporary internal fixation component used in conjunction with Zimmer Locking Bone Plates and Cerclage Cables. The Cable Button is threaded into a vacant screw hole of Zimmer Locking Bone Plates and provides a positioning point for a Cerclage Cable. The Cable Button is available in Titanium (Ti-6AL-4V Alloy) and Stainless Steel (22-13-5 SST).
This document describes the Zimmer Cable Ready® Cable Grip System Cable Button, a medical device for orthopedic use. Based on the provided text, the device's performance assessment is limited to non-clinical testing.
Here's the information extracted and organized:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Requirements | "Testing and Engineering Analysis demonstrates that the proposed devices meet performance requirements." (Specific criteria are not detailed in this document.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The document states "Non-Clinical Performance and Conclusions: Testing and Engineering Analysis demonstrates that the proposed devices meet performance requirements." This implies bench testing or simulations, not a clinical test set with human or animal samples.
- Data Provenance: Not applicable for a clinical test set. The testing was non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. As described, the evaluation was non-clinical and did not involve establishing ground truth from expert clinical assessment.
4. Adjudication Method for the Test Set
- Not applicable. No expert-based adjudication was mentioned for non-clinical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document explicitly states: "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices." Therefore, an MRMC study was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical orthopedic implant, not an AI or algorithmic system.
7. The Type of Ground Truth Used
- Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical performance, the "ground truth" would be established engineering specifications and benchmarks that the device had to meet through testing and analysis.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/machine learning model.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.