(170 days)
Cable-Ready® GTR System - The Cable-Ready® GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally; the device is used to reattach the greater trochanter following fracture of the greater trochanter, nonunion of fracture, or previous osteotomy.
Cable-Ready® 1.8mm Cerclage Cables - The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle, as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanteric osteotomy during total hip arthroplasty.
The Cable-Ready Greater Trochanter Reattachment Short and Long (GTR) devices are used in combination with 1.8mm cobalt chrome alloy cerclage cables to stabilize fractures of the greater trochanter or reattach the greater trochanter after osteotomy in total hip replacement. The GTR devices are designed with two upper prongs that loop around the greater trochanter and two small fins on the lower side to prevent migration or rotation.
In addition to being used with the GTR devices, the cobalt chrome alloy 1.8mm cerclage cables, along with the stainless steel cables, can be used alone to secure bone fractures.
The provided FDA 510(k) summary for the Zimmer Cable-Ready® Cable Grip System (K151907) describes a medical device for bone fixation. However, it does not contain the detailed information necessary to complete the acceptance criteria table and the study description as requested.
This document focuses on establishing substantial equivalence for a physical medical device (bone cables and grip system) based on non-clinical performance (shelf life, biocompatibility, and fatigue testing), rather than an AI/software medical device requiring specific performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the following information from the provided text:
- Acceptance Criteria and Reported Device Performance (Table): The document states "A construct fatigue test...and an engineering analysis...demonstrate the subject devices are safe and effective," but it does not provide specific quantitative acceptance criteria or performance metrics (e.g., in terms of force, displacement, or number of cycles) that would typically be found for an AI device.
- Sample size used for the test set and the data provenance: Not applicable as it's not an AI/data-driven study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical data and conclusions were not needed for these devices to show substantial equivalence," indicating no human reader study was performed.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical device, not an algorithm.
- Type of ground truth used: Not applicable for an AI sense. The "ground truth" for this device would be its mechanical integrity and biocompatibility, demonstrated through non-clinical laboratory tests.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information regarding device performance:
The document mentions three non-clinical performance assessments:
- Shelf Life Accelerated aging testing: Concluded that sterile devices have a shelf life of 10 years.
- Biocompatibility testing: Conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Evaluation:
- A construct fatigue test for the GTR system.
- An engineering analysis for the 1.8mm cerclage cables.
These tests were used to demonstrate that the subject devices are safe and effective and substantially equivalent to predicate devices. However, no specific performance values or acceptance criteria for these tests are detailed in this summary.
Conclusion:
The provided document describes a traditional 510(k) submission for a physical orthopedic device and relies on non-clinical engineering and bench testing to demonstrate substantial equivalence. It does not involve AI or software, and therefore, the requested information pertaining to AI/ML device evaluation criteria (such as sensitivity, specificity, reader studies, ground truth establishment from expert consensus, etc.) is not present.
§ 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.