(217 days)
Cable-Ready® Bone Plate System: The Cable-Ready® Bone Plate with Cerclage Cable is indicated for use where wire, cable, or band cerclage is used in combination with bone plates to provide fixation and/or stabilization of long bones femur, tibia and humerus. Examples include periprosthetic fractures or bone loss, comminuted shaft fractures, and nonunions of previous fractures with or without failed hardware.
The Cable-Ready® Bone Plate System is used to address complicated fractures and reconstruction of the long bones - femur, tibia and humerus. These devices are used as a compressive force to aid the surgeon in containing fracture fragments as they heal. The plate is placed on the bone and secured with a multifilament cable that is inserted into the plate and passed around the bone to the other side of the plate where it is attached and tightened, securing the fracture(s) in place. Cortical bone screws are used for additional fixation as needed.
The bone plates are offered in 3 lengths – 187mm (6 holes), 246mm (8 holes) and 305mm (10 holes). The cerclage cable is 1.8mm in diameter and 610mm in length. Both the bone plates and cable are manufactured from 316L stainless steel.
The provided document is a 510(k) summary for the Zimmer Cable-Ready® Cable Grip System: Cable-Ready® Bone Plate System. This is a medical device for bone fixation, and the summary details its substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or standalone algorithm evaluation in the way that would typically apply to software or AI devices.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this type of device submission and the information provided.
Based on the available information, here's what can be extracted:
1. Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" are presented differently for this type of medical device which relies on demonstrating substantial equivalence to a predicate device. The "performance" here primarily refers to the device's physical and mechanical properties being comparable or superior to the predicate, ensuring it performs its intended function safely and effectively.
| Acceptance Criteria (Implied by Substantial Equivalence and Performance Testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 and GLP standards. | All biocompatibility testing passed. |
| Mechanical Strength/Performance: Differences in length, number of screw holes, and crimp mechanism between subject and predicate devices should not affect clinical strength. | Engineering analysis establishes that these differences do not affect the clinical strength of the subject bone plates and cable. |
| Intended Use: Comparable to predicate. | Intended use is similar to predicate devices. |
| Materials: Comparable to predicate. | Materials (316L stainless steel) are similar to predicate devices. |
| Basic Shape: Comparable to predicate. | Basic shape is similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission relies on non-clinical performance data (biocompatibility and engineering analysis) and comparison to predicate devices, not on a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No test set requiring expert-established ground truth was used for this submission.
4. Adjudication Method
Not applicable. No test set involving human review or adjudication was used for this submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as this is a physical medical device, not a diagnostic or AI-powered imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is adherence to established international standards (ISO 10993-1) and Good Laboratory Practices (GLP). For mechanical performance, the "ground truth" is robust engineering analysis and scientific principles demonstrating that design variations do not compromise clinical strength.
8. The Sample Size for the Training Set
Not applicable. No training set was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set was used.
§ 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.