(58 days)
NCB® Polyaxial Locking Plate System:
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies.
NCB® Periprosthetic Femur Plate System:
The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic fractures.
If combined with the NCB Periprosthetic Trochanter Plate and Connection Screw, the NCB Periprosthetic Proximal Femur Plate is additionally indicated for temporary internal fixation and stabilization of greater trochanter fractures and osteotomies including re-attachment of the greater trochanter following fracture and osteotomy in total hip arthroplasty.
The NCB Periprosthetic Trochanter Plate and Connection Screw can only be used in combination with the NCB Periprosthetic Proximal Femur Plate.
NCB® Cable Button:
The NCB Cable Button for the NCB Polyaxial Locking Plate System in combination with the Zimmer Biomet NCB Polyaxial Locking Plate System and Cable-Ready System Cerclage Cables is indicated for temporary internal fixation of fractures and osteotomies.
NCB® Straight Narrow Shaft Plate
The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including periprosthetic fractures.
NCB® Polyaxial Locking Plate System
The NCB (Non-Contact-Bridging) Polyaxial Locking Plate System is a plate solution intended for the treatures and osteotomies of the distal femur (NCB DF), proximal humerus (NCB PH) and proximal tibia (NCB PT). NCB plate holes allow for polyaxial screw placement (30° cone) with subsequent screw locking, the screws can act as lag screws and be used for fracture reduction. In the locked mode, the plates act as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment.
An additional extension tuberculum minus plate can be assembled to the humeral plate with cerclage wire technique for fixation of anteroposterior (AP) tuberculum minus fractures. NCB femoral, humeral and tibial plates, cortical, cancellous and cannulated screws, locking cap, blind screw inserts and spacers are made from titanium alloy Protasul®-64 (Ti-6Al-4V - ISO 5832-3/ASTM F136). The tuberculum minus plate is made from cpTi (ISO 5832-2/ASTM F67), cortical screws from titanium alloy Protasul-100 (Ti-6Al-7Nb ISO 5832-11/ASTM F1295) and the cerclage wire from 1.4441 stainless steel Protasul-S (ISO 5832-1/ASTM F138-F139).
NCB® Periprosthetic Femur Plate System
The NCB (Non-Contact-Bridging) Periprosthetic Femur Plate System is a line of polyaxial locking plates for the treatment of femoral fractures, particularly of periprosthetic femoral fractures. The system consists of Proximal Femur Plates, Curved Shaft Plates, Trochanter Plates and a Connection Screw. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Periprosthetic Plate acts as an internal fixator without contact between the bone suface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.
Additionally, within this system, the NCB Periprosthetic Trochanter Plates used in combination with the NCB Periprosthetic Proximal Femur Plates for the treatment of proximal femoral fractures, which includes greater trochanter fractures and osteotomies. The Connection Screw for NCB Periprosthetic Trochanter Plate is used to attach the Proximal Femur Plate. The NCB Periprosthetic Trochanter Plates contain threaded conical holes which allow for monoaxial screw placement using locking screws with threaded heads. Non-locking cortical screws can also be used.
The NCB Periprosthetic Proximal Femur Plates are available in five lengths (Length=245mm, 324mm, 363mm, 401mm) which can be used either as standalone implants or in combination with the NCB Periprosthetic Trochanter Plates. The NCB Periprosthetic Proximal Femur Plate short (Length=115 mm) is used only in combination with the NCB Periprosthetic Trochanter Plates. The NCB Curved Shaft Plates are also included in the NCB Periprosthetic Femur Plate System and are specifically designed for the femur. The Proximal Femur Plates, Distal Femur Plates, Trochanter Plates and Connection Screw are made of a titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3).
NCB Cable Button for NCB Polyaxial Locking Plate
The NCB (Non-Contact-Bridging) Cable Button for NCB Polyaxial Locking Plate is a temporary internal fixation component used in conjunction with Zimmer Biomet NCB Polyaxial Locking Plate System Cerclage Cables. The Cable Button is threaded into a vacant screw hole of the Zimmer Biomet NCB Polyaxial Locking Plate System and provides a positioning point for a Cerclage Cable.
The Cable Button is made of titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3) and has a color anodization (Type III).
NCB Straight Narrow Shaft Plate
The NCB (Non-Contact-Bridging) Straight Narrow Shaft Plate is a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.
The NCB Straight Narrow Shaft Plate is made of Titanium alloy [Ti6Al4V (Protasul®-64WF) ISO 5832-3].
Here's an analysis of the provided text regarding the acceptance criteria and study for the NCB® Polyaxial Locking Plate System and related devices.
Based on the provided FDA 510(k) summary, this submission is for a medical device (bone fixation plates), not an AI/software device. Therefore, many of the requested categories related to AI/software performance metrics, ground truth, expert adjudication, and MRMC studies are not applicable.
This document describes a substantial equivalence submission for metal bone fixation implants. The "acceptance criteria" and "device performance" in this context refer to mechanical, material, and biocompatibility testing results, not AI model performance metrics like sensitivity, specificity, or F1-score.
The document states that "Clinical data and conclusions were not needed for this device," and the substantial equivalence determination relies on comparisons to legally marketed predicate devices, along with non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a mechanical medical device, the "acceptance criteria" are typically defined by recognized standards for mechanical properties, biocompatibility, and sterilization. The "reported device performance" would be the results of testing against those standards.
| Acceptance Criteria Category | Specific Test/Standard (Example) | Reported Device Performance (Summary from document) |
|---|---|---|
| Material Properties | ISO 5832-3, ASTM F136 (Ti-6Al-4V) | Materials are "identical" to predicate devices, made from specified titanium alloys and stainless steel. Properties are presumed to meet standards. |
| Mechanical Performance | (Implied by equivalence to predicate) | "same operating principle, incorporate the same basic design... performance data and analyses demonstrate that any differences do not raise different questions of safety and effectiveness." (Mechanical testing likely performed but not detailed in this summary). |
| Biocompatibility | (Implied by equivalence to predicate) | "manufactured and sterilized using the same materials and processes as the predicate devices." (Biocompatibility of materials is established for predicates). |
| MR Compatibility | ASTM F2503-20, ASTM F2119-07R13, ASTM F2213-17, ASTM F2052-21, ASTM F2182-19E02 | Evaluation performed to support MR Conditional labeling. Specific results (e.g., maximum temperature rise, artifact size) are not detailed in this summary but are implied to be within acceptable limits as the device is cleared. |
| Sterilization | (Implied by equivalence to predicate) | "manufactured and sterilized using the same materials and processes as the predicate devices." (Sterilization validation presumed). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a medical device (bone plate) and not an AI/software device with a "test set" in the computational sense. The "testing" refers to non-clinical mechanical and material tests. No patient data or clinical studies are mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of AI models does not apply to this type of device.
4. Adjudication Method for the Test Set
Not applicable.
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 device is not an AI product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive mechanical implant, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. For a mechanical device, performance is evaluated against engineering specifications and industry standards, not "ground truth" derived from expert consensus, pathology, or outcomes data in the way an AI system is evaluated.
8. The Sample Size for the Training Set
Not applicable. This device does not use a training set as it is not an AI/machine learning product.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.