(88 days)
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Periprosthetic fractures
- · Comminuted fractures
- · Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions
The NCB (Non-Contact Bridging) Periprosthetic Femur Polyaxial Locking Plate System is a line of polyaxial locking plates for the treatment of femur fractures, particularly of periprosthetic femur factures. It consists primarily of Proximal Femur Plates, Distal Femur Plates, and Curved Shaft Plates. The NCB technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. In the locked mode the NCB Periprosthetic plate acts as an internal fixator without contact between the plate and the bone surface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers, which are threaded into the plate holes prior to plate insertion. Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy.
The provided document is a 510(k) summary for a medical device called the "NCB® Periprosthetic Femur Polyaxial Locking Plate System." It details the device's description, intended use, and a comparison to predicate devices, but does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.
This document focuses on the mechanical and biocompatibility aspects of an implantable medical device, rather than a diagnostic or therapeutic AI algorithm. Therefore, many of the requested elements (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not present in this type of submission.
Here's an attempt to address the request based on the available information, noting where information is not relevant or unavailable:
Acceptance Criteria and Study for NCB® Periprosthetic Femur Polyaxial Locking Plate System
The acceptance criteria for this device are demonstrated through mechanical performance testing and equivalency to previously cleared predicate devices. The study conducted is non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Outcome Expectation | Reported Device Performance (as described) |
|---|---|---|
| Mechanical Strength/Performance | Device is safe and effective and substantially equivalent to predicate devices for intended use. | Plate testing/analysis performed included: |
- Construct fatigue - Proximal Femur Plate
- Distal Femur Plate strength
- Shaft Plate strength
- NCB screw/Shaft Plate compression slot interface evaluation
- Construct fatigue - Proximal Femur Plate with Cable and Cable Button
System screws were tested to determine: - Starting load
- Driving torque
- Torque to failure
The "results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." |
| Material Biocompatibility | Made of materials demonstrated to be safe for implantation. | Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy. This is implicitly accepted as safe based on widespread use of titanium alloys in predicate devices and medical implants. |
| Intended Use Equivalence | Comparable to predicate devices in intended use. | "The NCB Periprosthetic Femur Polyaxial Locking Plate System is similar in intended use... to the predicate devices." |
| Sterility | Comparable to predicate devices in sterility. | "The NCB Periprosthetic Femur Polyaxial Locking Plate System is similar in... sterility... to the predicate devices." |
| Literature Support (Osteopenic Bone) | Use in osteopenic bone is substantiated. | "A literature review was conducted to substantiate the use of the proposed device in osteopenic bone." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For mechanical testing, the "sample size" would refer to the number of devices or components tested. The data provenance would be a lab setting, likely in the US or Switzerland (where the sponsor has offices). These would be prospective lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The "ground truth" for this device comes from engineering standards, mechanical testing results, and established material science. There isn't a human expert "ground truth" establishment in the context of diagnostic interpretation for this type of device. The expertise lies with the engineers and material scientists conducting and interpreting the lab tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). Mechanical testing results are objective measurements.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a bone fixation implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical implantable device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering standards, mechanical material property data, fatigue testing, strength testing, and torque specifications. For the "use in osteopenic bone," a literature review served as the basis for substantiation. Substantial equivalence to predicate devices is also a key component of the "ground truth" for regulatory clearance.
8. The sample size for the training set
This information is not applicable/provided. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" for this device.
§ 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.