(118 days)
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
The Tivanium 3.5mm Locking Screws are intended to be used with the NCB Polyaxial Locking Plate System.
The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method.
The Tivanium 3.5mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.
This document describes the Zimmer NCB® Polyaxial Locking Plate System and Zimmer® Universal Locking System with 3.5mm Tivanium® Ti-6Al-4V Alloy Locking Screws. It's a 510(k) premarket notification for a Class II medical device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (bone fixation plates and screws), the "acceptance criteria" are primarily related to safety, effectiveness, and substantial equivalence to predicate devices, rather than specific performance metrics like accuracy, sensitivity, or specificity commonly seen in diagnostic AI/software devices. The performance is assessed through non-clinical (laboratory/performance) testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device | NCB Polyaxial Locking Plate System: Indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. |
| Tivanium 3.5mm Locking Screws: Intended to be used with the NCB Polyaxial Locking Plate System. (Matches predicate's intended use) | ||
| Performance Characteristics | Similar to predicate device | Non-clinical (Laboratory / performance) testing demonstrated that the device is safe and effective. (Implies performance is comparable to predicate, meeting safety and effectiveness standards) |
| Design | Similar to predicate device | NCB plates are similar in design to the predicate device. |
| Universal Locking System screws have similar design characteristics. | ||
| Materials | Similar to predicate device (or justified difference) | NCB plates are similar in materials to the predicate device. |
| The proposed Universal Locking System screws are made from Tivanium (Ti-6Al-4V) alloy versus the Stainless Steel of the predicate device. (This difference was likely justified through non-clinical testing showing equivalence or superiority in relevant properties). | ||
| Safety and Effectiveness | Device is safe and effective | Non-clinical (Laboratory / performance) testing demonstrated that the device is safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
This device is a hardware implant (plates and screws for bone fixation). The performance testing described is non-clinical (laboratory/performance) testing, not clinical trials involving human subjects or data sets in the way AI/software devices are typically evaluated.
- Sample size for the test set: Not applicable in the context of clinical data. The document does not specify sample sizes for mechanical or laboratory tests, which would typically involve testing a certain number of devices or components under simulated conditions.
- Data provenance: Not applicable. The "data" comes from laboratory and performance testing, not human-derived data like images or patient records.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth for clinical data is not relevant here as the evaluation relies on non-clinical, laboratory performance testing of the hardware. The "ground truth" for such devices is established through engineering standards, biomechanical principles, and documented performance of predicate devices.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used for clinical data interpretation (e.g., in diagnostic studies) where human experts might disagree. This device was evaluated through non-clinical laboratory testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact of AI on human reader performance. This document pertains to a bone fixation hardware device, for which MRMC studies are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on engineering specifications, biomechanical testing standards, and performance characteristics established for bone fixation devices. It relies on laboratory test results demonstrating mechanical strength, fatigue resistance, biocompatibility (often implicitly covered by material commonality), and other physical properties under simulated conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware product, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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.