Search Results

Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and fragments and as non-load bearing stabilization and fixation of bone fragments.

The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.

The subject EVOS Mini-Fragment Plating System is a modification to a subset of the devices previously cleared Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886). It is an internal fixation plating system comprised of assorted implantable, small utility "flat" locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and fragments. Plates consist of groups of devices with a flat cross-section where the number of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile or non-sterile packaged condition.

The provided text describes a 510(k) premarket notification for a medical device, the "EVOS Mini-Fragment Plating System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials or extensive performance studies typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, the study design and acceptance criteria outlined in the original request—which are highly specific to AI/SaMD performance evaluation (e.g., AUC, sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment by experts, adjudication methods, training/test set sizes)—are not applicable to this traditional hardware medical device submission.

This submission focuses on mechanical bench testing to demonstrate that the new device (EVOS Mini-Fragment Plating System) performs comparably to its predicate devices in terms of physical properties and strength.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document, reimagined to fit the context of this specific product:

Acceptance Criteria and Device Performance for the EVOS Mini-Fragment Plating System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are based on "non-inferiority" to the predicate devices and relevant industry standards (ASTM F543).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of physical samples (plates, screws) tested for each category (e.g., "worst-case bone plates," "2.0mm, 2.4mm, and 2.7mm bone screws"). However, it implies testing was conducted on sufficient samples to draw conclusions about non-inferiority.
• Data Provenance: The testing was "non-clinical bench (mechanical) testing" conducted by or for Smith & Nephew. The provenance is internal corporate testing to support a regulatory submission, not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is a hardware device performance study focusing on mechanical properties, not an AI/SaMD study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective physical measurements and established engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing, there is no human interpretation or adjudication process in the sense of consensus on diagnostic findings. The results are quantitative measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. It is not applicable to the mechanical testing of bone plates and screws.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, in the context of device performance. The "standalone" performance here refers to the intrinsic mechanical performance of the plates and screws themselves, without human surgical interaction being part of the evaluation criteria for regulatory clearance. The tests demonstrate the device's physical properties independent of user variability in a real-world surgical setting.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements and Engineering Standards:
  • "Ground truth" for plate and screw fatigue: The number of log cycles to failure under specific bending moments, assessed against the performance of predicate devices.
  • "Ground truth" for screw torsional strength: The average torsional strength values, assessed against predicate devices and the minimum values specified in ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
  • Finite Element Analysis (FEA): Used to predict the "worst-case" plate, which then guides the selection of samples for physical testing. This acts as a computational "ground truth" to identify critical designs for physical validation.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning model where a "training set" of data is used to build an algorithm. The "training" in this context would be the design and engineering process, with the "test set" being the physical devices manufactured and tested.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8. The "ground truth" for the design of the device would be principles of biomechanical engineering, material science, and prior knowledge from predicate devices. The "validation" of this design comes from the bench testing.

In summary: The EVOS Mini-Fragment Plating System is a traditional medical device demonstrating substantial equivalence through non-clinical bench (mechanical) testing. Its "acceptance criteria" are based on showing non-inferiority in mechanical performance (fatigue life, torsional strength) compared to already cleared predicate devices and relevant ASTM standards. The study design and terminology requested in the prompt are tailored for AI/SaMD, which is a fundamentally different type of regulatory submission and performance evaluation.

Ask a specific question about this device