(129 days)
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.
Subject of this premarket notification is the EVOS Large Fragment Plating System. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts, the proposed plates feature a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and non-locking screws described in this premarket notification. It is comprised of a variety of locking and non-locking 4.5mm straight plates, 3.5mm and 4.5mm anatomical plates as well as previously cleared 3.5mm locking and non-locking screws and new 4.5mm locking and non-locking screws, 5.7mm cannulated locking screws, 6.5mm locking and nonlocking screws, and 6.7mm high-torque (osteopenia) screws.
The provided text describes the EVOS Large Fragment Plating System, a medical device for bone fracture fixation. The document details the pre-clinical testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Bending Performance (Static/Cantilever Bend Testing or Construct Fatigue Testing) | The subject plates should perform similar or superior to the predicate plates tested, when evaluated under the same conditions. (Identified through FEA as "worst case" plates) | Results determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions. |
| Locking Mechanism Performance (4.5mm Screws - Static Cantilever Bending and Fatigue) | The results should meet the acceptance criteria in that they were similar or superior (higher) than the predicates. (Evaluated through the threaded locking mechanism and variable angle locking holes) | The results met the acceptance criteria in that they were similar or superior (higher) than the predicates. |
| Torque to Failure Testing (4.5mm Bone Screws) | The static torsional performance of the EVOS screws should be similar to the static torsional performance of a previously cleared predicate device. (Following ASTM F543 guidelines) | The acceptance criterion was met in that the static torsional performance of the EVOS screws was found to be similar to the static torsional performance of a previously cleared predicate device. |
| Axial Pull-out Testing (4.5mm, 5.7mm, 6.5mm, 6.7mm Screws) | The subject screws should show similar or superior (higher) pull-out strength compared to the predicates OR meet the performance criteria from FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway. (Following ASTM F543 guidelines) | The acceptance criterion was met in that the subject screws that were tested showed similar or superior (higher) pull-out strength compared to the predicates or met the performance criteria from FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway. |
| Magnetic Resonance Imaging (MRI) Compatibility Testing | Compliant with FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014. | Testing was conducted as per the FDA's guidance. (Results are implied to have met the criteria as there is no mention of failure) |
| Packaging Verification Testing | The product will not be damaged during shipment and will adequately maintain sterility post shipment. | The results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment. |
| Bacterial Endotoxin Testing | Met acceptable endotoxin limits as stated in specific FDA Guidance documents and ANSI/AAMI ST72. | Testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72. |
| Biocompatibility Testing | (Implicitly, the device should be biocompatible as per relevant standards and guidance.) | EVOS Large Fragment Fracture Plating System Biocompatibility Testing conducted. (Results are implied to have met the criteria) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- The document does not explicitly state specific sample sizes for each mechanical test. Instead, it refers to evaluating "worst case plate designs" identified through Finite Element Analysis (FEA). While FEA itself is a computational method, the subsequent mechanical testing would involve a physical sample size. This information is a major gap in the provided text.
- The data provenance is pre-clinical testing, meaning it was conducted in a laboratory setting, not on human subjects. There is no information regarding country of origin of the data provided in the FDA letter.
- The testing is retrospective in the sense that it compares the new device to existing predicate devices already on the market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable as the studies described are pre-clinical mechanical and material tests, not clinical studies involving human patients or expert interpretation of medical images. "Ground truth" in this context refers to established engineering standards (e.g., ASTM F543) and performance characteristics of predicate devices against which the new device's performance is measured.
4. Adjudication Method for the Test Set:
- This information is not applicable for pre-clinical mechanical and material testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials involving human subjects where multiple experts evaluate outcomes or images.
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 imaging devices or AI-assisted clinical decision support tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The EVOS Plating System is a surgical implant, not a diagnostic or AI-driven tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this is not applicable. The device is an orthopedic implant, not a software algorithm.
7. The Type of Ground Truth Used:
- For the mechanical and material tests, the "ground truth" used for comparison falls into these categories:
- Predicate Device Performance: The primary ground truth is the established performance characteristics of the legally marketed predicate devices (e.g., Smith & Nephew Locking Bone Plate System (PERI-LOC)).
- Standardized Performance Criteria: For screws, specific FDA Guidance documents (e.g., "FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway") and international standards (e.g., ASTM F543, ANSI/AAMI ST72) serve as ground truth for acceptance.
8. The Sample Size for the Training Set:
- This information is not applicable. There is no "training set" in the context of mechanical pre-clinical testing for a surgical implant. Training sets are used in machine learning and AI development. The Finite Element Analysis (FEA) performed could be considered a form of "computational modeling" that informs the physical testing, but it's not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no "training set." The performance targets for the device were established based on the characteristics of predicate devices and relevant industry/regulatory standards.
§ 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.