(114 days)
The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
Subject of this premarket notification is an extension to the EVOS family of plates and screws, the EVOS Small Fragment Plating System. This system features similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC Plating System) and also shares some instruments and implants from the existing EVOS MINI Plating System. It is comprised of a variety of locking and non-locking 2.7mm and 3.5mm straight plates as well as 3.5mm locking and non-locking screws and 4.7mm non-locking osteopenia screws.
The provided document is a 510(k) premarket notification for a medical device (EVOS Small Fragment Plating System), not a study analyzing AI performance. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.
However, I can extract the acceptance criteria and study descriptions for the mechanical performance of the physical EVOS Small Fragment Plating System, as detailed in the document.
Here's the information based on the provided text, focusing on the mechanical testing of the device itself:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Finite Element Analysis (FEA) | The subject bone plates exhibited similar or superior structural strength compared to the existing predicates. Results of the FEA demonstrated that the plates identified for mechanical testing were the appropriate bone plates because they possessed the highest stress concentrations. | The acceptance criteria were met. |
| Four-point Bend Fatigue Testing | The bending fatigue performance achieved by the proposed bone plates met the acceptance criteria in that they were found to be similar to the bending fatigue performance of a previously cleared predicate. | The acceptance criterion was met. |
| Torque to Failure Testing (Bone Screws) | The static torsional performance of the EVOS screws was found to be similar to the static torsional performance of a previously cleared predicate device. | The acceptance criterion was met. |
| Axial Pull-out Testing (Osteopenia Screws) | The subject screws that were tested showed similar or superior (higher) pull-out strength compared to the predicates. | The acceptance criterion was met. |
| Static Cantilever Bending Performance (Locking Mechanism) | The results met the acceptance criteria in that they were similar or superior (higher) than the predicates. (Evaluated through threaded locking mechanism and variable angle locking holes for 3.5mm and 2.7mm screws). | The acceptance criteria were met. |
| Packaging Testing | The product will not be damaged during shipment and will adequately maintain sterility post shipment. | The results of this testing showed 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 FDA Guidance documents ("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). | Completed and met the acceptable endotoxin limits. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each mechanical test. The document mentions "worst-case designs" for FEA and fatigue testing, and specific sizes of screws (3.5mm, 4.7mm) for others. Typically, mechanical testing involves a limited number of samples (e.g., 5-10 per test condition) to satisfy a statistical confidence level or regulatory requirement, but the exact numbers are not provided here.
- Data Provenance: Not applicable as these are pre-clinical (benchtop) tests of the device's physical properties, not clinical data from patients. The testing was conducted by Smith & Nephew, Inc.
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)
Not applicable. These are engineering and mechanical tests, not analyses requiring expert human interpretation or ground truth establishment in a clinical sense. The "ground truth" is defined by the objective measurement of mechanical properties against predetermined performance standards, often based on existing predicate devices or industry standards like ASTM.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The results are quantitative measurements against objective criteria.
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 document describes the mechanical testing of a medical implant, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes the mechanical testing of a medical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical testing is based on:
- Performance of legally marketed predicate devices. The acceptance criteria consistently refer to being "similar or superior" to predicates.
- Adherence to industry standards (e.g., ASTM F543 for screw testing).
- Compliance with FDA Guidance documents for sterility and endotoxin testing.
8. The sample size for the training set
Not applicable. This is not an AI study requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI study requiring a training set or its associated ground truth establishment.
§ 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.