(27 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, acctabulum, metacarpals, metatarsals, and clavicle.
The subject of this special premarket notification are minor modifications to the 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws (fully and partially threaded) previously cleared for market via Traditional 510(k), K162078. Design modifications described in this submission include minor updates to the tip of the cortex screw design and an increase in the screw head diameter for both the cortex and osteopenia screws.
The subject EVOS Small Fragment non-locking screws are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.
The provided text is a 510(k) premarket notification for a medical device, the EVOS Small Fragment Plating System, specifically concerning minor modifications to existing non-locking screws. This document outlines the regulatory submission process and the justification for substantial equivalence to a predicate device.
It's important to understand that a 510(k) notification for a Class II medical device like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a clinical study to prove the device meets specific acceptance criteria in a patient population. The "acceptance criteria" here refer to mechanical performance tests to show that the minor design changes do not negatively impact the device's safety and effectiveness compared to the predicate.
Therefore, the requested information elements related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. This document describes a pre-clinical mechanical testing study.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Device: EVOS Small Fragment Plating System (modified 3.5mm non-locking cortex screws and 4.7mm non-locking osteopenia screws)
| Acceptance Criteria Category | Specific Test/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Screw Insertion (Cortex Screws) | Performance similar or superior to existing EVOS screw design. | "Results of the testing demonstrated that screws manufactured with the modified tip performed similar or superior to the existing EVOS screw design." |
| Mechanical Performance | Maximum Stripping Torque (Modified Head Screws) | Significantly different (specifically, an increase) in maximum stripping torque compared to the current EVOS screw design to ensure adequate strength. | "Results of the testing demonstrated that the proposed head design modification met the acceptance criteria in that they were significantly different compared to the current EVOS screw design (increase in maximum stripping torque)." (This implies a higher stripping torque is desirable for improved performance/security). |
| Biocompatibility/Safety | Pyrogenicity | Not a new worst-case device for pyrogenicity compared to existing cleared products. | "Pyrogen testing was previously conducted for EVOS screws to support clearance of K162078. Existing results... as well as other implants cleaned using the same cleaning system that are considered more worst-case in terms of features, were reviewed and it was determined that the subject devices do not represent a new worst-case device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of screws or test replicates used for the screw insertion and maximum stripping torque tests. This level of detail is typically found in the full test reports, which are not included in this summary.
- Data Provenance: The studies were pre-clinical mechanical tests performed by the manufacturer (Smith & Nephew, Inc.). The data would be internally generated from laboratory testing. It is not patient or human subject data, so concepts like "country of origin" or "retrospective/prospective" in a clinical sense do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This was a pre-clinical mechanical testing study, not a study involving human interpretation of data where "ground truth" would be established by medical experts (e.g., radiologists). The "ground truth" is derived from direct physical measurements and engineering standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this was a pre-clinical mechanical testing study, there was no need for adjudication by multiple experts. The results are quantitative measurements from lab equipment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is a type of clinical study evaluating diagnostic accuracy (e.g., of an imaging algorithm) with multiple readers and cases. This submission is for a bone fixation system and involves pre-clinical mechanical testing, not a diagnostic or clinical comparative effectiveness study of human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not Applicable. This device is a physical medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the mechanical tests (screw insertion, stripping torque), the "ground truth" is based on engineering measurements and material science principles. The performance is compared against established benchmarks or the performance of the predicate device to ensure equivalence or improvement.
- For pyrogenicity, the "ground truth" is based on established testing methodologies and safety standards for medical device biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this pre-clinical mechanical testing for a physical implant. The concept of a training set applies to AI/ML algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See #8)
§ 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.