(78 days)
Ilizarov Drill Tip Wires are intended to be used for the following indications:
Post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; and infected fractures or nonunions.
Ilizarov Drill Tip Wires are for single use only.
The subject Ilizarov Drill Tip Wires are comprised of implantable anchorage elements designed for use in a multilateral (i.e. a circular) fixator assembly comprised of a structurally purposeful arrangement of simple or complex bridge elements, connection elements and anchorage elements. The subject devices are manufactured from implant grade stainless steel material. Compared to the predicate devices, the subject devices will be available in the following configurations:
Ilizarov Drill Tip Wire, 1.8mm x 400mm
Ilizarov Drill Tip Wire with Stopper, 1.8mm x 400mm
Acceptance Criteria and Study for Ilizarov Drill Tip Wires (K130479)
This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Ilizarov Drill Tip Wires (K130479) to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify explicit numerical acceptance criteria for the "cutting performance of the wire." Instead, it states that "Mechanical test results were compared against predicate devices." The implicit acceptance criterion is that the subject device's performance in these mechanical tests should be comparable to or not worse than those of the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Cutting performance (number of start/stops prior until failure) comparable to predicate devices | Mechanical test results were compared against predicate devices. (Specific quantitative results are not provided in the summary) |
| Cutting performance (time to insertion) comparable to predicate devices | Mechanical test results were compared against predicate devices. (Specific quantitative results are not provided in the summary) |
| Cutting performance (insertion temperature) comparable to predicate devices | Mechanical test results were compared against predicate devices. (Specific quantitative results are not provided in the summary) |
Note: The provided 510(k) summary is high-level and does not include the detailed quantitative results of the specific mechanical tests. A full engineering report or test protocol would typically contain these specific values and their comparison to established thresholds or predicate device performance.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the sample size (number of wires tested) for the preclinical bench testing.
- Data Provenance: The preclinical testing was conducted by Smith & Nephew, Inc., implying it was internal testing. The country of origin of the data is not specified but is implicitly the manufacturing/testing location of Smith & Nephew, Inc. (Memphis, TN, USA is listed as their address). The nature of the testing (pre-clinical bench testing) indicates it was prospective for the purpose of this submission.
3. Number and Qualifications of Experts for Ground Truth Establishment
This submission primarily relies on bench testing for substantial equivalence. Therefore:
- Number of Experts: Not applicable in the context of human expert review for establishing ground truth on a test set, as the ground truth is based on physical mechanical properties measured in a lab setting.
- Qualifications of Experts: Not applicable, as expert consensus on a test set (e.g., medical image interpretation) was not performed. The testing would have been conducted by engineers or technicians qualified in materials testing and mechanical analysis.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to physical devices undergoing mechanical tests, not a set of clinical cases requiring expert interpretation and adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a surgical wire, and its performance is evaluated through mechanical bench testing, not clinical imaging or diagnostic interpretation where MRMC studies are typically employed.
6. Standalone (Algorithm Only) Performance Study
No. A standalone performance study of an algorithm was not conducted. This device is a physical medical implant, not a software-based algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for the device's evaluation was physical mechanical properties measured through preclinical bench testing. This includes objective measurements of "cutting performance including: number of start/stops prior until failure, time to insertion and insertion temperature." The performance was then compared against the observed mechanical properties of legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The data generated was for verification and validation of the physical product's performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device like this.
§ 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.