(89 days)
The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial Osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws that join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.
The Arthrex Modified Osteotomy System consists of plates and screws that join together to correct abnormalities or trauma related injuries. Different sizes and configurations of the Modified Osteotomy System are available to address patient needs. The plates are configured to provide as much support as possible. The plates and screws are manufactured from stainless steel and are sold non-sterile.
The provided document is a 510(k) summary for the "Modified Arthrex Opening Wedge Osteotomy System," submitted in 2002. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. The document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would be provided for a novel diagnostic algorithm or image analysis software.
Instead, the submission focuses on demonstrating substantial equivalence to existing devices. This typically involves comparing design, materials, manufacturing processes, and intended use. Performance testing for a device like a bone fixation system would usually involve mechanical bench testing (e.g., fatigue, static strength) to ensure the device performs as expected and is comparable to predicate devices in terms of its structural integrity and ability to provide fixation. However, these specific test results and acceptance criteria are not detailed in this 510(k) summary.
Therefore, many of the requested items (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance for algorithms) are not applicable or not present in this type of regulatory document for a bone fixation system.
Here's an analysis based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
- Not provided in this 510(k) summary. This document emphasizes substantial equivalence to existing predicate devices rather than specific quantitative performance metrics against acceptance criteria. For a bone fixation system, performance criteria would typically include mechanical properties (e.g., strength, fatigue life), biocompatibility, and sterilization effectiveness, but these details are not present.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No "test set" in the context of diagnostic performance or algorithmic evaluation is mentioned. The device is a physical bone fixation system.
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 / Not provided. This concept is generally relevant for diagnostic or AI-driven devices where human experts establish ground truth for algorithm training or evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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 / Not provided. This type of study is for diagnostic devices, particularly those involving human interpretation of images, often with AI assistance. The Modified Arthrex Opening Wedge Osteotomy System is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is relevant for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided.
8. The sample size for the training set
- Not applicable / Not provided.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
Summary of Device Information from the 510(k):
- Device Name: Modified Arthrex Opening Wedge Osteotomy System
- Intended Use: For Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial Osteotomies, and High Tibial Closing Osteotomies, used with bone screws for fixation following surgery. Treats non-union, malunion, and various fractures of proximal tibia, distal femur, and distal tibia. Intended to be used with adequate post-operative immobilization.
- Description: Consists of plates and screws made from stainless steel, sold non-sterile. Designed to provide support and correct abnormalities or trauma-related injuries.
- Substantial Equivalence: Claimed to be substantially equivalent to predicate devices with the same basic features and intended uses. Minor differences are stated not to raise questions concerning safety and effectiveness or affect performance, function, or intended use.
Conclusion:
The provided 510(k) summary (K0141555) for the Modified Arthrex Opening Wedge Osteotomy System focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for this type of medical device. It does not contain the detailed performance study data, acceptance criteria, or ground truth establishment methods typically associated with diagnostic or AI-driven medical devices. Information regarding specific mechanical testing parameters, sample sizes for such tests, or the acceptance criteria for those tests is not included in this high-level summary.
§ 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.