(105 days)
The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.
Homedica Osteonics is extending the Variax Distal Radius Plates of the Variax Distal Radius Plating System to include XXL sized plates as well as to modify the indications for use for the XXL Volar Distal Radius Plates to include Osteotomies, non-unions and mal-unions.
Each plate will accept a locking screw, bone screws, locking pegs, and partially threaded screws. The XXL plates are precontoured performed for palmer, fixation. Screws are selftapping and have either cross-pin or torx heads.
Plates are offerered in 5,8,11,and 15 hole options with a 2mm distal profile height and 3mm profile shaft height. All plates are straight and pre-contoured to fit the radial bow beyond the shaft. Gliding holes all for allignment of the plate and allow for additional bone reduction if required.
This K100271 document is a 510(k) Summary of Safety and Effectiveness for the VariAx Distal Radius Line Extension of XXL Plates. It describes a medical device (bone plates and screws) and seeks to demonstrate its substantial equivalence to existing devices.
The document does not contain information about software, AI, or diagnostic performance studies. Instead, it focuses on the mechanical and design equivalence of bone plates and screws. Therefore, it does not provide the specific details requested for acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies that would be relevant for a diagnostic or AI-based device.
Based on the provided text, here's what can be extracted and a clear statement of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe acceptance criteria or reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) or human reader improvement for an AI system. Instead, the "performance" discussed is related to the mechanical properties and design of the bone plates to establish substantial equivalence.
| Item Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Design Equivalence | Substantially equivalent to predicate devices in intended use, design, materials, and operational principles, and for its intended use. | Based upon mechanical testing, "the VariAx Distal Radius Line Extension of XXL Plates is substantially equivalent for its intended use to other plating systems currently on the market." |
2. Sample size used for the test set and the data provenance
Not applicable. This document refers to mechanical testing for bone plates, not a test set for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document refers to mechanical testing for bone plates, not ground truth for a diagnostic algorithm.
4. Adjudication method for the test set
Not applicable. This document refers to mechanical testing for bone plates, not a test set for a diagnostic algorithm.
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
No. This document describes bone plates and screws, not an AI-assisted diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This document describes bone plates and screws, not an AI algorithm.
7. The type of ground truth used
Not applicable. This document refers to mechanical testing for bone plates, not ground truth for a diagnostic algorithm. The "ground truth" for mechanical testing would implicitly be the established mechanical engineering standards and performance of the predicate devices.
8. The sample size for the training set
Not applicable. This document describes bone plates and screws, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This document describes bone plates and screws, not an AI algorithm.
In summary, the provided document K100271 pertains to the regulatory submission for a physical medical device (bone plates and screws) and primarily establishes substantial equivalence based on mechanical testing and design attributes. It does not involve any AI, software, or diagnostic performance claims that would necessitate the types of studies and criteria outlined in the input request.
§ 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.