(44 days)
The proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.
The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout.
The provided text describes a medical device, the "Hand Innovations Diaphyseal Plate," and its regulatory clearance process, including information on its intended use, design, and comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/algorithm performance.
The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against predefined acceptance criteria for an AI or algorithm.
Therefore, I cannot provide a response to your request, as the necessary information regarding acceptance criteria and a study demonstrating algorithmic performance is absent from the provided text.
Here's why each numbered point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria in the context of an AI or algorithmic output, nor does it report such performance.
- Sample sized used for the test set and the data provenance: No test set for an AI/algorithm is described. The "testing" mentioned refers to pre-clinical testing for substantial equivalence, not algorithmic validation data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/algorithm test set.
- Adjudication method: Not applicable as there is no AI/algorithm test set requiring ground truth adjudication.
- 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: This is a traditional mechanical implant, not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm described.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as there is no AI or algorithm discussed.
- How the ground truth for the training set was established: Not applicable.
The "Performance Testing" mentioned in the "Summary of Substantial Equivalence" section refers to pre-clinical (e.g., mechanical) testing to ensure the device's physical properties are comparable to the predicate device, not the performance of an AI or algorithm.
§ 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.