(32 days)
open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities
The titanium washers and titanium wires of the Ilizarov External Fixation System are single use devices designed for patients with the following indications: open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities. The titanium wires and washers have the same function as the existing stainless steel wires and washers. They are made of titanium for patients who have a sensitivity to stainless steel. The titanium components are primarily for patients that have allergy sensitivities. The washer and wires interconnect with the Ilizarov External Fixator System. The wires are inserted and attached to the rings of the circular fixator and rods of the Ilizarov External Fixator System. The wires are available with an olive shaped stopper to create interfragmentary compression or to add more stability to the assemblage. The washer may be used with the wires with stopper to provide surface area for the stopper to push up against.
This document is a Summary of Safety and Effectiveness for medical devices (implants). It describes the intended use and materials of the devices (titanium washers, wires for external fixation systems) and states that fatigue testing was performed on the wires, with acceptable results.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined in your request.
The request asks for details typically associated with the evaluation of AI/ML-powered diagnostic or predictive devices, focusing on performance metrics like sensitivity, specificity, AUC, and expert-based ground truth. The document provided is for a physical medical device (external fixator components) and focuses on mechanical properties like fatigue life, comparing new materials to existing ones.
Therefore, I cannot fulfill your request for the specific details listed, as they are not present in the provided text.
Here's why:
- No "device performance" in terms of diagnostic accuracy: The document discusses the mechanical performance (fatigue) of wires, not the diagnostic or predictive performance of an algorithm.
- No "acceptance criteria" related to diagnostic metrics: There are no explicit thresholds for sensitivity, specificity, etc. The acceptance criteria for the wire would likely be failure rates or cycles to failure under specific loads, which are not detailed here beyond "acceptable results."
- No "sample size" for test sets of clinical images/data: The testing mentioned is for the physical device's mechanical properties, not an algorithm's performance on a dataset.
- No "data provenance," "experts for ground truth," "adjudication methods," "MRMC studies," or "standalone performance": These concepts are entirely irrelevant to the mechanical testing of a medical implant and are not mentioned.
- No "ground truth" concept in the AI sense: For physical devices, "ground truth" might refer to known material properties or engineering specifications, but not expert-labeled data.
- No "training set" or "how ground truth for training set was established": These are AI/ML specific concepts.
In summary, the provided document is not relevant to the kind of performance evaluation questions you are asking.
§ 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.