(57 days)
The implants of the Alians Clavicle range are dedicated to the fixation of fractures, mal-unions and osteotomies of the clavicle in adults.
The Alians Clavicle range consists of plates and screws designed for fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle in adults.
The implants of the Alians Clavicle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Alians Clavicle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial C) contain implants and instruments provided sterile by gamma sterilization. The Initial C kits contain implants (1 plate + screws), and instrumentation.
The provided document is a 510(k) summary for the "Alians Clavicle range" device. This type of regulatory submission is for medical devices that are substantially equivalent to legally marketed predicate devices, not for novel AI/software devices requiring the kind of extensive performance criteria and studies outlined in your request.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission. This document describes a traditional orthopaedic medical device (bone fixation plates and screws), not an AI/ML algorithm.
However, I can extract the acceptance criteria and study information that is relevant to this type of device and present it in your requested format.
Acceptance Criteria and Device Performance for Alians Clavicle Range
| Acceptance Criteria Category | Description & Performance |
|---|---|
| Material Equivalence | The device uses Titanium alloy Ti-6Al-4V, which conforms to ASTM F 136 and/or ISO 5832-3. This is considered substantially equivalent to the materials of the predicate devices. |
| Mechanical Performance | Acceptance Criteria: The device must demonstrate mechanical safety and performance equivalent to or better than the predicate device. |
| Reported Performance: Engineering analyses (non-clinical testing) were conducted in comparison with the Clavicle Locking Plating System of Newclip Technics (K100944). The analyses showed that the Alians Clavicle range is as strong or stronger than the predicate. | |
| Biological Safety (LAL) | Acceptance Criteria: The device must meet the endotoxin limit. |
| Reported Performance: LAL testing was performed to demonstrate that the subject device meets **the endotoxin limit of |
§ 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.