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510(k) Data Aggregation
(239 days)
Alians Elbow Locking Plating System
The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults
The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
The implants of the Alians Elbow Locking Plating System 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 Elbow Locking Plating System range will be provided non sterile for sterilization by health care professionals prior to use or sterile.
Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3). The implants of the Alians Elbow Locking Function: Plating System are intended for the fixation of fractures and osteotomies of the distal humerus and the proximal ulna in adults.
This document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System." As such, it does not contain any information regarding acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
- Design: Plates and screws.
- Materials: Titanium alloy Ti-6Al-4V.
- Mechanical Safety and Performance: Evaluated through engineering analysis (bending strength, bending stiffness, removable support).
- Lack of Clinical Studies: Explicitly states "No clinical studies were performed."
Therefore, I cannot provide the requested information about acceptance criteria or an AI-driven device study from this document. The provided text is for a traditional medical implant device, not an AI or software-as-a-medical-device product.
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(370 days)
Alians Elbow Locking Plating System
The Alians Elbow Locking Plating System is intended for the fixation of fractures and ostectornies of the distal humerus and proximal ulna in adults.
The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
The plates and screws are manufactured from titanium alloy and are color anodized.
The Alians Elbow Locking Plating system will be provided non-sterile for sterilization by health care professionals prior to use. A sterile version of the Alians Elbow Locking Plating System is provided in single use sterile kits, called Initial O kits, including one plate, screws and single use instrumentation necessary for the implantation.
I am sorry, but based on the provided text, there is no information about an AI/ML-driven device or study parameters that would allow me to populate the requested table and describe the study proving the device meets acceptance criteria.
The document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System," which is a metallic bone fixation appliance. It discusses the regulatory review process, device description, indications for use, and a comparison to predicate devices, including mechanical testing (non-clinical tests).
There is no mention of:
- Acceptance criteria for an AI/ML device
- Device performance reported for an AI/ML device
- Test set sample sizes, data provenance, or the number/qualifications of experts involved in establishing ground truth for AI/ML
- Adjudication methods, MRMC studies, standalone AI performance, or types of ground truth for an AI/ML system
- Training set sample size or how ground truth for a training set was established for an AI/ML system
Therefore, I cannot fulfill your request for this specific document.
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