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The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.

The predicate Skeletal Dynamics Distal Elbow Plating System (K171590) consists of medical grade titanium alloy radial head plates, proximal ulna plates, double hockey stick, Y and coronoid plates designed for fracture fixation, fusions, osteotomies and non-unions of the proximal radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.

The system is provided non-sterile and is sterilized in the user facility.

The modifications to the currently marketed Distal Elbow Plating System include the following.

• . Two new Proximal Ulna Plate extension options
• New 3.5mm FreeFix™ screw options .
• Addition of Protean Radial Head Plate configurations. .
• Addition of Modified Proximal Ulna Plate configurations. .

The provided text is a 510(k) premarket notification for a medical device called the "Distal Elbow Plating Sytem." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and performance testing for mechanical properties.

Crucially, this document does NOT describe an AI/ML-driven device or study involving acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or human-in-the-loop studies.

Therefore, I cannot extract the information required by your prompt, such as:

• A table of acceptance criteria and reported device performance (in the context of AI/ML diagnostic performance)
• Sample size for test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for training set
• How ground truth for training set was established

The "Performance Testing" section in the document refers to mechanical testing (e.g., ASTM standards for metallic bone plates and screws) to ensure the physical integrity and strength of the implant device, not its performance as a diagnostic or AI-assisted tool.

In summary, this document is entirely unrelated to the type of AI/ML device performance study details requested in your prompt.

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The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

The Skeletal Dynamics Distal Elbow Plating System is comprised of:

• Titanium alloy plates and screws in various configurations
• Cobalt chrome polyaxial screws
• Stainless steel K-wires (for provisional fixation not for implantation)
• System specific instrumentation

The current Skeletal Dynamics Distal Elbow Plating System (K140892) includes the radial head and proximal ulna plates. Plates in double hockey stick, Y and coronoid shape configurations with the same node and inter-node features as the radial head plate are being added for use in the proximal radius and ulna in this submission. All plates are made of medical grade titanium alloy. The radial head, proximal ulna and coronoid plates are offered in left and right applications, the proximal ulna plate is provided in various lengths, and the double hockey stick and Y plates are in single size and have bilateral application. Additional screws length as well as new threaded pegs, washers, polyaxial locking screws, and instruments have been added in the subject system in this submission. The system is provided non-sterile and is sterilized in the user facility.

This document is a 510(k) premarket notification for a medical device called the "Skeletal Dynamics Distal Elbow Plating System." It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria and study design for an AI/ML device, such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment, cannot be found in this document.

The document describes a traditional orthopaedic medical device (bone plates and screws) and demonstrates its substantial equivalence to previously cleared predicate devices through engineering analysis and preclinical mechanical testing, adhering to ASTM standards. There is no mention of algorithms, artificial intelligence, or machine learning.

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The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

The Skeletal Dynamics Distal Elbow System consists of various bone plates designed for fracture fixation, fusions, osteotomies and non-unions of the radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.

The Radial Head and the Proximal Ulna plates are made of medical grade titanium alloy. They are offered in left and right applications. The Proximal Ulna plate is provided in various lengths. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics Fragment Plate System is comprised of:

• · Titanium alloy plates and screws
• Cobalt chrome polyaxial screws
• · Stainless steel K-wires (for provisional fixation not for implantation)
• · System specific instrumentation.

This document is a 510(k) premarket notification for the "Skeletal Dynamics Distal Elbow Plating System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on performance testing. However, it does not contain the level of detail requested for acceptance criteria and a study proving those criteria are met for an AI-powered diagnostic device.

Here's why and what information is missing:

• This document describes a medical device (bone plating system), not an AI diagnostic device. The questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are highly specific to AI/ML diagnostic tools. These concepts are not applicable to the mechanical bone plating system described here.
• The "Performance Testing" section states mechanical testing was performed, including static and dynamic testing on plates, and pullout strength and torque testing on screws. This is typical for orthopedic implants to demonstrate structural integrity and mechanical equivalence.
• The "Acceptance Criteria" for this type of device would generally involve meeting certain mechanical performance thresholds (e.g., strength, fatigue life, screw retention) set by recognized standards (like ASTM or ISO) relevant to orthopedic implants. These specific criteria and the detailed results showing compliance are summarized but not explicitly listed in this FDA letter, which instead focuses on the determination of substantial equivalence.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text because it pertains to a different type of medical device (a mechanical implant) than what your questions are designed for (an AI diagnostic tool).

If this document were about an AI diagnostic device, the necessary information would typically include sections detailing clinical study design, endpoints, statistical analysis, and comparisons to human performance or ground truth.

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